Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults (NCT NCT04177355)
NCT ID: NCT04177355
Last Updated: 2025-09-02
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
PHASE1
Target enrollment
127 participants
Primary outcome timeframe
Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Results posted on
2025-09-02
Participant Flow
Participant milestones
| Measure |
Part A, Group T1
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part B, Group T7
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group T8
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group C3
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
2
|
20
|
19
|
20
|
20
|
9
|
10
|
10
|
2
|
|
Overall Study
Safety Population
|
5
|
10
|
2
|
20
|
19
|
20
|
20
|
9
|
10
|
10
|
2
|
|
Overall Study
Received Optional Second Boost at 6 Months (Part A)
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
8
|
2
|
18
|
16
|
20
|
19
|
9
|
9
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
2
|
3
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A, Group T1
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part B, Group T7
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group T8
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group C3
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
Baseline characteristics by cohort
| Measure |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=5 Participants
|
25.5 years
n=7 Participants
|
23.5 years
n=5 Participants
|
28 years
n=4 Participants
|
32 years
n=21 Participants
|
28 years
n=8 Participants
|
26.5 years
n=8 Participants
|
33 years
n=24 Participants
|
30 years
n=42 Participants
|
36 years
n=42 Participants
|
44 years
n=42 Participants
|
29 years
n=42 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
18-20 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Age, Customized
21-30 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
64 Participants
n=42 Participants
|
|
Age, Customized
31-40 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Age, Customized
41-50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
18 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
71 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
114 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
93 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
USA
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
127 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6Population: Started (enrolled).
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 |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
None
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Mild
|
4 Participants
|
4 Participants
|
1 Participants
|
14 Participants
|
12 Participants
|
15 Participants
|
19 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Moderate
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6Population: Started (enrolled).
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 |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
5 Participants
|
8 Participants
|
2 Participants
|
19 Participants
|
19 Participants
|
20 Participants
|
20 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
4 Participants
|
8 Participants
|
2 Participants
|
20 Participants
|
16 Participants
|
20 Participants
|
19 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
4 Participants
|
8 Participants
|
2 Participants
|
19 Participants
|
16 Participants
|
20 Participants
|
19 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6Population: Started (enrolled).
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 |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Malaise and/or fatigue · Severe
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Malaise and/or fatigue · None
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Malaise and/or fatigue · Mild
|
2 Participants
|
2 Participants
|
0 Participants
|
11 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Malaise and/or fatigue · Moderate
|
2 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Myalgia · None
|
1 Participants
|
1 Participants
|
2 Participants
|
16 Participants
|
2 Participants
|
13 Participants
|
15 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Myalgia · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Myalgia · Moderate
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Myalgia · Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Headache · None
|
0 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
2 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Headache · Mild
|
3 Participants
|
4 Participants
|
0 Participants
|
10 Participants
|
12 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Headache · Moderate
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Headache · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Nausea · None
|
3 Participants
|
3 Participants
|
2 Participants
|
17 Participants
|
7 Participants
|
16 Participants
|
15 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Nausea · Mild
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Chills · None
|
2 Participants
|
4 Participants
|
2 Participants
|
17 Participants
|
3 Participants
|
14 Participants
|
19 Participants
|
8 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Chills · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Chills · Moderate
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Chills · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Arthralgia · None
|
2 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
5 Participants
|
17 Participants
|
16 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Arthralgia · Moderate
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Arthralgia · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Max. Systemic Symptoms · None
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Max. Systemic Symptoms · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
4 Participants
|
10 Participants
|
10 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
3 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Max. Systemic Symptoms · Severe
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Temperature · None
|
3 Participants
|
6 Participants
|
2 Participants
|
18 Participants
|
3 Participants
|
20 Participants
|
20 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Temperature · Mild
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do 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 meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Neutrophils (1000 cells/cubic mm)- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Hemoglobin (g/dL)- Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Hemoglobin (g/dL)- Day 364
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
ALT (SGPT) (U/L)- Day 14
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
ALT (SGPT) (U/L)- Day 70
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
ALT (SGPT) (U/L)- Day 182
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
ALT (SGPT) (U/L)- Day 364
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Creatinine (mg/dL)- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Creatinine (mg/dL)- Day 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Creatinine (mg/dL)- Day 364
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C)Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do 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 Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Outcome measures
| Measure |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Moderate
|
2 Participants
|
3 Participants
|
0 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Mild
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Severe
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C)Population: Started (enrolled).
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Withdrawal by Subject
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Investigator decision
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant refused study product administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Lost to Follow-Up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unsolicited adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant unable to adhere to visit schedule
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Solicited adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Relocated, however participant agreed to continued follow-up with phone calls
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not discontinue SPA
|
4 Participants
|
9 Participants
|
2 Participants
|
19 Participants
|
15 Participants
|
20 Participants
|
19 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)Population: Started (enrolled).
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Outcome measures
| Measure |
Part A, Group T1
n=5 Participants
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 Participants
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 Participants
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 Participants
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 Participants
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 Participants
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 Participants
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part C, Group T7
n=10 Participants
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group T8
n=10 Participants
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part C, Group C3
n=2 Participants
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Participant refused further participation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Unable to contact participant
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Participant relocated, no follow-up planned
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Study Termination and Reason for Early Study Termination
Scheduled exit visit/end of study
|
5 Participants
|
8 Participants
|
2 Participants
|
18 Participants
|
16 Participants
|
20 Participants
|
19 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
2 Participants
|
Adverse Events
Part A, Group T1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A, Group T2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part A, Group C1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Group T3
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Part B, Group T4
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part B, Group T5
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Part B, Group T6
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Part B, Group C2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B, Group T7
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B, Group T8
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B, Group C3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group T1
n=5 participants at risk
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 participants at risk
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 participants at risk
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 participants at risk
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 participants at risk
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 participants at risk
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 participants at risk
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 participants at risk
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part B, Group T7
n=10 participants at risk
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group T8
n=10 participants at risk
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group C3
n=2 participants at risk
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Appendicitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Vertebrobasilar artery dissection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
Other adverse events
| Measure |
Part A, Group T1
n=5 participants at risk
BG505 SOSIP.664 gp140 \& (1 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group T2
n=10 participants at risk
BG505 SOSIP.664 gp140 \& (5 mcg 3M-052-AF + Alum) mo(0,2)
|
Part A, Group C1
n=2 participants at risk
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2)
|
Part B, Group T3
n=20 participants at risk
BG505 SOSIP.664 gp140 \& (CpG 1018 + Alum) mo(0,2,6)
|
Part B, Group T4
n=19 participants at risk
BG505 SOSIP.664 gp140 \& (3M-052-AF + Alum) mo(0,2,6)
|
Part B, Group T5
n=20 participants at risk
BG505 SOSIP.664 gp140 \& GLA-LSQ mo(0,2,6)
|
Part B, Group T6
n=20 participants at risk
BG505 SOSIP.664 gp140 \& Alum mo(0,2,6)
|
Part B, Group C2
n=9 participants at risk
Placebo for BG505 SOSIP.664 gp140 \& adjuvant mo(0,2,6)
|
Part B, Group T7
n=10 participants at risk
BG505 SOSIP.664 gp140 \& (3mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group T8
n=10 participants at risk
Trimer 4571 \& (5mcg 3M-052-AF+Alum) mo(0,2,6)
|
Part B, Group C3
n=2 participants at risk
Placebo for BG505 SOSIP.664 gp140/Trimer 4571 \& adjuvant mo(0,2,6)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
70.0%
7/10 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
63.2%
12/19 • Number of events 12 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
4/20 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
25.0%
5/20 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
70.0%
7/10 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
80.0%
8/10 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Chest pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Chills (Solicited)
|
60.0%
3/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
60.0%
6/10 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
84.2%
16/19 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
6/20 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
5/10 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Fatigue
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site erythema (Solicited)
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
4/20 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.5%
2/19 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site pain (Solicited)
|
100.0%
5/5 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
75.0%
15/20 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
19/19 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
80.0%
16/20 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
95.0%
19/20 • Number of events 19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
55.6%
5/9 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injection site swelling (Solicited)
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
21.1%
4/19 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Injury associated with device
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Malaise (Solicited)
|
100.0%
5/5 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
70.0%
14/20 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
94.7%
18/19 • Number of events 18 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
75.0%
15/20 • Number of events 15 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
65.0%
13/20 • Number of events 13 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
66.7%
6/9 • Number of events 6 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
90.0%
9/10 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Pyrexia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
General disorders
Vaccination site pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Anal chlamydia infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
35.0%
7/20 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
26.3%
5/19 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
40.0%
8/20 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
4/20 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
22.2%
2/9 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Ear infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Lyme disease
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Mycoplasma genitalium infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Nipple infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Tinea infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Tinea versicolour
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
22.2%
2/9 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Viral infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Poisoning
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
3/5 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Blood glucose increased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Blood pressure increased
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Body temperature increased (Solicited)
|
40.0%
2/5 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
40.0%
4/10 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
84.2%
16/19 • Number of events 16 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
2/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
30.0%
3/10 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.5%
2/19 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
60.0%
3/5 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
70.0%
7/10 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
73.7%
14/19 • Number of events 14 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
4/20 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
80.0%
8/10 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
5/10 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
80.0%
4/5 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
90.0%
9/10 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
20.0%
4/20 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
89.5%
17/19 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
35.0%
7/20 • Number of events 7 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
25.0%
5/20 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
33.3%
3/9 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
90.0%
9/10 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
80.0%
8/10 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Brain fog
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.5%
2/19 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
1/2 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Headache (Solicited)
|
100.0%
5/5 • Number of events 5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
100.0%
10/10 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
10/20 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
89.5%
17/19 • Number of events 17 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
40.0%
8/20 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
50.0%
10/20 • Number of events 10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
44.4%
4/9 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
80.0%
8/10 • Number of events 8 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
90.0%
9/10 • Number of events 9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
2/20 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.5%
2/19 • Number of events 3 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
15.0%
3/20 • Number of events 4 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
10.0%
1/10 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Fixed eruption
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.3%
1/19 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
5.0%
1/20 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/9 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/5 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/19 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/20 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
11.1%
1/9 • Number of events 1 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/10 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
0.00%
0/2 • The AE reporting period for this study comprises the entire study period for each individual participant (from the participant's study enrollment until his or her study completion or discontinuation), up to 18 months
The number (percentage) of Participants Reporting Solicited AEs and unsolicited AEs including All-Cause Mortality, Serious Adverse Events (SAEs), and Other (Not Including Serious) Adverse Events were summarized by arm
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place