Trial Outcomes & Findings for Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women (NCT NCT01150123)
NCT ID: NCT01150123
Last Updated: 2017-05-15
Results Overview
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
678 participants
Primary outcome timeframe
Day 1 and Day 61
Results posted on
2017-05-15
Participant Flow
Subjects were enrolled at one center in Belgium
Group1: 5 µg-1Inj-No Adj, 5 µg-2Inj-No Adj, 20 µg-1Inj-No Adj, 20 µg-2Inj-No Adj (Cohort 1), 5 µg-1Inj-Alum, 5 µg-2Inj-Alum, 20 µg-1Inj-Alum, 20 µg-2Inj-Alum (Cohort 2). Group 2: 5 µg-1Inj-MF59\_F, 5 µg-2Inj-MF59\_F, 20 µg-1Inj-MF59\_F, 20 µg-2Inj-MF59\_F (Cohort 3), 5 µg-1Inj-MF59\_H, 5 µg-2Inj-MF59\_H, 20 µg-1Inj-MF59\_H, 20 µg-2Inj-MF59\_H (Cohort 4)
Participant milestones
| Measure |
5 µg-1 Inj - No Adj
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5 µg-2 Inj - No Adj
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5 µg-1 Inj - Alum
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5 µg-2 Inj - Alum
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
Subjects received two injections of placebo administered 1 month apart
|
5 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5 µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
39
|
40
|
40
|
40
|
39
|
40
|
20
|
40
|
40
|
40
|
40
|
40
|
40
|
40
|
40
|
20
|
|
Overall Study
COMPLETED
|
37
|
38
|
35
|
37
|
37
|
34
|
39
|
37
|
15
|
39
|
38
|
39
|
37
|
40
|
40
|
39
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
4
|
3
|
3
|
6
|
0
|
3
|
5
|
1
|
2
|
1
|
3
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
5 µg-1 Inj - No Adj
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5 µg-2 Inj - No Adj
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5 µg-1 Inj - Alum
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5 µg-2 Inj - Alum
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
Subjects received two injections of placebo administered 1 month apart
|
5 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5 µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
1
|
1
|
1
|
0
|
3
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
2
|
5
|
0
|
0
|
3
|
1
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Baseline characteristics by cohort
| Measure |
5μg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5μg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 μg-1 Inj - No Adj
n=39 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 μg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5μg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5μg-2 Inj - Alum
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 μg-1 Inj - Alum
n=39 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 μg-2 Inj- Alum
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=20 Participants
Subjects received two injections of placebo administered 1 month apart t
|
5μg-1 Inj -MF59_H
n=40 Participants
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5μg-2 Inj -MF59_H
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 μg-1 Inj -MF59_H
n=40 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 μg-2 Inj -MF59_H
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5μg-1 Inj -MF59_F
n=40 Participants
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5μg-2 Inj -MF59_F
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 μg-1 Inj -MF59_F
n=40 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 μg-2 Inj-MF59_F
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
Total
n=678 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.2 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
25.5 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
26.5 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
25.1 years
STANDARD_DEVIATION 5.3 • n=8 Participants
|
25.1 years
STANDARD_DEVIATION 6.3 • n=8 Participants
|
24.3 years
STANDARD_DEVIATION 6.0 • n=24 Participants
|
23.5 years
STANDARD_DEVIATION 3.2 • n=42 Participants
|
23.4 years
STANDARD_DEVIATION 4.1 • n=42 Participants
|
23.5 years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
23.5 years
STANDARD_DEVIATION 5.2 • n=42 Participants
|
24.7 years
STANDARD_DEVIATION 6.1 • n=36 Participants
|
23.6 years
STANDARD_DEVIATION 5.0 • n=36 Participants
|
24.9 years
STANDARD_DEVIATION 5.9 • n=24 Participants
|
22.7 years
STANDARD_DEVIATION 4.0 • n=135 Participants
|
22.9 years
STANDARD_DEVIATION 5.8 • n=136 Participants
|
23.5 years
STANDARD_DEVIATION 5.3 • n=44 Participants
|
24.3 years
STANDARD_DEVIATION 5.5 • n=667 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
40 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
40 Participants
n=36 Participants
|
40 Participants
n=36 Participants
|
40 Participants
n=24 Participants
|
40 Participants
n=135 Participants
|
40 Participants
n=136 Participants
|
20 Participants
n=44 Participants
|
678 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
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
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 61Population: Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=35 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=38 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=17 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17)
|
38 percentage of subjects
|
30 percentage of subjects
|
30 percentage of subjects
|
29 percentage of subjects
|
30 percentage of subjects
|
38 percentage of subjects
|
35 percentage of subjects
|
20 percentage of subjects
|
18 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 61 (Serogroup Ia)
|
98 percentage of subjects
|
97 percentage of subjects
|
91 percentage of subjects
|
95 percentage of subjects
|
97 percentage of subjects
|
95 percentage of subjects
|
87 percentage of subjects
|
84 percentage of subjects
|
18 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17)
|
24 percentage of subjects
|
12 percentage of subjects
|
18 percentage of subjects
|
17 percentage of subjects
|
26 percentage of subjects
|
16 percentage of subjects
|
24 percentage of subjects
|
9 percentage of subjects
|
18 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16)
|
82 percentage of subjects
|
95 percentage of subjects
|
83 percentage of subjects
|
84 percentage of subjects
|
78 percentage of subjects
|
86 percentage of subjects
|
84 percentage of subjects
|
64 percentage of subjects
|
19 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17)
|
18 percentage of subjects
|
13 percentage of subjects
|
11 percentage of subjects
|
13 percentage of subjects
|
16 percentage of subjects
|
28 percentage of subjects
|
16 percentage of subjects
|
18 percentage of subjects
|
12 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17)
|
70 percentage of subjects
|
81 percentage of subjects
|
77 percentage of subjects
|
79 percentage of subjects
|
67 percentage of subjects
|
86 percentage of subjects
|
70 percentage of subjects
|
76 percentage of subjects
|
12 percentage of subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 61Population: Analysis was done on Primary PPS
Serotype-specific (Ia, Ib \& III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=35 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=38 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=17 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17)
|
0.62 µg/mL
Interval 0.36 to 1.08
|
0.51 µg/mL
Interval 0.28 to 0.94
|
0.38 µg/mL
Interval 0.21 to 0.71
|
0.45 µg/mL
Interval 0.25 to 0.81
|
0.48 µg/mL
Interval 0.26 to 0.87
|
0.57 µg/mL
Interval 0.31 to 1.06
|
0.54 µg/mL
Interval 0.29 to 0.98
|
0.37 µg/mL
Interval 0.2 to 0.67
|
0.25 µg/mL
Interval 0.11 to 0.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17)
|
20 µg/mL
Interval 9.42 to 41.0
|
11 µg/mL
Interval 5.41 to 24.0
|
15 µg/mL
Interval 7.08 to 34.0
|
18 µg/mL
Interval 8.34 to 37.0
|
14 µg/mL
Interval 6.54 to 30.0
|
9.99 µg/mL
Interval 4.67 to 21.0
|
9.64 µg/mL
Interval 4.55 to 20.0
|
6.49 µg/mL
Interval 3.03 to 14.0
|
0.25 µg/mL
Interval 0.083 to 0.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 )
|
0.15 µg/mL
Interval 0.089 to 0.25
|
0.11 µg/mL
Interval 0.065 to 0.19
|
0.11 µg/mL
Interval 0.064 to 0.19
|
0.11 µg/mL
Interval 0.062 to 0.18
|
0.15 µg/mL
Interval 0.088 to 0.26
|
0.12 µg/mL
Interval 0.068 to 0.21
|
0.12 µg/mL
Interval 0.072 to 0.21
|
0.081 µg/mL
Interval 0.046 to 0.14
|
0.16 µg/mL
Interval 0.072 to 0.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16)
|
6.75 µg/mL
Interval 3.21 to 14.0
|
4.56 µg/mL
Interval 2.15 to 9.69
|
4.26 µg/mL
Interval 1.95 to 9.34
|
4.45 µg/mL
Interval 2.09 to 9.44
|
4.72 µg/mL
Interval 2.2 to 10.0
|
3.85 µg/mL
Interval 1.79 to 8.24
|
3.92 µg/mL
Interval 1.85 to 8.32
|
2.06 µg/mL
Interval 0.95 to 4.46
|
0.24 µg/mL
Interval 0.075 to 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17)
|
0.13 µg/mL
Interval 0.08 to 0.2
|
0.089 µg/mL
Interval 0.056 to 0.14
|
0.087 µg/mL
Interval 0.054 to 0.14
|
0.077 µg/mL
Interval 0.049 to 0.12
|
0.099 µg/mL
Interval 0.062 to 0.16
|
0.15 µg/mL
Interval 0.096 to 0.25
|
0.09 µg/mL
Interval 0.057 to 0.14
|
0.12 µg/mL
Interval 0.074 to 0.19
|
0.1 µg/mL
Interval 0.05 to 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17)
|
3.27 µg/mL
Interval 1.6 to 6.68
|
3.23 µg/mL
Interval 1.54 to 6.78
|
2.31 µg/mL
Interval 1.08 to 4.95
|
2.35 µg/mL
Interval 1.13 to 4.89
|
1.49 µg/mL
Interval 0.7 to 3.15
|
4.3 µg/mL
Interval 2.05 to 9.04
|
1.4 µg/mL
Interval 0.67 to 2.94
|
3.28 µg/mL
Interval 1.56 to 6.89
|
0.1 µg/mL
Interval 0.035 to 0.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 61/Day 1Population: Analysis was done on Primary PPS.
Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=34 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=36 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=36 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=37 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=17 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
serotype Ia; N=40,33,32,35,33,32,34,35,17
|
32 Ratios
Interval 19.0 to 53.0
|
28 Ratios
Interval 16.0 to 50.0
|
37 Ratios
Interval 21.0 to 66.0
|
45 Ratios
Interval 26.0 to 78.0
|
36 Ratios
Interval 20.0 to 64.0
|
23 Ratios
Interval 13.0 to 42.0
|
25 Ratios
Interval 14.0 to 44.0
|
19 Ratios
Interval 11.0 to 33.0
|
1.01 Ratios
Interval 0.46 to 2.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Serotype Ib; N=37,33,33,35,34,32,34,31,16
|
47 Ratios
Interval 29.0 to 77.0
|
46 Ratios
Interval 27.0 to 78.0
|
39 Ratios
Interval 23.0 to 66.0
|
47 Ratios
Interval 28.0 to 79.0
|
38 Ratios
Interval 22.0 to 63.0
|
32 Ratios
Interval 19.0 to 54.0
|
33 Ratios
Interval 20.0 to 55.0
|
23 Ratios
Interval 13.0 to 39.0
|
1.55 Ratios
Interval 0.73 to 3.28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Serotype III
|
26 Ratios
Interval 16.0 to 43.0
|
36 Ratios
Interval 22.0 to 61.0
|
26 Ratios
Interval 15.0 to 45.0
|
30 Ratios
Interval 18.0 to 50.0
|
15 Ratios
Interval 8.71 to 25.0
|
30 Ratios
Interval 18.0 to 50.0
|
16 Ratios
Interval 9.48 to 26.0
|
30 Ratios
Interval 18.0 to 50.0
|
1.13 Ratios
Interval 0.52 to 2.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 361Population: Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis
The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=32 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=32 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=35 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=34 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=33 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=34 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=36 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=17 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
n=37 Participants
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
n=38 Participants
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
n=38 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
n=38 Participants
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
n=38 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 1 (Serogroup Ia)
|
38 percentage of subjects
|
28 percentage of subjects
|
28 percentage of subjects
|
29 percentage of subjects
|
35 percentage of subjects
|
39 percentage of subjects
|
35 percentage of subjects
|
22 percentage of subjects
|
18 percentage of subjects
|
30 percentage of subjects
|
29 percentage of subjects
|
16 percentage of subjects
|
28 percentage of subjects
|
29 percentage of subjects
|
38 percentage of subjects
|
21 percentage of subjects
|
31 percentage of subjects
|
20 percentage of subjects
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 1 (Serogroup Ib)
|
24 percentage of subjects
|
13 percentage of subjects
|
15 percentage of subjects
|
17 percentage of subjects
|
26 percentage of subjects
|
15 percentage of subjects
|
24 percentage of subjects
|
9 percentage of subjects
|
18 percentage of subjects
|
24 percentage of subjects
|
15 percentage of subjects
|
6 percentage of subjects
|
26 percentage of subjects
|
23 percentage of subjects
|
19 percentage of subjects
|
6 percentage of subjects
|
11 percentage of subjects
|
24 percentage of subjects
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 1 (Serogroup III)
|
18 percentage of subjects
|
14 percentage of subjects
|
12 percentage of subjects
|
13 percentage of subjects
|
16 percentage of subjects
|
30 percentage of subjects
|
16 percentage of subjects
|
18 percentage of subjects
|
12 percentage of subjects
|
14 percentage of subjects
|
11 percentage of subjects
|
5 percentage of subjects
|
8 percentage of subjects
|
14 percentage of subjects
|
14 percentage of subjects
|
11 percentage of subjects
|
8 percentage of subjects
|
0 percentage of subjects
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 361 (Serogroup Ia)
|
85 percentage of subjects
|
78 percentage of subjects
|
88 percentage of subjects
|
86 percentage of subjects
|
86 percentage of subjects
|
92 percentage of subjects
|
79 percentage of subjects
|
75 percentage of subjects
|
14 percentage of subjects
|
78 percentage of subjects
|
82 percentage of subjects
|
76 percentage of subjects
|
95 percentage of subjects
|
69 percentage of subjects
|
92 percentage of subjects
|
76 percentage of subjects
|
90 percentage of subjects
|
20 percentage of subjects
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 361 (Serogroup Ib)
|
95 percentage of subjects
|
92 percentage of subjects
|
91 percentage of subjects
|
97 percentage of subjects
|
92 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
89 percentage of subjects
|
46 percentage of subjects
|
92 percentage of subjects
|
100 percentage of subjects
|
87 percentage of subjects
|
97 percentage of subjects
|
95 percentage of subjects
|
97 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
22 percentage of subjects
|
|
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Day 361 (Serogroup III)
|
85 percentage of subjects
|
84 percentage of subjects
|
82 percentage of subjects
|
95 percentage of subjects
|
76 percentage of subjects
|
95 percentage of subjects
|
87 percentage of subjects
|
89 percentage of subjects
|
20 percentage of subjects
|
86 percentage of subjects
|
95 percentage of subjects
|
92 percentage of subjects
|
100 percentage of subjects
|
87 percentage of subjects
|
100 percentage of subjects
|
89 percentage of subjects
|
92 percentage of subjects
|
6 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 1 and Day 361Population: Analysis was done on Co-Primary PPS
Serotype-specific (Ia, Ib \& III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=34 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=38 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=38 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=38 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=17 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
n=37 Participants
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
n=38 Participants
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
n=38 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
n=39 Participants
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
n=38 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day1(Serotype Ia)
|
0.62 µg/mL
Interval 0.36 to 1.07
|
0.45 µg/mL
Interval 0.25 to 0.84
|
0.36 µg/mL
Interval 0.2 to 0.67
|
0.45 µg/mL
Interval 0.25 to 0.8
|
0.53 µg/mL
Interval 0.29 to 0.96
|
0.62 µg/mL
Interval 0.34 to 1.14
|
0.54 µg/mL
Interval 0.3 to 0.97
|
0.37 µg/mL
Interval 0.21 to 0.66
|
0.25 µg/mL
Interval 0.11 to 0.58
|
0.54 µg/mL
Interval 0.32 to 0.91
|
0.43 µg/mL
Interval 0.25 to 0.72
|
0.27 µg/mL
Interval 0.16 to 0.45
|
0.36 µg/mL
Interval 0.22 to 0.61
|
0.44 µg/mL
Interval 0.26 to 0.73
|
0.46 µg/mL
Interval 0.27 to 0.79
|
0.36 µg/mL
Interval 0.21 to 0.6
|
0.45 µg/mL
Interval 0.27 to 0.75
|
0.34 µg/mL
Interval 0.17 to 0.7
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day361(Serotype Ia)
|
5.86 µg/mL
Interval 2.93 to 12.0
|
3.78 µg/mL
Interval 1.85 to 7.72
|
4 µg/mL
Interval 1.9 to 8.41
|
4.6 µg/mL
Interval 2.25 to 9.38
|
5.83 µg/mL
Interval 2.86 to 12.0
|
5.22 µg/mL
Interval 2.56 to 11.0
|
3.78 µg/mL
Interval 1.87 to 7.65
|
2.94 µg/mL
Interval 1.43 to 6.05
|
0.26 µg/mL
Interval 0.08 to 0.81
|
3.62 µg/mL
Interval 1.84 to 7.13
|
3.04 µg/mL
Interval 1.56 to 5.93
|
2.13 µg/mL
Interval 1.09 to 4.15
|
7.19 µg/mL
Interval 3.72 to 14.0
|
2.65 µg/mL
Interval 1.37 to 5.12
|
7.32 µg/mL
Interval 3.72 to 14.0
|
2.67 µg/mL
Interval 1.36 to 5.24
|
4.41 µg/mL
Interval 2.28 to 8.52
|
0.31 µg/mL
Interval 0.12 to 0.77
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day1(Serotype Ib)
|
0.15 µg/mL
Interval 0.089 to 0.25
|
0.12 µg/mL
Interval 0.066 to 0.2
|
0.099 µg/mL
Interval 0.058 to 0.17
|
0.11 µg/mL
Interval 0.062 to 0.18
|
0.15 µg/mL
Interval 0.085 to 0.25
|
0.12 µg/mL
Interval 0.069 to 0.2
|
0.12 µg/mL
Interval 0.073 to 0.21
|
0.079 µg/mL
Interval 0.046 to 0.14
|
0.16 µg/mL
Interval 0.073 to 0.33
|
0.12 µg/mL
Interval 0.071 to 0.21
|
0.1 µg/mL
Interval 0.058 to 0.17
|
0.07 µg/mL
Interval 0.04 to 0.12
|
0.11 µg/mL
Interval 0.062 to 0.18
|
0.15 µg/mL
Interval 0.083 to 0.26
|
0.11 µg/mL
Interval 0.065 to 0.2
|
0.077 µg/mL
Interval 0.044 to 0.13
|
0.09 µg/mL
Interval 0.053 to 0.15
|
0.1 µg/mL
Interval 0.048 to 0.22
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day361(Serotype Ib)
|
4.03 µg/mL
Interval 2.38 to 6.83
|
3.7 µg/mL
Interval 2.15 to 6.36
|
2.86 µg/mL
Interval 1.62 to 5.03
|
3.82 µg/mL
Interval 2.22 to 6.58
|
3.13 µg/mL
Interval 1.82 to 5.38
|
4.59 µg/mL
Interval 2.67 to 7.89
|
3.38 µg/mL
Interval 1.98 to 5.77
|
2.45 µg/mL
Interval 1.41 to 4.24
|
0.81 µg/mL
Interval 0.33 to 2.03
|
2.67 µg/mL
Interval 1.53 to 4.66
|
3.81 µg/mL
Interval 2.19 to 6.61
|
1.88 µg/mL
Interval 1.08 to 3.27
|
5.53 µg/mL
Interval 3.21 to 9.54
|
3.18 µg/mL
Interval 1.85 to 5.48
|
5.19 µg/mL
Interval 2.97 to 9.08
|
3.9 µg/mL
Interval 2.23 to 6.82
|
3.64 µg/mL
Interval 2.11 to 6.27
|
0.18 µg/mL
Interval 0.079 to 0.39
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day1(serotype III)
|
0.13 µg/mL
Interval 0.08 to 0.2
|
0.091 µg/mL
Interval 0.057 to 0.15
|
0.089 µg/mL
Interval 0.055 to 0.15
|
0.077 µg/mL
Interval 0.049 to 0.12
|
0.1 µg/mL
Interval 0.064 to 0.16
|
0.16 µg/mL
Interval 0.1 to 0.26
|
0.09 µg/mL
Interval 0.057 to 0.14
|
0.12 µg/mL
Interval 0.074 to 0.19
|
0.1 µg/mL
Interval 0.05 to 0.2
|
0.1 µg/mL
Interval 0.066 to 0.17
|
0.079 µg/mL
Interval 0.05 to 0.13
|
0.058 µg/mL
Interval 0.037 to 0.092
|
0.067 µg/mL
Interval 0.042 to 0.11
|
0.1 µg/mL
Interval 0.066 to 0.16
|
0.11 µg/mL
Interval 0.067 to 0.17
|
0.078 µg/mL
Interval 0.049 to 0.12
|
0.093 µg/mL
Interval 0.059 to 0.15
|
0.068 µg/mL
Interval 0.036 to 0.13
|
|
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Day361(Serotype III)
|
3.05 µg/mL
Interval 1.78 to 5.2
|
2.71 µg/mL
Interval 1.57 to 4.69
|
2.45 µg/mL
Interval 1.38 to 4.34
|
2.78 µg/mL
Interval 1.61 to 4.81
|
1.77 µg/mL
Interval 1.02 to 3.07
|
4.48 µg/mL
Interval 2.59 to 7.76
|
1.77 µg/mL
Interval 1.03 to 3.03
|
3.46 µg/mL
Interval 1.98 to 6.04
|
0.13 µg/mL
Interval 0.054 to 0.3
|
2.33 µg/mL
Interval 1.42 to 3.8
|
2.67 µg/mL
Interval 1.64 to 4.34
|
2.06 µg/mL
Interval 1.27 to 3.34
|
4.5 µg/mL
Interval 2.78 to 7.26
|
2.62 µg/mL
Interval 1.62 to 4.23
|
4.99 µg/mL
Interval 3.05 to 8.17
|
3.07 µg/mL
Interval 1.87 to 5.02
|
3.51 µg/mL
Interval 2.17 to 5.67
|
0.076 µg/mL
Interval 0.038 to 0.15
|
PRIMARY outcome
Timeframe: Day 1 and day 361Population: Analysis was done on Co-Primary PPS.
GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=39 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=33 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=37 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=36 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=38 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=36 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=14 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
n=37 Participants
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
n=38 Participants
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
n=38 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
n=38 Participants
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
n=37 Participants
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
n=37 Participants
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Day361/Day1(Serotype Ia)
|
9.13 Ratios
Interval 5.74 to 15.0
|
10 Ratios
Interval 6.09 to 17.0
|
9.89 Ratios
Interval 5.87 to 17.0
|
15 Ratios
Interval 8.9 to 24.0
|
14 Ratios
Interval 8.3 to 23.0
|
11 Ratios
Interval 6.58 to 18.0
|
8.93 Ratios
Interval 5.43 to 15.0
|
9.54 Ratios
Interval 5.8 to 16.0
|
0.93 Ratios
Interval 0.43 to 2.01
|
6.75 Ratios
Interval 4.44 to 10.0
|
7.15 Ratios
Interval 4.73 to 11.0
|
7.99 Ratios
Interval 5.29 to 12.0
|
20 Ratios
Interval 13.0 to 30.0
|
6.17 Ratios
Interval 4.09 to 9.33
|
16 Ratios
Interval 10.0 to 24.0
|
7.29 Ratios
Interval 4.8 to 11.0
|
9.83 Ratios
Interval 6.54 to 15.0
|
0.9 Ratios
Interval 0.51 to 1.59
|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Day361/Day1(Serotype Ib)
|
28 Ratios
Interval 19.0 to 40.0
|
37 Ratios
Interval 26.0 to 55.0
|
26 Ratios
Interval 18.0 to 38.0
|
38 Ratios
Interval 26.0 to 55.0
|
23 Ratios
Interval 16.0 to 34.0
|
38 Ratios
Interval 26.0 to 55.0
|
27 Ratios
Interval 19.0 to 39.0
|
30 Ratios
Interval 21.0 to 44.0
|
3.97 Ratios
Interval 2.19 to 7.19
|
23 Ratios
Interval 16.0 to 33.0
|
37 Ratios
Interval 26.0 to 53.0
|
27 Ratios
Interval 18.0 to 39.0
|
54 Ratios
Interval 38.0 to 76.0
|
26 Ratios
Interval 18.0 to 37.0
|
45 Ratios
Interval 31.0 to 66.0
|
49 Ratios
Interval 34.0 to 71.0
|
35 Ratios
Interval 25.0 to 50.0
|
1.75 Ratios
Interval 1.04 to 2.94
|
|
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Day361/Day1(Serotype III)
|
24 Ratios
Interval 16.0 to 35.0
|
30 Ratios
Interval 20.0 to 45.0
|
27 Ratios
Interval 17.0 to 41.0
|
35 Ratios
Interval 23.0 to 53.0
|
17 Ratios
Interval 12.0 to 26.0
|
30 Ratios
Interval 20.0 to 45.0
|
20 Ratios
Interval 13.0 to 29.0
|
31 Ratios
Interval 20.0 to 47.0
|
1.4 Ratios
Interval 0.72 to 2.72
|
22 Ratios
Interval 15.0 to 33.0
|
35 Ratios
Interval 23.0 to 53.0
|
35 Ratios
Interval 24.0 to 53.0
|
65 Ratios
Interval 44.0 to 97.0
|
26 Ratios
Interval 18.0 to 40.0
|
45 Ratios
Interval 30.0 to 68.0
|
38 Ratios
Interval 26.0 to 58.0
|
38 Ratios
Interval 26.0 to 56.0
|
1.24 Ratios
Interval 0.7 to 2.21
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.
Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=39 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=39 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=19 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Myalgia
|
6 participants
|
1 participants
|
7 participants
|
8 participants
|
3 participants
|
5 participants
|
8 participants
|
6 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Any Local
|
30 participants
|
32 participants
|
31 participants
|
35 participants
|
39 participants
|
37 participants
|
38 participants
|
39 participants
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Inj site Induration
|
9 participants
|
13 participants
|
6 participants
|
9 participants
|
12 participants
|
16 participants
|
16 participants
|
15 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Inj site swelling
|
5 participants
|
5 participants
|
5 participants
|
5 participants
|
7 participants
|
8 participants
|
16 participants
|
8 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Ecchymosis
|
5 participants
|
3 participants
|
7 participants
|
2 participants
|
5 participants
|
4 participants
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Redness
|
8 participants
|
8 participants
|
9 participants
|
8 participants
|
9 participants
|
12 participants
|
15 participants
|
14 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Warmth
|
10 participants
|
11 participants
|
9 participants
|
13 participants
|
11 participants
|
14 participants
|
11 participants
|
16 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Inj site Pain
|
28 participants
|
28 participants
|
31 participants
|
34 participants
|
39 participants
|
37 participants
|
38 participants
|
39 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Any Systemic
|
25 participants
|
21 participants
|
22 participants
|
28 participants
|
27 participants
|
20 participants
|
29 participants
|
21 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Chills
|
3 participants
|
2 participants
|
5 participants
|
2 participants
|
3 participants
|
1 participants
|
4 participants
|
4 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Nausea
|
6 participants
|
5 participants
|
8 participants
|
5 participants
|
7 participants
|
6 participants
|
5 participants
|
4 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Malaise
|
7 participants
|
6 participants
|
11 participants
|
11 participants
|
7 participants
|
9 participants
|
12 participants
|
9 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Arthralgia
|
2 participants
|
1 participants
|
3 participants
|
2 participants
|
3 participants
|
3 participants
|
3 participants
|
6 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Headache
|
16 participants
|
15 participants
|
13 participants
|
18 participants
|
19 participants
|
17 participants
|
19 participants
|
11 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Fatigue
|
18 participants
|
9 participants
|
18 participants
|
21 participants
|
19 participants
|
13 participants
|
17 participants
|
13 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Rash
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Fever (≥ 38C)
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
3 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was done on Solicited Safety Set
Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Nausea
|
8 participants
|
8 participants
|
6 participants
|
10 participants
|
5 participants
|
10 participants
|
8 participants
|
13 participants
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Any Local
|
33 participants
|
37 participants
|
36 participants
|
40 participants
|
37 participants
|
38 participants
|
39 participants
|
39 participants
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Inj site Induration
|
5 participants
|
12 participants
|
7 participants
|
12 participants
|
8 participants
|
9 participants
|
14 participants
|
14 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Inj site swelling
|
2 participants
|
9 participants
|
7 participants
|
11 participants
|
8 participants
|
10 participants
|
7 participants
|
13 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Ecchymosis
|
2 participants
|
4 participants
|
4 participants
|
2 participants
|
5 participants
|
4 participants
|
5 participants
|
5 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Redness
|
3 participants
|
11 participants
|
8 participants
|
8 participants
|
6 participants
|
8 participants
|
7 participants
|
17 participants
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Warmth
|
6 participants
|
17 participants
|
14 participants
|
21 participants
|
12 participants
|
14 participants
|
17 participants
|
21 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Inj site Pain
|
32 participants
|
35 participants
|
35 participants
|
40 participants
|
37 participants
|
37 participants
|
39 participants
|
39 participants
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Any Systemic
|
23 participants
|
28 participants
|
23 participants
|
31 participants
|
28 participants
|
31 participants
|
30 participants
|
34 participants
|
13 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Chills
|
2 participants
|
5 participants
|
7 participants
|
9 participants
|
7 participants
|
7 participants
|
5 participants
|
16 participants
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Malaise
|
11 participants
|
17 participants
|
13 participants
|
13 participants
|
17 participants
|
15 participants
|
17 participants
|
20 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Myalgia
|
6 participants
|
11 participants
|
8 participants
|
10 participants
|
14 participants
|
10 participants
|
7 participants
|
17 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Arthralgia
|
1 participants
|
3 participants
|
5 participants
|
3 participants
|
3 participants
|
4 participants
|
4 participants
|
7 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Headache
|
13 participants
|
19 participants
|
14 participants
|
23 participants
|
14 participants
|
23 participants
|
22 participants
|
30 participants
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Fatigue
|
17 participants
|
18 participants
|
18 participants
|
21 participants
|
25 participants
|
20 participants
|
20 participants
|
22 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Rash
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Fever (≥ 38C)
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
5 participants
|
1 participants
|
4 participants
|
6 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 721Population: Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.
Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=39 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=39 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=39 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=19 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Serious AEs
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
6 participants
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Any AEs
|
32 participants
|
33 participants
|
31 participants
|
27 participants
|
32 participants
|
30 participants
|
33 participants
|
32 participants
|
16 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
At least possibly related AEs
|
8 participants
|
11 participants
|
11 participants
|
11 participants
|
4 participants
|
6 participants
|
7 participants
|
5 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Medically attended AEs
|
25 participants
|
24 participants
|
23 participants
|
18 participants
|
26 participants
|
24 participants
|
28 participants
|
27 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 721Population: Analysis was done on Unsolicited Safety Set.
Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=40 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=40 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=40 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=20 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Any AEs
|
30 participants
|
34 participants
|
36 participants
|
38 participants
|
29 participants
|
35 participants
|
34 participants
|
32 participants
|
16 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Serious AEs
|
2 participants
|
2 participants
|
0 participants
|
3 participants
|
3 participants
|
2 participants
|
6 participants
|
2 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
At least possibly related AEs
|
0 participants
|
6 participants
|
5 participants
|
6 participants
|
4 participants
|
2 participants
|
9 participants
|
13 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Medically attended AEs
|
27 participants
|
26 participants
|
26 participants
|
27 participants
|
22 participants
|
28 participants
|
27 participants
|
26 participants
|
10 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 721Population: Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.
The persistence of Serotype-specific (Ia, Ib \& III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=36 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=32 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=29 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=31 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=29 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=27 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=33 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=31 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=9 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 1 (serotype Ia)
|
0.63 µg/mL
Interval 0.35 to 1.11
|
0.45 µg/mL
Interval 0.25 to 0.83
|
0.39 µg/mL
Interval 0.21 to 0.75
|
0.34 µg/mL
Interval 0.19 to 0.64
|
0.55 µg/mL
Interval 0.29 to 1.04
|
0.49 µg/mL
Interval 0.25 to 0.95
|
0.56 µg/mL
Interval 0.31 to 1.01
|
0.34 µg/mL
Interval 0.18 to 0.63
|
0.37 µg/mL
Interval 0.12 to 1.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 721 (Serotype Ia)
|
4.69 µg/mL
Interval 2.23 to 9.89
|
3.48 µg/mL
Interval 1.58 to 7.67
|
3.11 µg/mL
Interval 1.36 to 7.14
|
3.18 µg/mL
Interval 1.42 to 7.09
|
5.1 µg/mL
Interval 2.23 to 12.0
|
3.01 µg/mL
Interval 1.27 to 7.11
|
3.69 µg/mL
Interval 1.69 to 8.03
|
2.17 µg/mL
Interval 0.97 to 4.85
|
0.3 µg/mL
Interval 0.068 to 1.34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6)
|
0.16 µg/mL
Interval 0.089 to 0.28
|
0.11 µg/mL
Interval 0.061 to 0.2
|
0.094 µg/mL
Interval 0.051 to 0.17
|
0.11 µg/mL
Interval 0.063 to 0.2
|
0.18 µg/mL
Interval 0.1 to 0.33
|
0.13 µg/mL
Interval 0.069 to 0.23
|
0.14 µg/mL
Interval 0.078 to 0.27
|
0.085 µg/mL
Interval 0.045 to 0.16
|
0.88 µg/mL
Interval 0.23 to 3.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6)
|
2.92 µg/mL
Interval 1.51 to 5.64
|
2.81 µg/mL
Interval 1.42 to 5.55
|
1.71 µg/mL
Interval 0.85 to 3.46
|
2.64 µg/mL
Interval 1.37 to 5.1
|
2.32 µg/mL
Interval 1.16 to 4.64
|
2.96 µg/mL
Interval 1.47 to 5.99
|
2.55 µg/mL
Interval 1.26 to 5.15
|
1.45 µg/mL
Interval 0.71 to 2.97
|
1.02 µg/mL
Interval 0.22 to 4.68
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6)
|
3.19 µg/mL
Interval 1.77 to 5.77
|
1.89 µg/mL
Interval 1.04 to 3.45
|
1.7 µg/mL
Interval 0.89 to 3.27
|
2.16 µg/mL
Interval 1.2 to 3.91
|
1.26 µg/mL
Interval 0.67 to 2.36
|
3.87 µg/mL
Interval 2.06 to 7.26
|
1.44 µg/mL
Interval 0.8 to 2.6
|
2.68 µg/mL
Interval 1.44 to 4.99
|
0.054 µg/mL
Interval 0.013 to 0.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6)
|
0.14 µg/mL
Interval 0.083 to 0.23
|
0.097 µg/mL
Interval 0.058 to 0.16
|
0.094 µg/mL
Interval 0.053 to 0.17
|
0.079 µg/mL
Interval 0.047 to 0.13
|
0.12 µg/mL
Interval 0.069 to 0.21
|
0.16 µg/mL
Interval 0.095 to 0.28
|
0.095 µg/mL
Interval 0.057 to 0.16
|
0.12 µg/mL
Interval 0.07 to 0.21
|
0.071 µg/mL
Interval 0.021 to 0.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 721Population: Analysis was done on secondary persistence PPS.
The persistence of Serotype-specific (Ia, Ib \& III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=35 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=34 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=34 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=34 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=36 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=33 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=36 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=18 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day 1 (serotype Ia)
|
0.47 µg/mL
Interval 0.27 to 0.81
|
0.48 µg/mL
Interval 0.27 to 0.83
|
0.28 µg/mL
Interval 0.16 to 0.49
|
0.29 µg/mL
Interval 0.17 to 0.51
|
0.46 µg/mL
Interval 0.27 to 0.79
|
0.53 µg/mL
Interval 0.3 to 0.93
|
0.37 µg/mL
Interval 0.21 to 0.62
|
0.49 µg/mL
Interval 0.28 to 0.84
|
0.37 µg/mL
Interval 0.17 to 0.79
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day 721 (Serotype Ia)
|
1.86 µg/mL
Interval 0.9 to 3.83
|
1.97 µg/mL
Interval 0.95 to 4.11
|
1.73 µg/mL
Interval 0.83 to 3.6
|
3.09 µg/mL
Interval 1.49 to 6.44
|
1.66 µg/mL
Interval 0.82 to 3.39
|
5.06 µg/mL
Interval 2.4 to 11.0
|
1.72 µg/mL
Interval 0.85 to 3.47
|
3.32 µg/mL
Interval 1.63 to 6.77
|
0.33 µg/mL
Interval 0.12 to 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9)
|
0.13 µg/mL
Interval 0.074 to 0.23
|
0.092 µg/mL
Interval 0.051 to 0.17
|
0.072 µg/mL
Interval 0.04 to 0.13
|
0.1 µg/mL
Interval 0.058 to 0.19
|
0.15 µg/mL
Interval 0.08 to 0.27
|
0.15 µg/mL
Interval 0.077 to 0.28
|
0.08 µg/mL
Interval 0.045 to 0.14
|
0.094 µg/mL
Interval 0.054 to 0.16
|
0.16 µg/mL
Interval 0.055 to 0.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9)
|
1.7 µg/mL
Interval 0.9 to 3.22
|
1.72 µg/mL
Interval 0.87 to 3.41
|
1.16 µg/mL
Interval 0.59 to 2.27
|
2.99 µg/mL
Interval 1.53 to 5.86
|
2.5 µg/mL
Interval 1.26 to 4.96
|
4.23 µg/mL
Interval 2.02 to 8.84
|
2.47 µg/mL
Interval 1.28 to 4.79
|
1.93 µg/mL
Interval 1.03 to 3.61
|
0.21 µg/mL
Interval 0.063 to 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14)
|
0.11 µg/mL
Interval 0.068 to 0.18
|
0.082 µg/mL
Interval 0.049 to 0.14
|
0.061 µg/mL
Interval 0.037 to 0.1
|
0.071 µg/mL
Interval 0.043 to 0.12
|
0.09 µg/mL
Interval 0.054 to 0.15
|
0.12 µg/mL
Interval 0.069 to 0.2
|
0.077 µg/mL
Interval 0.048 to 0.12
|
0.1 µg/mL
Interval 0.06 to 0.17
|
0.061 µg/mL
Interval 0.028 to 0.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Day721(Serotype III;N=34,32,34,32,33,31,36,33,14)
|
1.72 µg/mL
Interval 1.0 to 2.96
|
1.59 µg/mL
Interval 0.91 to 2.79
|
1.29 µg/mL
Interval 0.75 to 2.23
|
2.48 µg/mL
Interval 1.42 to 4.33
|
2.04 µg/mL
Interval 1.17 to 3.53
|
3.18 µg/mL
Interval 1.8 to 5.61
|
1.78 µg/mL
Interval 1.05 to 3.02
|
2.05 µg/mL
Interval 1.18 to 3.56
|
0.075 µg/mL
Interval 0.032 to 0.17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 721Population: Analysis was done on secondary persistence PPS
GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=36 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=32 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=29 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=31 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=29 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=27 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=33 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=31 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=9 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Day 721/Day 1(Serotype Ia)
|
7.5 Ratios
Interval 4.51 to 12.0
|
7.67 Ratios
Interval 4.47 to 13.0
|
7.89 Ratios
Interval 4.48 to 14.0
|
9.24 Ratios
Interval 5.34 to 16.0
|
9.25 Ratios
Interval 5.25 to 16.0
|
6.15 Ratios
Interval 3.42 to 11.0
|
6.64 Ratios
Interval 3.9 to 11.0
|
6.35 Ratios
Interval 3.67 to 11.0
|
0.82 Ratios
Interval 0.3 to 2.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Day 721/ Day 1 (Serotype Ib)
|
19 Ratios
Interval 12.0 to 28.0
|
26 Ratios
Interval 17.0 to 40.0
|
18 Ratios
Interval 12.0 to 29.0
|
24 Ratios
Interval 15.0 to 36.0
|
13 Ratios
Interval 8.16 to 20.0
|
23 Ratios
Interval 15.0 to 37.0
|
18 Ratios
Interval 11.0 to 28.0
|
17 Ratios
Interval 11.0 to 27.0
|
1.17 Ratios
Interval 0.44 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Day 721/ Day 1 (Serotype III)
|
23 Ratios
Interval 15.0 to 35.0
|
19 Ratios
Interval 13.0 to 30.0
|
18 Ratios
Interval 11.0 to 29.0
|
27 Ratios
Interval 18.0 to 41.0
|
11 Ratios
Interval 6.81 to 16.0
|
24 Ratios
Interval 15.0 to 37.0
|
15 Ratios
Interval 10.0 to 23.0
|
22 Ratios
Interval 14.0 to 35.0
|
0.76 Ratios
Interval 0.28 to 2.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 721Population: Analysis was done on secondary persistence PPS.
GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.
Outcome measures
| Measure |
5µg-1 Inj - No Adj
n=35 Participants
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=34 Participants
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=34 Participants
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=34 Participants
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=36 Participants
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=33 Participants
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=37 Participants
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=36 Participants
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=18 Participants
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Day 721/Day 1 (Serotype III)
|
16 Ratios
Interval 10.0 to 24.0
|
19 Ratios
Interval 12.0 to 30.0
|
21 Ratios
Interval 14.0 to 33.0
|
35 Ratios
Interval 22.0 to 54.0
|
23 Ratios
Interval 15.0 to 35.0
|
27 Ratios
Interval 17.0 to 43.0
|
23 Ratios
Interval 15.0 to 35.0
|
21 Ratios
Interval 13.0 to 32.0
|
1.22 Ratios
Interval 0.62 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Day 721/Day 1 (Serotype Ia)
|
3.98 Ratios
Interval 2.55 to 6.2
|
4.14 Ratios
Interval 2.64 to 6.5
|
6.12 Ratios
Interval 3.9 to 9.6
|
11 Ratios
Interval 6.74 to 17.0
|
3.61 Ratios
Interval 2.33 to 5.6
|
9.61 Ratios
Interval 6.09 to 15.0
|
4.7 Ratios
Interval 3.05 to 7.23
|
6.8 Ratios
Interval 4.39 to 11.0
|
0.89 Ratios
Interval 0.48 to 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Day 721/Day 1 (Serotype Ib)
|
13 Ratios
Interval 8.76 to 20.0
|
19 Ratios
Interval 12.0 to 29.0
|
16 Ratios
Interval 10.0 to 24.0
|
29 Ratios
Interval 19.0 to 44.0
|
17 Ratios
Interval 11.0 to 26.0
|
29 Ratios
Interval 18.0 to 45.0
|
31 Ratios
Interval 20.0 to 47.0
|
20 Ratios
Interval 14.0 to 30.0
|
1.31 Ratios
Interval 0.61 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
5µg-1 Inj - No Adj
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
5µg-2 Inj - No Adj
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
20 µg-1 Inj - No Adj
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
20 µg-2 Inj - No Adj
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
5µg-1 Inj - Alum
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
5µg-2 Inj - Alum
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
20 µg-1 Inj - Alum
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
20 µg-2 Inj- Alum
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo - Group 1
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
5µg-1 Inj - MF59_H
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
5µg-2 Inj - MF59_H
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
20 µg-1 Inj - MF59_H
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
20 µg-2 Inj - MF59_H
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
5µg-1 Inj - MF59_F
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
5µg-2 Inj - MF59_F
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
20 µg-1 Inj - MF59_F
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
20 µg-2 Inj- MF59_F
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo - Group 2
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5µg-1 Inj - No Adj
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=39 participants at risk
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=39 participants at risk
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=39 participants at risk；n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=19 participants at risk；n=20 participants at risk
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
n=40 participants at risk
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
n=40 participants at risk
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 participants at risk
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Hernia
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Pilonidal Cyst
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Tonsillitis Bacterial
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Typhoid Fever
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Decompression Sickness
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Nervous system disorders
Headache
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
Other adverse events
| Measure |
5µg-1 Inj - No Adj
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - No Adj
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
|
20 µg-1 Inj - No Adj
n=39 participants at risk
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj - No Adj
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
|
5µg-1 Inj - Alum
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
|
5µg-2 Inj - Alum
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
|
20 µg-1 Inj - Alum
n=39 participants at risk
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
|
20 µg-2 Inj- Alum
n=39 participants at risk；n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
|
Placebo - Group 1
n=19 participants at risk；n=20 participants at risk
Subjects received two injections of placebo administered 1 month apart
|
5µg-1 Inj - MF59_H
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_H
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_H
n=40 participants at risk
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj - MF59_H
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
|
5µg-1 Inj - MF59_F
n=40 participants at risk
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
5µg-2 Inj - MF59_F
n=40 participants at risk
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
20 µg-1 Inj - MF59_F
n=40 participants at risk
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
|
20 µg-2 Inj- MF59_F
n=40 participants at risk
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
|
Placebo - Group 2
n=20 participants at risk
Subjects received two injections of placebo administered 1 month apart
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Apthous Stomatitis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Skin and subcutaneous tissue disorders
Pityriasis Rosea
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Eye disorders
Eyelid Edema
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Enteritis
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Nausea
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
23.1%
9/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.4%
6/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
5/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Toothache
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Chills
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.8%
5/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.8%
3/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
40.0%
16/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
5/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Fatigue
|
47.5%
19/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
46.2%
18/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.5%
21/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
47.5%
19/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
46.2%
18/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.9%
14/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
36.8%
7/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
45.0%
18/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
47.5%
19/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
55.0%
22/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
65.0%
26/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
20/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
20/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
55.0%
22/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
45.0%
9/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Influenza Like Illness
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Erythema
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
23.1%
9/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
12/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
38.5%
15/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
38.5%
15/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.8%
3/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
4/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Hemorrhage
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.9%
7/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
2/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Induration
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.9%
7/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
12/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
40.0%
16/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.8%
3/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
12/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
12/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
3/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Movement Impairment
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Pain
|
70.0%
28/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
70.0%
28/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
79.5%
31/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
87.5%
35/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
97.5%
39/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
92.5%
37/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
97.4%
38/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
100.0%
39/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
36.8%
7/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
80.0%
32/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
87.5%
35/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
87.5%
35/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
100.0%
40/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
92.5%
37/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
92.5%
37/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
97.5%
39/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
97.5%
39/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
5/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Swelling
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.8%
5/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.5%
8/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.5%
2/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
2/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Injection Site Warmth
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
23.1%
9/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
28.2%
11/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.5%
21/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
12/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.5%
21/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
6/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Malaise
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
28.2%
11/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.8%
12/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
23.1%
9/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.5%
2/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
37.5%
15/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
20/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
30.0%
6/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Immune system disorders
Allergy To Arthropod Bite
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Bronchitis
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Chlamydial Infection
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Coxsackie Viral Infection
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Cystitis
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
2/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Gastroenteritis
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.8%
5/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.4%
6/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
4/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Oral Herpes
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Pharyngitis
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.8%
5/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.8%
5/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
2/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.4%
6/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.6%
10/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.9%
7/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
21.1%
4/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
27.5%
11/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
35.0%
14/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
37.5%
15/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
40.0%
16/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
10/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Urinary Tract Infection
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.1%
2/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.7%
3/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.3%
4/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.4%
6/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.0%
4/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
22.5%
9/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
1/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Backpain
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.5%
8/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.0%
8/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
12.5%
5/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
20.5%
8/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.9%
7/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.5%
2/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
6/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
40.0%
16/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
25.0%
10/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
17.5%
7/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
42.5%
17/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
15.0%
3/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Nervous system disorders
Headache
|
47.5%
19/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
37.5%
15/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.5%
21/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.5%
21/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
47.5%
19/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
51.3%
20/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
41.0%
16/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
52.6%
10/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
32.5%
13/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
20/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
45.0%
18/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
65.0%
26/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
37.5%
15/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
60.0%
24/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
62.5%
25/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
75.0%
30/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
50.0%
10/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted Ovum
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Psychiatric disorders
Burnout Syndrome
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
10.5%
2/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.0%
2/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.6%
1/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
5.3%
1/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/39 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/19 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
7.5%
3/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
2.5%
1/40 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
0.00%
0/20 • Day 1 through Day 721
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Safety analysis was done on As treated set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60