Trial Outcomes & Findings for Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants (NCT NCT00937521)
NCT ID: NCT00937521
Last Updated: 2015-04-07
Results Overview
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1507 participants
Primary outcome timeframe
At baseline (pre-vaccination) and 30 days after the third vaccination.
Results posted on
2015-04-07
Participant Flow
Participant milestones
| Measure |
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study - Prior to Booster Dose
STARTED
|
188
|
190
|
192
|
188
|
191
|
188
|
186
|
184
|
|
Overall Study - Prior to Booster Dose
Premature Withdrawal
|
3
|
5
|
6
|
1
|
3
|
1
|
5
|
1
|
|
Overall Study - Prior to Booster Dose
COMPLETED
|
185
|
185
|
186
|
187
|
188
|
187
|
181
|
183
|
|
Overall Study - Prior to Booster Dose
NOT COMPLETED
|
3
|
5
|
6
|
1
|
3
|
1
|
5
|
1
|
|
Booster Phase
STARTED
|
155
|
163
|
169
|
170
|
168
|
165
|
165
|
161
|
|
Booster Phase
Premature Withdrawal
|
3
|
2
|
5
|
3
|
5
|
5
|
5
|
2
|
|
Booster Phase
COMPLETED
|
152
|
161
|
164
|
167
|
163
|
160
|
160
|
159
|
|
Booster Phase
NOT COMPLETED
|
3
|
2
|
5
|
3
|
5
|
5
|
5
|
2
|
Reasons for withdrawal
| Measure |
B+OMV (Group I)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study - Prior to Booster Dose
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study - Prior to Booster Dose
Withdrawal by Subject
|
2
|
1
|
3
|
0
|
1
|
0
|
2
|
1
|
|
Overall Study - Prior to Booster Dose
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study - Prior to Booster Dose
Inappropriate enrollment
|
0
|
4
|
0
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study - Prior to Booster Dose
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Booster Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Booster Phase
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
2
|
|
Booster Phase
Lost to Follow-up
|
2
|
2
|
4
|
2
|
4
|
4
|
3
|
0
|
|
Booster Phase
Administrative Reason
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Booster Phase
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Baseline characteristics by cohort
| Measure |
B+OMV (Group I)
n=188 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=190 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=192 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=188 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=191 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=188 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=186 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
Total
n=1507 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
188 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
188 Participants
n=8 Participants
|
186 Participants
n=8 Participants
|
184 Participants
n=24 Participants
|
1507 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
98 Participants
n=8 Participants
|
72 Participants
n=24 Participants
|
699 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
95 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
112 Participants
n=24 Participants
|
808 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At baseline (pre-vaccination) and 30 days after the third vaccination.Population: Analysis as per PP population.
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Outcome measures
| Measure |
B+OMV (Group I)
n=171 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=174 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=171 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=174 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=172 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=173 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=171 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=169 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
44/76SLBaseline(N=166,171,168,170,169,168,168,166)
|
5 Percentages of Subjects
Interval 2.0 to 9.0
|
2 Percentages of Subjects
Interval 0.0 to 5.0
|
4 Percentages of Subjects
Interval 1.0 to 8.0
|
4 Percentages of Subjects
Interval 2.0 to 8.0
|
4 Percentages of Subjects
Interval 2.0 to 8.0
|
4 Percentages of Subjects
Interval 2.0 to 8.0
|
2 Percentages of Subjects
Interval 1.0 to 6.0
|
3 Percentages of Subjects
Interval 1.0 to 7.0
|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
44/76-SL > 3rd(N=170,170,166,166,169,167,165,167)
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
99 Percentages of Subjects
Interval 96.0 to 100.0
|
6 Percentages of Subjects
Interval 3.0 to 11.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
5/99-Baseline (N=162,162,161,161,166,166,161,157)
|
5 Percentages of Subjects
Interval 2.0 to 9.0
|
3 Percentages of Subjects
Interval 1.0 to 7.0
|
6 Percentages of Subjects
Interval 3.0 to 10.0
|
4 Percentages of Subjects
Interval 2.0 to 9.0
|
8 Percentages of Subjects
Interval 5.0 to 14.0
|
4 Percentages of Subjects
Interval 2.0 to 8.0
|
6 Percentages of Subjects
Interval 3.0 to 10.0
|
4 Percentages of Subjects
Interval 1.0 to 8.0
|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
5/99 > 3rd (N=165,167,161,166,165,161,159,160)
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
100 Percentages of Subjects
Interval 98.0 to 100.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
3 Percentages of Subjects
Interval 1.0 to 7.0
|
99 Percentages of Subjects
Interval 97.0 to 100.0
|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
NZ98/254Baseline(N=170,174,171,174,171,173,171,169
|
1 Percentages of Subjects
Interval 0.015 to 3.0
|
0 Percentages of Subjects
Interval 0.0 to 2.0
|
1 Percentages of Subjects
Interval 0.015 to 3.0
|
1 Percentages of Subjects
Interval 0.015 to 3.0
|
1 Percentages of Subjects
Interval 0.0 to 4.0
|
1 Percentages of Subjects
Interval 0.0 to 4.0
|
2 Percentages of Subjects
Interval 0.0 to 5.0
|
1 Percentages of Subjects
Interval 0.015 to 3.0
|
|
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168)
|
78 Percentages of Subjects
Interval 71.0 to 84.0
|
67 Percentages of Subjects
Interval 59.0 to 74.0
|
56 Percentages of Subjects
Interval 48.0 to 64.0
|
1 Percentages of Subjects
Interval 0.015 to 3.0
|
62 Percentages of Subjects
Interval 54.0 to 69.0
|
81 Percentages of Subjects
Interval 74.0 to 87.0
|
2 Percentages of Subjects
Interval 0.0 to 5.0
|
74 Percentages of Subjects
Interval 67.0 to 81.0
|
PRIMARY outcome
Timeframe: Day 1 to day 3 after first vaccination.Population: The analysis was done on the Safety Population.
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Outcome measures
| Measure |
B+OMV (Group I)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=186 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=177 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=179 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
|
94 Subjects
|
91 Subjects
|
74 Subjects
|
24 Subjects
|
60 Subjects
|
76 Subjects
|
21 Subjects
|
46 Subjects
|
SECONDARY outcome
Timeframe: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)Population: Per Protocol Primary and Booster populations.
ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: 1. One month after third vaccination. 2. One month after booster vaccination (Men B at 12 months of age).
Outcome measures
| Measure |
B+OMV (Group I)
n=171 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=174 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=171 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=174 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=172 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=173 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=171 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=169 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL Base(N=166,171,168,170,169,168,168,166)
|
1.25 Titers
Interval 1.14 to 1.37
|
1.12 Titers
Interval 1.03 to 1.23
|
1.2 Titers
Interval 1.1 to 1.32
|
1.19 Titers
Interval 1.08 to 1.3
|
1.31 Titers
Interval 1.19 to 1.43
|
1.2 Titers
Interval 1.09 to 1.31
|
1.16 Titers
Interval 1.09 to 1.25
|
1.18 Titers
Interval 1.08 to 1.3
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > 3(N=170,170,166,166,169,167,165,167)
|
101 Titers
Interval 90.0 to 113.0
|
112 Titers
Interval 101.0 to 126.0
|
113 Titers
Interval 101.0 to 126.0
|
62 Titers
Interval 56.0 to 70.0
|
71 Titers
Interval 64.0 to 80.0
|
102 Titers
Interval 92.0 to 114.0
|
1.24 Titers
Interval 1.11 to 1.39
|
102 Titers
Interval 91.0 to 115.0
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL - Base Boost(N=69,78,74,78,71,71,74,70)
|
4.94 Titers
Interval 3.76 to 6.5
|
5.22 Titers
Interval 4.03 to 6.76
|
5.72 Titers
Interval 4.41 to 7.42
|
5.44 Titers
Interval 4.19 to 7.06
|
3.96 Titers
Interval 3.02 to 5.18
|
3.76 Titers
Interval 2.87 to 4.94
|
1.15 Titers
Interval 1.03 to 1.29
|
4.51 Titers
Interval 3.43 to 5.95
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > Boost(N=65,73,70,75,76,71,75,63)
|
120 Titers
Interval 95.0 to 150.0
|
152 Titers
Interval 122.0 to 189.0
|
118 Titers
Interval 95.0 to 146.0
|
53 Titers
Interval 43.0 to 66.0
|
99 Titers
Interval 79.0 to 122.0
|
105 Titers
Interval 84.0 to 131.0
|
12 Titers
Interval 10.0 to 16.0
|
136 Titers
Interval 107.0 to 172.0
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
5/99-Baseline-(N=162,162,161,161,166,166,161,157)
|
1.18 Titers
Interval 1.07 to 1.3
|
1.09 Titers
Interval 0.99 to 1.2
|
1.12 Titers
Interval 1.02 to 1.23
|
1.13 Titers
Interval 1.03 to 1.25
|
1.3 Titers
Interval 1.18 to 1.43
|
1.16 Titers
Interval 1.05 to 1.27
|
1.21 Titers
Interval 1.09 to 1.34
|
1.07 Titers
Interval 0.97 to 1.18
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
5/99 > 3 (N=165,167,161,166,165,161,160)
|
396 Titers
Interval 348.0 to 450.0
|
503 Titers
Interval 442.0 to 572.0
|
534 Titers
Interval 469.0 to 608.0
|
389 Titers
Interval 342.0 to 443.0
|
316 Titers
Interval 278.0 to 360.0
|
371 Titers
Interval 326.0 to 422.0
|
1.15 Titers
Interval 1.03 to 1.29
|
455 Titers
Interval 399.0 to 519.0
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
5/99 Base Boost(N=71,76,80,72,77,78,70,71)
|
69 Titers
Interval 53.0 to 88.0
|
91 Titers
Interval 71.0 to 116.0
|
111 Titers
Interval 87.0 to 141.0
|
74 Titers
Interval 57.0 to 94.0
|
54 Titers
Interval 42.0 to 68.0
|
64 Titers
Interval 50.0 to 81.0
|
1.11 Titers
Interval 0.95 to 1.29
|
106 Titers
Interval 82.0 to 136.0
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
5/99 > Boost(N=73,77,79,72,76,74,69,76)
|
1950 Titers
Interval 1573.0 to 2417.0
|
1819 Titers
Interval 1478.0 to 2238.0
|
2238 Titers
Interval 1820.0 to 2751.0
|
730 Titers
Interval 590.0 to 903.0
|
983 Titers
Interval 801.0 to 1205.0
|
1321 Titers
Interval 1074.0 to 1624.0
|
41 Titers
Interval 29.0 to 57.0
|
2182 Titers
Interval 1769.0 to 2691.0
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254-BaselineN=170,174,171,174,171,173,171,169
|
1.02 Titers
Interval 0.99 to 1.06
|
1.02 Titers
Interval 0.99 to 1.05
|
1.03 Titers
Interval 1.0 to 1.06
|
1.04 Titers
Interval 1.0 to 1.07
|
1.03 Titers
Interval 1.0 to 1.06
|
1.04 Titers
Interval 1.01 to 1.08
|
1.06 Titers
Interval 1.0 to 1.13
|
1.02 Titers
Interval 0.99 to 1.05
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
1month after 3rd vaccN=171,172,169,172,169,169,168
|
10 Titers
Interval 8.59 to 12.0
|
7.81 Titers
Interval 6.69 to 9.12
|
5.74 Titers
Interval 4.92 to 6.71
|
1.05 Titers
Interval 0.9 to 1.23
|
6.66 Titers
Interval 5.71 to 7.77
|
11 Titers
Interval 9.16 to 13.0
|
1.05 Titers
Interval 1.01 to 1.1
|
8.48 Titers
Interval 7.24 to 9.93
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143
|
1.6 Titers
Interval 1.43 to 1.8
|
1.28 Titers
Interval 1.15 to 1.43
|
1.23 Titers
Interval 1.1 to 1.37
|
1.11 Titers
Interval 0.99 to 1.24
|
1.35 Titers
Interval 1.21 to 1.5
|
1.41 Titers
Interval 1.26 to 1.57
|
1.03 Titers
Interval 1.0 to 1.06
|
1.48 Titers
Interval 1.32 to 1.66
|
|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
1month after boosterN=138,152,150,149,152,146,140
|
20 Titers
Interval 16.0 to 24.0
|
18 Titers
Interval 15.0 to 22.0
|
11 Titers
Interval 9.07 to 13.0
|
1.67 Titers
Interval 1.38 to 2.03
|
14 Titers
Interval 12.0 to 17.0
|
20 Titers
Interval 16.0 to 24.0
|
2.2 Titers
Interval 1.89 to 2.57
|
20 Titers
Interval 17.0 to 25.0
|
SECONDARY outcome
Timeframe: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 daysPopulation: As per PP population.
To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
Outcome measures
| Measure |
B+OMV (Group I)
n=171 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=169 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL Strain - Baseline (N=166,166)
|
1.25 Titers
Interval 1.14 to 1.37
|
1.18 Titers
Interval 1.08 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > 3rd (N=170,167)
|
101 Titers
Interval 90.0 to 113.0
|
102 Titers
Interval 91.0 to 115.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL Baseline booster (N=69,70)
|
4.94 Titers
Interval 3.76 to 6.5
|
4.51 Titers
Interval 3.43 to 5.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > booster (N=65,63)
|
120 Titers
Interval 95.0 to 150.0
|
136 Titers
Interval 107.0 to 172.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 Strain - Baseline (N=162,157)
|
1.18 Titers
Interval 1.07 to 1.3
|
1.07 Titers
Interval 0.97 to 1.18
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 > 3rd (N=165,160)
|
396 Titers
Interval 348.0 to 450.0
|
455 Titers
Interval 399.0 to 519.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 Baseline booster (N=71,71)
|
69 Titers
Interval 53.0 to 88.0
|
106 Titers
Interval 82.0 to 136.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 > booser (N=73,76)
|
1950 Titers
Interval 1573.0 to 2417.0
|
2182 Titers
Interval 1769.0 to 2691.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 Strain-Baseline (N=170,169)
|
1.02 Titers
Interval 0.99 to 1.06
|
1.02 Titers
Interval 0.99 to 1.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 > 3rd (N=171,168)
|
10 Titers
Interval 8.59 to 12.0
|
8.48 Titers
Interval 7.24 to 9.93
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 Baseline booster (N=141,143)
|
1.6 Titers
Interval 1.43 to 1.8
|
1.48 Titers
Interval 1.32 to 1.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 > booster (N= 138, 140)
|
20 Titers
Interval 16.0 to 24.0
|
20 Titers
Interval 17.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After the third and the booster vaccination.Population: As per PP population.
To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
Outcome measures
| Measure |
B+OMV (Group I)
n=162 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=160 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > 3rd (N=157,157)
|
80 Ratios
Interval 69.0 to 93.0
|
84 Ratios
Interval 72.0 to 97.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
44/76-SL > Booster (N=59,56)
|
24 Ratios
Interval 18.0 to 31.0
|
28 Ratios
Interval 21.0 to 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 > 3rd (N=152,142)
|
345 Ratios
Interval 292.0 to 408.0
|
417 Ratios
Interval 350.0 to 497.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
5/99 > Booster (N=68,68)
|
27 Ratios
Interval 21.0 to 35.0
|
20 Ratios
Interval 16.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 > 3rd (N=162,160)
|
9.65 Ratios
Interval 8.19 to 11.0
|
8.69 Ratios
Interval 7.36 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
NZ98/254 > Booster (N=129,127)
|
12 Ratios
Interval 10.0 to 15.0
|
14 Ratios
Interval 11.0 to 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months (pre-fourth vaccination)Population: The analysis was done on the Per Protocol Booster population.
To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
Outcome measures
| Measure |
B+OMV (Group I)
n=141 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=155 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=155 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=150 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=150 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=153 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=148 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=143 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70)
|
55 Percentages of Subjects
Interval 43.0 to 67.0
|
58 Percentages of Subjects
Interval 46.0 to 69.0
|
66 Percentages of Subjects
Interval 54.0 to 77.0
|
63 Percentages of Subjects
Interval 51.0 to 74.0
|
45 Percentages of Subjects
Interval 33.0 to 57.0
|
44 Percentages of Subjects
Interval 32.0 to 56.0
|
4 Percentages of Subjects
Interval 1.0 to 11.0
|
47 Percentages of Subjects
Interval 35.0 to 59.0
|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
5/99 Pre-Boost(N=71,76,80,72,77,78,70,71)
|
97 Percentages of Subjects
Interval 90.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
97 Percentages of Subjects
Interval 90.0 to 100.0
|
97 Percentages of Subjects
Interval 91.0 to 100.0
|
99 Percentages of Subjects
Interval 93.0 to 100.0
|
1 Percentages of Subjects
Interval 0.036 to 8.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143)
|
12 Percentages of Subjects
Interval 7.0 to 19.0
|
6 Percentages of Subjects
Interval 3.0 to 11.0
|
5 Percentages of Subjects
Interval 2.0 to 10.0
|
3 Percentages of Subjects
Interval 1.0 to 7.0
|
7 Percentages of Subjects
Interval 3.0 to 12.0
|
8 Percentages of Subjects
Interval 4.0 to 13.0
|
0 Percentages of Subjects
Interval 0.0 to 2.0
|
11 Percentages of Subjects
Interval 7.0 to 18.0
|
SECONDARY outcome
Timeframe: 1 month after fourth vaccinationPopulation: The analysis was done on the Per Protocol Booster population.
To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
Outcome measures
| Measure |
B+OMV (Group I)
n=138 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=152 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=150 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=149 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=152 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=146 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=147 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=140 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
44/76-SL > Booster(N=65,73,70,75,76,71,63)
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
97 Percentages of Subjects
Interval 91.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
99 Percentages of Subjects
Interval 92.0 to 100.0
|
84 Percentages of Subjects
Interval 74.0 to 91.0
|
100 Percentages of Subjects
Interval 94.0 to 100.0
|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
5/99 strain (N=73,77,79,72,76,74,76)
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
93 Percentages of Subjects
Interval 84.0 to 98.0
|
100 Percentages of Subjects
Interval 95.0 to 100.0
|
|
Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
NZ98/254 (N=138,152,150,149,152,146,147,140)
|
89 Percentages of Subjects
Interval 83.0 to 94.0
|
89 Percentages of Subjects
Interval 83.0 to 93.0
|
78 Percentages of Subjects
Interval 71.0 to 84.0
|
18 Percentages of Subjects
Interval 12.0 to 25.0
|
83 Percentages of Subjects
Interval 76.0 to 89.0
|
88 Percentages of Subjects
Interval 82.0 to 93.0
|
24 Percentages of Subjects
Interval 18.0 to 32.0
|
90 Percentages of Subjects
Interval 84.0 to 94.0
|
SECONDARY outcome
Timeframe: At 13 monthsPopulation: The analysis was done on the Per Protocol population.
To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
Outcome measures
| Measure |
B+OMV (Group I)
n=138 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=147 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
44/76-SL > Booster (N=65,75)
|
120 Titers
Interval 95.0 to 150.0
|
12 Titers
Interval 10.0 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
5/99 > Booster (N=73,69)
|
1950 Titers
Interval 1573.0 to 2417.0
|
41 Titers
Interval 29.0 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
NZ98/254 > Booster
|
20 Titers
Interval 16.0 to 24.0
|
2.2 Titers
Interval 1.89 to 2.57
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after boosterPopulation: The analysis was done on the Per Protocol population.
To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
Outcome measures
| Measure |
B+OMV (Group I)
n=147 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
44/76-SL > Booster (N=75)
|
84 Percentage of Subjects
Interval 74.0 to 91.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
5/99 > Booster (N=69)
|
93 Percentage of Subjects
Interval 84.0 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
NZ98/254 > Booster
|
24 Percentage of Subjects
Interval 18.0 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through day 7 after second and third vaccination.Population: As per safety dataset.
To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
Outcome measures
| Measure |
B+OMV (Group I)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=186 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=177 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=179 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Second Vaccination (day1-3)
|
90 Subjects
|
82 Subjects
|
76 Subjects
|
35 Subjects
|
74 Subjects
|
89 Subjects
|
30 Subjects
|
33 Subjects
|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
3rd vac d 1-3(N=181,179,185,183,181,180,177,179)
|
55 Subjects
|
50 Subjects
|
36 Subjects
|
15 Subjects
|
40 Subjects
|
53 Subjects
|
12 Subjects
|
20 Subjects
|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
First Vaccination (day1-7)
|
94 Subjects
|
91 Subjects
|
74 Subjects
|
24 Subjects
|
60 Subjects
|
76 Subjects
|
22 Subjects
|
46 Subjects
|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Second Vaccination (day 1-7)
|
90 Subjects
|
82 Subjects
|
77 Subjects
|
36 Subjects
|
74 Subjects
|
90 Subjects
|
30 Subjects
|
35 Subjects
|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
3rd vac d 1-7(N=181,179,185,183,181,180,177,179)
|
55 Subjects
|
53 Subjects
|
38 Subjects
|
16 Subjects
|
42 Subjects
|
54 Subjects
|
14 Subjects
|
20 Subjects
|
|
Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Booster d 1-7(N=155,162,169,168,168,165,164,159)
|
81 Subjects
|
86 Subjects
|
64 Subjects
|
43 Subjects
|
78 Subjects
|
68 Subjects
|
84 Subjects
|
58 Subjects
|
SECONDARY outcome
Timeframe: Day 1 through day 7 after each vaccination.Population: The analysis was performed on the safety population.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
Outcome measures
| Measure |
B+OMV (Group I)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=186 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=177 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=179 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Swelling (First Vacc)
|
58 Subjects
|
49 Subjects
|
55 Subjects
|
24 Subjects
|
48 Subjects
|
60 Subjects
|
15 Subjects
|
41 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Local (First Vacc)
|
163 Subjects
|
155 Subjects
|
153 Subjects
|
123 Subjects
|
141 Subjects
|
157 Subjects
|
127 Subjects
|
137 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Tenderness (First Vacc)
|
114 Subjects
|
116 Subjects
|
111 Subjects
|
54 Subjects
|
97 Subjects
|
121 Subjects
|
48 Subjects
|
79 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Erythema (First Vacc)
|
108 Subjects
|
99 Subjects
|
94 Subjects
|
53 Subjects
|
77 Subjects
|
106 Subjects
|
45 Subjects
|
73 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Induration (First Vacc)
|
101 Subjects
|
98 Subjects
|
85 Subjects
|
48 Subjects
|
86 Subjects
|
84 Subjects
|
25 Subjects
|
82 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Local (Second Vacc)
|
156 Subjects
|
156 Subjects
|
155 Subjects
|
126 Subjects
|
132 Subjects
|
156 Subjects
|
118 Subjects
|
140 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Tenderness (Second Vacc)
|
121 Subjects
|
116 Subjects
|
97 Subjects
|
48 Subjects
|
88 Subjects
|
116 Subjects
|
47 Subjects
|
85 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Erythema (Second Vacc)
|
104 Subjects
|
114 Subjects
|
114 Subjects
|
71 Subjects
|
90 Subjects
|
104 Subjects
|
44 Subjects
|
94 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Induration (Second Vacc)
|
103 Subjects
|
105 Subjects
|
97 Subjects
|
63 Subjects
|
83 Subjects
|
94 Subjects
|
38 Subjects
|
79 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Swelling (Second Vacc)
|
64 Subjects
|
61 Subjects
|
54 Subjects
|
34 Subjects
|
50 Subjects
|
58 Subjects
|
21 Subjects
|
52 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Local (3rd N=181,179,185,183,181,180,177,179)
|
151 Subjects
|
147 Subjects
|
141 Subjects
|
122 Subjects
|
130 Subjects
|
152 Subjects
|
113 Subjects
|
128 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Tenderness (Third Vacc)
|
102 Subjects
|
98 Subjects
|
78 Subjects
|
47 Subjects
|
77 Subjects
|
111 Subjects
|
42 Subjects
|
66 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Erythema (Third Vacc)
|
110 Subjects
|
106 Subjects
|
112 Subjects
|
72 Subjects
|
94 Subjects
|
101 Subjects
|
63 Subjects
|
91 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Induration (Third Vacc)
|
97 Subjects
|
92 Subjects
|
92 Subjects
|
62 Subjects
|
79 Subjects
|
89 Subjects
|
55 Subjects
|
80 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Swelling (Third Vacc)
|
56 Subjects
|
56 Subjects
|
46 Subjects
|
35 Subjects
|
45 Subjects
|
58 Subjects
|
29 Subjects
|
47 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Local BoostN=155,162,169,168,168,165,162,159
|
131 Subjects
|
132 Subjects
|
149 Subjects
|
113 Subjects
|
127 Subjects
|
130 Subjects
|
133 Subjects
|
121 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Tenderness (Booster Vacc)
|
116 Subjects
|
107 Subjects
|
120 Subjects
|
77 Subjects
|
106 Subjects
|
112 Subjects
|
108 Subjects
|
92 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Erythema (Booster Vacc)
|
90 Subjects
|
101 Subjects
|
116 Subjects
|
67 Subjects
|
80 Subjects
|
85 Subjects
|
93 Subjects
|
81 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Induration (Booster Vacc)
|
73 Subjects
|
83 Subjects
|
95 Subjects
|
56 Subjects
|
66 Subjects
|
73 Subjects
|
62 Subjects
|
60 Subjects
|
|
Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Injection Site Swelling (Booster Vacc)
|
55 Subjects
|
59 Subjects
|
69 Subjects
|
31 Subjects
|
47 Subjects
|
52 Subjects
|
39 Subjects
|
47 Subjects
|
SECONDARY outcome
Timeframe: Day 1 through day 7 after each vaccination.Population: The analysis was performed on the safety population.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
Outcome measures
| Measure |
B+OMV (Group I)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=186 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=182 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=180 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=177 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=179 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Syst(BoosterN=155,162,169,169,168,165,164,159)
|
143 Subjects
|
144 Subjects
|
139 Subjects
|
118 Subjects
|
141 Subjects
|
142 Subjects
|
142 Subjects
|
137 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Fever ( ≥ 38.5°C ) (Third Vacc)
|
55 Subjects
|
53 Subjects
|
38 Subjects
|
16 Subjects
|
42 Subjects
|
54 Subjects
|
14 Subjects
|
20 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Antipyr. Med. Used (Third Vacc)
|
66 Subjects
|
60 Subjects
|
51 Subjects
|
26 Subjects
|
49 Subjects
|
63 Subjects
|
20 Subjects
|
153 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Change Eat. Habits (Booster Vacc)
|
74 Subjects
|
77 Subjects
|
79 Subjects
|
52 Subjects
|
70 Subjects
|
80 Subjects
|
59 Subjects
|
66 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Sleepiness (Booster Vacc)
|
76 Subjects
|
90 Subjects
|
90 Subjects
|
63 Subjects
|
86 Subjects
|
88 Subjects
|
85 Subjects
|
80 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Vomiting (Booster Vacc)
|
6 Subjects
|
11 Subjects
|
7 Subjects
|
7 Subjects
|
10 Subjects
|
9 Subjects
|
9 Subjects
|
20 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Diarrhea (Booster Vacc)
|
30 Subjects
|
34 Subjects
|
36 Subjects
|
43 Subjects
|
32 Subjects
|
30 Subjects
|
26 Subjects
|
30 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Irritability (Booster Vacc)
|
116 Subjects
|
111 Subjects
|
112 Subjects
|
86 Subjects
|
116 Subjects
|
115 Subjects
|
117 Subjects
|
96 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Unus Crying (Booster Vacc)
|
74 Subjects
|
64 Subjects
|
69 Subjects
|
46 Subjects
|
71 Subjects
|
82 Subjects
|
73 Subjects
|
50 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Rash (Booster Vacc)
|
5 Subjects
|
5 Subjects
|
8 Subjects
|
2 Subjects
|
8 Subjects
|
4 Subjects
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Fever ( ≥ 38.5°C ) (Booster Vacc)
|
81 Subjects
|
86 Subjects
|
64 Subjects
|
43 Subjects
|
78 Subjects
|
68 Subjects
|
84 Subjects
|
58 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Antipyr. Med. Used (Booster Vacc)
|
84 Subjects
|
82 Subjects
|
83 Subjects
|
42 Subjects
|
75 Subjects
|
80 Subjects
|
92 Subjects
|
128 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Systemic (First Vacc)
|
167 Subjects
|
173 Subjects
|
175 Subjects
|
152 Subjects
|
162 Subjects
|
171 Subjects
|
136 Subjects
|
150 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Change Eat. Habits (First Vacc)
|
76 Subjects
|
87 Subjects
|
84 Subjects
|
52 Subjects
|
84 Subjects
|
90 Subjects
|
41 Subjects
|
66 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Sleepiness (First Vacc)
|
120 Subjects
|
131 Subjects
|
119 Subjects
|
96 Subjects
|
117 Subjects
|
119 Subjects
|
92 Subjects
|
116 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Vomiting (First Vacc)
|
24 Subjects
|
18 Subjects
|
25 Subjects
|
15 Subjects
|
22 Subjects
|
26 Subjects
|
17 Subjects
|
22 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Diarrhea (First Vacc)
|
57 Subjects
|
55 Subjects
|
54 Subjects
|
31 Subjects
|
41 Subjects
|
49 Subjects
|
45 Subjects
|
41 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Irritability (First Vacc)
|
128 Subjects
|
124 Subjects
|
128 Subjects
|
99 Subjects
|
131 Subjects
|
131 Subjects
|
79 Subjects
|
97 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Unus Crying (First Vacc)
|
95 Subjects
|
101 Subjects
|
105 Subjects
|
61 Subjects
|
96 Subjects
|
108 Subjects
|
63 Subjects
|
74 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Rash (First Vacc)
|
6 Subjects
|
5 Subjects
|
5 Subjects
|
7 Subjects
|
10 Subjects
|
10 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Fever ( ≥ 38.5°C ) (First Vacc)
|
94 Subjects
|
91 Subjects
|
74 Subjects
|
24 Subjects
|
60 Subjects
|
76 Subjects
|
22 Subjects
|
46 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Antipyr. Med. Used (First Vacc)
|
102 Subjects
|
94 Subjects
|
92 Subjects
|
37 Subjects
|
74 Subjects
|
95 Subjects
|
32 Subjects
|
166 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Systemic (Second Vacc)
|
168 Subjects
|
158 Subjects
|
166 Subjects
|
144 Subjects
|
156 Subjects
|
158 Subjects
|
126 Subjects
|
147 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Change Eat. Habits (Second Vacc)
|
62 Subjects
|
55 Subjects
|
58 Subjects
|
53 Subjects
|
60 Subjects
|
80 Subjects
|
33 Subjects
|
54 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Sleepiness (Second Vacc)
|
105 Subjects
|
100 Subjects
|
102 Subjects
|
85 Subjects
|
92 Subjects
|
109 Subjects
|
75 Subjects
|
84 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Vomiting (Second Vacc)
|
18 Subjects
|
18 Subjects
|
14 Subjects
|
15 Subjects
|
17 Subjects
|
20 Subjects
|
14 Subjects
|
20 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Diarrhea (Second Vacc)
|
43 Subjects
|
41 Subjects
|
47 Subjects
|
40 Subjects
|
39 Subjects
|
47 Subjects
|
39 Subjects
|
40 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Irritability (Second Vacc)
|
130 Subjects
|
121 Subjects
|
124 Subjects
|
94 Subjects
|
117 Subjects
|
126 Subjects
|
82 Subjects
|
99 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Unus Crying (Second Vacc)
|
90 Subjects
|
90 Subjects
|
84 Subjects
|
70 Subjects
|
83 Subjects
|
99 Subjects
|
45 Subjects
|
71 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Rash (Second Vacc)
|
4 Subjects
|
9 Subjects
|
4 Subjects
|
5 Subjects
|
7 Subjects
|
4 Subjects
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Fever ( ≥ 38.5°C ) (Second Vacc)
|
90 Subjects
|
82 Subjects
|
77 Subjects
|
36 Subjects
|
74 Subjects
|
90 Subjects
|
30 Subjects
|
35 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Antipyr. Med. Used (Second Vacc)
|
100 Subjects
|
94 Subjects
|
83 Subjects
|
40 Subjects
|
79 Subjects
|
105 Subjects
|
39 Subjects
|
163 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Any Syst (3rdN=181,179,185,182,181,180,177,179)
|
146 Subjects
|
131 Subjects
|
132 Subjects
|
122 Subjects
|
141 Subjects
|
151 Subjects
|
106 Subjects
|
127 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Change Eat. Habits (Third Vacc)
|
49 Subjects
|
50 Subjects
|
42 Subjects
|
37 Subjects
|
45 Subjects
|
60 Subjects
|
22 Subjects
|
48 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Sleepiness (Third Vacc)
|
75 Subjects
|
67 Subjects
|
82 Subjects
|
64 Subjects
|
77 Subjects
|
79 Subjects
|
52 Subjects
|
75 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Vomiting (Third Vacc)
|
8 Subjects
|
18 Subjects
|
15 Subjects
|
12 Subjects
|
12 Subjects
|
13 Subjects
|
11 Subjects
|
20 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Diarrhea (Third Vacc)
|
33 Subjects
|
29 Subjects
|
39 Subjects
|
31 Subjects
|
34 Subjects
|
40 Subjects
|
19 Subjects
|
32 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Irritability (Third Vacc)
|
115 Subjects
|
97 Subjects
|
93 Subjects
|
74 Subjects
|
104 Subjects
|
115 Subjects
|
76 Subjects
|
84 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Unus Crying (Third Vacc)
|
76 Subjects
|
82 Subjects
|
62 Subjects
|
47 Subjects
|
69 Subjects
|
100 Subjects
|
38 Subjects
|
47 Subjects
|
|
Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Rash (Third Vacc)
|
1 Subjects
|
6 Subjects
|
4 Subjects
|
2 Subjects
|
8 Subjects
|
10 Subjects
|
6 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: Day 1 through day 7 after each vaccination.Population: The analysis was performed on the safety population.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
Outcome measures
| Measure |
B+OMV (Group I)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=189 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=187 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=187 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=185 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=184 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=183 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any SAE (Third Vacc)
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any AE (Day 1 to 7) (First Vacc)
|
55 Subjects
|
52 Subjects
|
51 Subjects
|
33 Subjects
|
35 Subjects
|
39 Subjects
|
27 Subjects
|
42 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
At least Possibly related AE (First Vacc)
|
48 Subjects
|
48 Subjects
|
43 Subjects
|
30 Subjects
|
27 Subjects
|
34 Subjects
|
22 Subjects
|
36 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any SAE (First Vacc)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any AE D1-7 2nd N=182,181,186,184,183,180,178,180
|
55 Subjects
|
53 Subjects
|
50 Subjects
|
41 Subjects
|
36 Subjects
|
47 Subjects
|
28 Subjects
|
45 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
At least Possibly related AE (Second Vaccination)
|
49 Subjects
|
45 Subjects
|
45 Subjects
|
36 Subjects
|
33 Subjects
|
41 Subjects
|
26 Subjects
|
39 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any SAE (Second Vacc)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any AE D1-7 3rd N=182,181,186,184,182,180,177,179
|
40 Subjects
|
59 Subjects
|
49 Subjects
|
35 Subjects
|
31 Subjects
|
45 Subjects
|
35 Subjects
|
39 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
At least Possibly related AE (Third Vacc)
|
34 Subjects
|
52 Subjects
|
45 Subjects
|
29 Subjects
|
23 Subjects
|
37 Subjects
|
29 Subjects
|
36 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any AE D 1-7Boos N=155,163,169,169,168,165,165,161
|
35 Subjects
|
46 Subjects
|
56 Subjects
|
35 Subjects
|
29 Subjects
|
30 Subjects
|
37 Subjects
|
30 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
At least Possibly related AE (Booster Vacc)
|
28 Subjects
|
41 Subjects
|
48 Subjects
|
23 Subjects
|
23 Subjects
|
26 Subjects
|
30 Subjects
|
25 Subjects
|
|
Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Any SAE (Booster Vacc)
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Overall study period.Population: The analysis was performed on the safety population.
To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
Outcome measures
| Measure |
B+OMV (Group I)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
n=184 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
n=189 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
n=187 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
n=187 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
n=185 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
n=184 Participants
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
n=183 Participants
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
AE Leading to Premature Withdrawal-Primary Vacc
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
Treatment Emergent SAEs - Primary Vacc
|
16 Subjects
|
20 Subjects
|
12 Subjects
|
20 Subjects
|
13 Subjects
|
16 Subjects
|
11 Subjects
|
15 Subjects
|
|
Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
Tr E SAE Boost (N=155,163,169,169,168,165,165,161)
|
14 Subjects
|
7 Subjects
|
12 Subjects
|
5 Subjects
|
15 Subjects
|
9 Subjects
|
9 Subjects
|
16 Subjects
|
SECONDARY outcome
Timeframe: Day 1 through day 7 at 13 months age.Population: The analysis was performed on the safety population.
To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Outcome measures
| Measure |
B+OMV (Group I)
n=156 Participants
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+1/4 OMV (Group III)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B (Group IV)
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
½ (B+OMV) (Group V)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
PH2 B+OMV (Group VI)
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
MenC (Group VII)
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
|
Par+B+OMV (Group VIII)
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Diarrhea
|
18 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Injection Site Tenderness
|
92 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Injection Site Erythema
|
84 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Injection Site Induration
|
59 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Injection Site Swelling
|
35 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Change Eat. Habits (N=155)
|
43 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Sleepiness
|
57 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Vomiting
|
8 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Irritability
|
75 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Unus Crying
|
37 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Rash
|
4 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Fever ( ≥ 38.5°C ) (N=158)
|
35 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Antipyr. Med. Used (N=157)
|
47 Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
MenC (Group VII)
Serious events: 11 serious events
Other events: 175 other events
Deaths: 0 deaths
Par+B+OMV (Group VIII)
Serious events: 15 serious events
Other events: 175 other events
Deaths: 0 deaths
B+OMV (Group I) Booster Phase
Serious events: 14 serious events
Other events: 151 other events
Deaths: 0 deaths
B+½ OMV (Group II) Booster Phase
Serious events: 7 serious events
Other events: 159 other events
Deaths: 0 deaths
B+1/4 OMV (Group III) Booster Phase
Serious events: 12 serious events
Other events: 162 other events
Deaths: 0 deaths
B (Group IV) Booster Phase
Serious events: 5 serious events
Other events: 152 other events
Deaths: 0 deaths
½ (B+OMV) (Group V) Booster Phase
Serious events: 15 serious events
Other events: 154 other events
Deaths: 0 deaths
PH2 B+OMV (Group VI) Booster Phase
Serious events: 9 serious events
Other events: 156 other events
Deaths: 0 deaths
MenC (Group VII) Booster Phase
Serious events: 9 serious events
Other events: 155 other events
Deaths: 0 deaths
Par+B+OMV (Group VIII) Booster Phase
Serious events: 14 serious events
Other events: 150 other events
Deaths: 0 deaths
B+OMV (Group I)
Serious events: 16 serious events
Other events: 181 other events
Deaths: 0 deaths
B+½ OMV (Group II)
Serious events: 20 serious events
Other events: 183 other events
Deaths: 0 deaths
B+1/4 OMV (Group III)
Serious events: 12 serious events
Other events: 186 other events
Deaths: 0 deaths
B (Group IV)
Serious events: 20 serious events
Other events: 183 other events
Deaths: 0 deaths
½ (B+OMV) (Group V)
Serious events: 13 serious events
Other events: 180 other events
Deaths: 0 deaths
PH2 B+OMV (Group VI)
Serious events: 16 serious events
Other events: 180 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenC (Group VII)
n=184 participants at risk
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
Par+B+OMV (Group VIII)
n=183 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+OMV (Group I) Booster Phase
n=155 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II) Booster Phase
n=163 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
B+1/4 OMV (Group III) Booster Phase
n=169 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
B (Group IV) Booster Phase
n=169 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
½ (B+OMV) (Group V) Booster Phase
n=168 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
PH2 B+OMV (Group VI) Booster Phase
n=165 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
MenC (Group VII) Booster Phase
n=165 participants at risk
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to include Booster Phase.
|
Par+B+OMV (Group VIII) Booster Phase
n=161 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
|
B+OMV (Group I)
n=184 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+½ OMV (Group II)
n=184 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+1/4 OMV (Group III)
n=189 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B (Group IV)
n=187 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting..
|
½ (B+OMV) (Group V)
n=187 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
PH2 B+OMV (Group VI)
n=185 participants at risk
SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Cleft palate repair
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Pyrexia
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Injection site erythema
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Congenital megacolon
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.9%
3/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bronchitis
|
1.1%
2/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.4%
4/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.8%
3/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.1%
4/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.1%
4/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bronchopneumonia
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.3%
2/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.9%
3/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.8%
3/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Oral candidiasis
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Oral herpes
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Otitis media acute
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pneumonia
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pyelonephritis
|
1.1%
2/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.62%
1/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Varicella
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Ear infection
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.60%
1/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.65%
1/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.55%
1/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.53%
1/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.59%
1/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.61%
1/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Investigations
Acoustic Stimulation Tests
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.54%
1/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
Other adverse events
| Measure |
MenC (Group VII)
n=184 participants at risk
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
Par+B+OMV (Group VIII)
n=183 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+OMV (Group I) Booster Phase
n=155 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
|
B+½ OMV (Group II) Booster Phase
n=163 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
B+1/4 OMV (Group III) Booster Phase
n=169 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
B (Group IV) Booster Phase
n=169 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
½ (B+OMV) (Group V) Booster Phase
n=168 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
PH2 B+OMV (Group VI) Booster Phase
n=165 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to include Booster Phase.
|
MenC (Group VII) Booster Phase
n=165 participants at risk
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.
Group defined to include Booster Phase.
|
Par+B+OMV (Group VIII) Booster Phase
n=161 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
|
B+OMV (Group I)
n=184 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+½ OMV (Group II)
n=184 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B+1/4 OMV (Group III)
n=189 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
B (Group IV)
n=187 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting..
|
½ (B+OMV) (Group V)
n=187 participants at risk
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
PH2 B+OMV (Group VI)
n=185 participants at risk
SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Group defined to be applicable Prior to Booster Phase for AEs reporting.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
12/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.5%
10/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
5/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.4%
12/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.3%
9/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
8/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.1%
10/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.0%
22/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.4%
21/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
9/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.2%
19/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.0%
13/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.3%
19/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Nervous system disorders
Somnolence
|
61.4%
113/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
73.2%
134/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
49.0%
76/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
55.2%
90/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
53.3%
90/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
37.3%
63/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
51.2%
86/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
53.3%
88/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
60.6%
100/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
49.7%
80/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
78.8%
145/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
81.0%
149/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
77.2%
146/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.1%
131/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
75.9%
142/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
77.3%
143/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Crying
|
47.3%
87/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
61.2%
112/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
47.7%
74/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
39.3%
64/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
40.8%
69/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
27.2%
46/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.3%
71/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
49.7%
82/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
51.5%
85/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
31.1%
50/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
66.3%
122/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
73.4%
135/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
72.5%
137/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
52.9%
99/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
66.8%
125/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
76.2%
141/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Injection site erythema
|
64.7%
119/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
72.1%
132/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
62.6%
97/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
65.6%
107/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
71.0%
120/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
49.1%
83/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
53.0%
89/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
58.2%
96/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
66.7%
110/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
54.7%
88/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
82.1%
151/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
81.5%
150/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
82.0%
155/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.6%
132/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.1%
131/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
81.1%
150/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Injection site induration
|
66.3%
122/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
68.9%
126/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
52.3%
81/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
55.2%
90/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
62.1%
105/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.0%
71/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
45.2%
76/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
49.1%
81/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
58.8%
97/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
43.5%
70/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
76.6%
141/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
75.5%
139/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
74.6%
141/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
67.4%
126/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
69.5%
130/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.3%
130/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Injection site pain
|
57.1%
105/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
65.0%
119/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
78.1%
121/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
67.5%
110/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
74.6%
126/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
54.4%
92/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
66.1%
111/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.3%
116/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
75.8%
125/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
60.2%
97/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
81.5%
150/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
85.3%
157/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
73.5%
139/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
54.0%
101/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
70.1%
131/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
82.2%
152/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Pyrexia
|
33.7%
62/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.6%
78/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
55.5%
86/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
57.7%
94/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
41.4%
70/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
29.0%
49/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
50.6%
85/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
43.6%
72/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
55.8%
92/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
36.6%
59/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
73.9%
136/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
69.0%
127/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
64.6%
122/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
38.0%
71/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
61.0%
114/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
68.1%
126/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
General disorders
Injection site swelling
|
40.8%
75/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.1%
77/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
36.8%
57/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
38.7%
63/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
45.0%
76/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
27.2%
46/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
31.5%
53/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
34.5%
57/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
39.4%
65/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
31.1%
50/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
52.7%
97/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
51.1%
94/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
54.5%
103/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.8%
80/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
47.1%
88/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
54.1%
100/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Psychiatric disorders
Eating disorder
|
34.2%
63/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
50.8%
93/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
47.7%
74/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
47.2%
77/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
46.7%
79/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
30.8%
52/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
41.7%
70/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
48.5%
80/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
43.6%
72/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
41.0%
66/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
57.1%
105/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
57.6%
106/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
55.0%
104/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
44.9%
84/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
59.9%
112/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
64.3%
119/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Psychiatric disorders
Irritability
|
65.8%
121/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
74.9%
137/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
74.8%
116/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
68.1%
111/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
66.3%
112/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
50.9%
86/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
69.0%
116/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
69.7%
115/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
76.4%
126/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
59.6%
96/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
85.3%
157/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
86.4%
159/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
82.0%
155/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
74.3%
139/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
80.7%
151/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
82.7%
153/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.2%
74/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
39.9%
73/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
20.0%
31/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
22.7%
37/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
23.1%
39/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
27.8%
47/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
20.2%
34/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
18.8%
31/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
24.2%
40/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
21.1%
34/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
45.7%
84/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
47.3%
87/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.3%
80/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
35.8%
67/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
42.8%
80/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
43.8%
81/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
34/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
25.1%
46/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.9%
6/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.0%
13/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.1%
7/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.1%
7/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.0%
10/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.1%
10/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
15/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.4%
20/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
20.7%
38/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
20.1%
37/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
22.2%
42/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
17.1%
32/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
19.3%
36/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
23.2%
43/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
13/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.9%
9/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
10/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
7/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
6/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
16/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.4%
19/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.2%
8/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
6/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
9/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.3%
12/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.2%
15/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.8%
18/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.9%
15/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.6%
18/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.8%
24/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
14.1%
26/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Bronchitis
|
18.5%
34/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
19.1%
35/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
16.1%
25/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.0%
18/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
14.8%
25/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
16.6%
28/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
16.7%
28/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.5%
19/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
21.2%
35/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.6%
17/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
18.5%
34/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
18.5%
34/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
21.2%
40/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
16.6%
31/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
16.6%
31/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
23.2%
43/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Conjunctivitis
|
5.4%
10/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.3%
17/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.5%
7/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.7%
13/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
8/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.2%
7/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.2%
10/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.6%
14/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.1%
13/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.4%
14/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.0%
13/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.0%
15/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.9%
22/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Ear infection
|
4.9%
9/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.8%
7/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.2%
8/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.5%
4/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.2%
2/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
9/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.2%
7/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.7%
11/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.5%
4/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
10/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.3%
10/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
6/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
7/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
12/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Exanthema subitum
|
10.9%
20/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.0%
11/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.9%
6/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.7%
8/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.2%
7/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.2%
10/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.9%
9/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.8%
18/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.0%
17/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
17/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.2%
19/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.0%
13/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
7/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.4%
8/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
5/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.5%
4/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.7%
8/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.1%
12/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
15/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.5%
9/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
10/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.0%
11/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
6/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
9/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.2%
6/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.0%
13/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
16/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.4%
19/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.7%
15/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.1%
10/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.7%
18/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.3%
14/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
15/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.5%
14/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.9%
20/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.0%
22/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
13.2%
25/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
17/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.2%
19/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
13.0%
24/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Pharyngitis
|
9.8%
18/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.4%
19/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.1%
11/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.8%
16/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.7%
13/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.3%
14/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
13.1%
22/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.1%
15/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.7%
16/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.3%
15/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.4%
21/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.8%
18/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.9%
15/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.2%
21/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
13.4%
25/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.1%
15/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Rhinitis
|
10.9%
20/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.6%
12/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.5%
7/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.5%
9/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.7%
8/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
11/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.0%
10/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
8/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
6/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.4%
21/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.6%
14/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.3%
12/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.2%
19/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.2%
21/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
14.1%
26/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Tonsillitis
|
2.7%
5/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.2%
4/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.9%
6/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.1%
10/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.4%
4/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.7%
8/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.0%
5/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
8/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.6%
9/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.3%
6/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.6%
3/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.4%
12/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
7/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
9/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.9%
9/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.2%
8/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
7/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.7%
8/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.3%
9/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.2%
7/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.5%
9/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.8%
8/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.1%
5/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.1%
13/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.1%
13/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.3%
10/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.3%
10/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
4.3%
8/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.5%
12/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Varicella
|
2.7%
5/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
0.00%
0/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.4%
10/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
1.1%
2/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.7%
7/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
2.7%
5/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
|
Infections and infestations
Viral infection
|
8.7%
16/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
11.5%
21/183 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.7%
12/155 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
8.6%
14/163 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
3.6%
6/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.5%
16/169 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.7%
18/168 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
5.5%
9/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
7.3%
12/165 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
6.8%
11/161 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
10.3%
19/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
14.7%
27/184 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.2%
23/189 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.8%
24/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
12.8%
24/187 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
9.2%
17/185 • All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60