Trial Outcomes & Findings for Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years) (NCT NCT00972816)
NCT ID: NCT00972816
Last Updated: 2016-04-14
Results Overview
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1357 participants
Primary outcome timeframe
Day 22, Day 29, Day 43, Day 202 and Day 387
Results posted on
2016-04-14
Participant Flow
36 centers in the U.S., of which 34 centers enrolled subjects.
Participant milestones
| Measure |
3.75_(50) MF59
3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
7.5_(0) MF59
7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
7.5_(50)MF59
7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
7.5_(100)MF59
7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
|
15_(0) MF59
15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
15_(50) MF59
15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
15_(100) MF59
15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
|
30_(0) MF59
30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
173
|
169
|
169
|
169
|
169
|
169
|
169
|
170
|
|
Overall Study
COMPLETED
|
156
|
158
|
160
|
161
|
157
|
158
|
159
|
161
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
9
|
8
|
12
|
11
|
10
|
9
|
Reasons for withdrawal
| Measure |
3.75_(50) MF59
3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
7.5_(0) MF59
7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
7.5_(50)MF59
7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
7.5_(100)MF59
7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
|
15_(0) MF59
15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
15_(50) MF59
15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
|
15_(100) MF59
15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
|
30_(0) MF59
30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
3
|
0
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
7
|
5
|
11
|
10
|
7
|
7
|
|
Overall Study
Inappropriate enrolment
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Unable to classify
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Baseline characteristics by cohort
| Measure |
3.75_(50)MF59
n=173 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=169 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=169 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=169 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=169 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=169 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=169 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=170 Participants
1 dose of 30 µg A/H1N1
|
Total
n=1357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
5.6 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
5.2 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
5.5 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
5.9 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 1.7 • n=31 Participants
|
5.5 years
STANDARD_DEVIATION 1.7 • n=30 Participants
|
5.5 years
STANDARD_DEVIATION 1.7 • n=3 Participants
|
5.5 years
STANDARD_DEVIATION 1.7 • n=6 Participants
|
5.5 years
STANDARD_DEVIATION 1.7 • n=114 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
79 Participants
n=31 Participants
|
80 Participants
n=30 Participants
|
75 Participants
n=3 Participants
|
83 Participants
n=6 Participants
|
652 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
90 Participants
n=31 Participants
|
89 Participants
n=30 Participants
|
94 Participants
n=3 Participants
|
87 Participants
n=6 Participants
|
705 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Day 22, Day 29, Day 43, Day 202 and Day 387Population: The analysis was performed on per protocol set (PPS) population
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 (Baseline)
|
11 percentage of subjects
Interval 6.0 to 17.0
|
9 percentage of subjects
Interval 5.0 to 15.0
|
13 percentage of subjects
Interval 8.0 to 19.0
|
11 percentage of subjects
Interval 6.0 to 170.0
|
15 percentage of subjects
Interval 10.0 to 22.0
|
9 percentage of subjects
Interval 5.0 to 15.0
|
8 percentage of subjects
Interval 4.0 to 13.0
|
12 percentage of subjects
Interval 8.0 to 19.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 day 22
|
84 percentage of subjects
Interval 77.0 to 89.0
|
48 percentage of subjects
Interval 40.0 to 56.0
|
81 percentage of subjects
Interval 74.0 to 87.0
|
91 percentage of subjects
Interval 85.0 to 95.0
|
61 percentage of subjects
Interval 52.0 to 68.0
|
82 percentage of subjects
Interval 75.0 to 88.0
|
94 percentage of subjects
Interval 89.0 to 97.0
|
65 percentage of subjects
Interval 57.0 to 73.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Seroconversion day 22
|
82 percentage of subjects
Interval 74.0 to 87.0
|
46 percentage of subjects
Interval 38.0 to 54.0
|
78 percentage of subjects
Interval 70.0 to 84.0
|
88 percentage of subjects
Interval 82.0 to 93.0
|
58 percentage of subjects
Interval 50.0 to 66.0
|
82 percentage of subjects
Interval 75.0 to 87.0
|
92 percentage of subjects
Interval 86.0 to 95.0
|
60 percentage of subjects
Interval 52.0 to 68.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 (Day 29)
|
99 percentage of subjects
Interval 96.0 to 100.0
|
79 percentage of subjects
Interval 71.0 to 85.0
|
100 percentage of subjects
Interval 98.0 to 100.0
|
99 percentage of subjects
Interval 95.0 to 100.0
|
88 percentage of subjects
Interval 82.0 to 93.0
|
100 percentage of subjects
Interval 98.0 to 100.0
|
100 percentage of subjects
Interval 97.0 to 100.0
|
97 percentage of subjects
Interval 92.0 to 99.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Seroconversion (Day 29)
|
99 percentage of subjects
Interval 95.0 to 100.0
|
78 percentage of subjects
Interval 70.0 to 84.0
|
99 percentage of subjects
Interval 95.0 to 100.0
|
99 percentage of subjects
Interval 95.0 to 100.0
|
87 percentage of subjects
Interval 81.0 to 92.0
|
100 percentage of subjects
Interval 98.0 to 100.0
|
100 percentage of subjects
Interval 97.0 to 100.0
|
94 percentage of subjects
Interval 88.0 to 97.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 day 43
|
99 percentage of subjects
Interval 96.0 to 100.0
|
79 percentage of subjects
Interval 72.0 to 85.0
|
100 percentage of subjects
Interval 98.0 to 100.0
|
99 percentage of subjects
Interval 95.0 to 100.0
|
87 percentage of subjects
Interval 81.0 to 92.0
|
99 percentage of subjects
Interval 97.0 to 100.0
|
100 percentage of subjects
Interval 98.0 to 100.0
|
92 percentage of subjects
Interval 86.0 to 95.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 day 202 (N=82,85,84,84,86,87,82,79)
|
95 percentage of subjects
Interval 88.0 to 99.0
|
65 percentage of subjects
Interval 54.0 to 75.0
|
93 percentage of subjects
Interval 85.0 to 97.0
|
95 percentage of subjects
Interval 88.0 to 99.0
|
74 percentage of subjects
Interval 64.0 to 83.0
|
95 percentage of subjects
Interval 89.0 to 99.0
|
95 percentage of subjects
Interval 88.0 to 99.0
|
81 percentage of subjects
Interval 71.0 to 89.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Seroconversion day 202 (N=82,85,84,84,86,87,82,79)
|
83 percentage of subjects
Interval 73.0 to 90.0
|
55 percentage of subjects
Interval 44.0 to 66.0
|
83 percentage of subjects
Interval 74.0 to 91.0
|
83 percentage of subjects
Interval 74.0 to 91.0
|
63 percentage of subjects
Interval 52.0 to 73.0
|
90 percentage of subjects
Interval 81.0 to 95.0
|
90 percentage of subjects
Interval 82.0 to 96.0
|
66 percentage of subjects
Interval 54.0 to 76.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI titer ≥1:40 day 387 (N=55,63,61,58,61,65,59,63)
|
80 percentage of subjects
Interval 67.0 to 90.0
|
56 percentage of subjects
Interval 42.0 to 68.0
|
75 percentage of subjects
Interval 63.0 to 86.0
|
88 percentage of subjects
Interval 77.0 to 95.0
|
49 percentage of subjects
Interval 36.0 to 62.0
|
78 percentage of subjects
Interval 67.0 to 88.0
|
81 percentage of subjects
Interval 69.0 to 90.0
|
65 percentage of subjects
Interval 52.0 to 77.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Seroconversion day 387 (N=55,63,61,58,61,65,59,63)
|
65 percentage of subjects
Interval 51.0 to 78.0
|
49 percentage of subjects
Interval 36.0 to 62.0
|
69 percentage of subjects
Interval 56.0 to 80.0
|
78 percentage of subjects
Interval 65.0 to 87.0
|
44 percentage of subjects
Interval 32.0 to 58.0
|
75 percentage of subjects
Interval 63.0 to 85.0
|
71 percentage of subjects
Interval 58.0 to 82.0
|
51 percentage of subjects
Interval 38.0 to 64.0
|
|
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Seroconversion day 43
|
98 percentage of subjects
Interval 94.0 to 100.0
|
78 percentage of subjects
Interval 70.0 to 84.0
|
97 percentage of subjects
Interval 93.0 to 99.0
|
97 percentage of subjects
Interval 94.0 to 99.0
|
85 percentage of subjects
Interval 78.0 to 90.0
|
99 percentage of subjects
Interval 95.0 to 100.0
|
99 percentage of subjects
Interval 96.0 to 100.0
|
88 percentage of subjects
Interval 82.0 to 93.0
|
SECONDARY outcome
Timeframe: Day 22, Day 29, Day 43, Day 202 and Day 387Population: The analysis was performed on per protocol set (PPS) population
Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMTs day 387 (N=55,63,61,58,61,65,59,63)
|
54 Titers
Interval 37.0 to 78.0
|
28 Titers
Interval 20.0 to 40.0
|
57 Titers
Interval 40.0 to 82.0
|
70 Titers
Interval 49.0 to 102.0
|
30 Titers
Interval 21.0 to 42.0
|
59 Titers
Interval 41.0 to 83.0
|
63 Titers
Interval 44.0 to 90.0
|
45 Titers
Interval 31.0 to 64.0
|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMT Baseline
|
8.5 Titers
Interval 7.0 to 10.0
|
7.3 Titers
Interval 6.0 to 8.8
|
8.7 Titers
Interval 7.2 to 11.0
|
8.7 Titers
Interval 6.7 to 9.9
|
9.1 Titers
Interval 7.5 to 11.0
|
7.5 Titers
Interval 6.2 to 9.1
|
7 Titers
Interval 5.8 to 8.4
|
9.1 Titers
Interval 7.5 to 11.0
|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMTs day 22
|
107 Titers
Interval 78.0 to 148.0
|
27 Titers
Interval 20.0 to 37.0
|
88 Titers
Interval 64.0 to 121.0
|
163 Titers
Interval 118.0 to 223.0
|
49 Titers
Interval 36.0 to 68.0
|
106 Titers
Interval 77.0 to 145.0
|
160 Titers
Interval 116.0 to 220.0
|
62 Titers
Interval 45.0 to 85.0
|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMT Day 29
|
747 Titers
Interval 588.0 to 950.0
|
138 Titers
Interval 109.0 to 174.0
|
685 Titers
Interval 542.0 to 866.0
|
984 Titers
Interval 775.0 to 1249.0
|
214 Titers
Interval 169.0 to 271.0
|
761 Titers
Interval 600.0 to 966.0
|
1070 Titers
Interval 841.0 to 1360.0
|
297 Titers
Interval 235.0 to 377.0
|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMTs day 43
|
560 Titers
Interval 450.0 to 699.0
|
113 Titers
Interval 91.0 to 140.0
|
480 Titers
Interval 386.0 to 597.0
|
637 Titers
Interval 511.0 to 793.0
|
174 Titers
Interval 140.0 to 217.0
|
524 Titers
Interval 420.0 to 652.0
|
778 Titers
Interval 625.0 to 969.0
|
223 Titers
Interval 179.0 to 278.0
|
|
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
GMTs day 202 (N=143,149,149,146,147,147,144,144)
|
117 Titers
Interval 88.0 to 157.0
|
45 Titers
Interval 34.0 to 59.0
|
107 Titers
Interval 80.0 to 144.0
|
132 Titers
Interval 99.0 to 177.0
|
55 Titers
Interval 41.0 to 74.0
|
134 Titers
Interval 100.0 to 179.0
|
131 Titers
Interval 97.0 to 176.0
|
81 Titers
Interval 60.0 to 109.0
|
SECONDARY outcome
Timeframe: Day 22, Day 29, Day 43Population: The analysis was done on PPS population
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is \> 40%.The percentage of subjects achieving an HI titer ≥ 40 is \> 70% and The GMR is \> 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 22/Day 1)with seasonal flu vac
|
73 percentage of Subjects
Interval 39.0 to 94.0
|
22 percentage of Subjects
Interval 3.0 to 60.0
|
83 percentage of Subjects
Interval 36.0 to 100.0
|
100 percentage of Subjects
Interval 63.0 to 100.0
|
44 percentage of Subjects
Interval 14.0 to 79.0
|
73 percentage of Subjects
Interval 39.0 to 94.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
71 percentage of Subjects
Interval 29.0 to 96.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 29/Day 1)with seasonal flu vac
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
67 percentage of Subjects
Interval 30.0 to 93.0
|
83 percentage of Subjects
Interval 36.0 to 100.0
|
100 percentage of Subjects
Interval 59.0 to 100.0
|
67 percentage of Subjects
Interval 30.0 to 93.0
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
100 percentage of Subjects
Interval 48.0 to 100.0
|
83 percentage of Subjects
Interval 36.0 to 100.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 43/Day 1)with seasonal flu va
|
91 percentage of Subjects
Interval 59.0 to 100.0
|
78 percentage of Subjects
Interval 40.0 to 97.0
|
67 percentage of Subjects
Interval 22.0 to 96.0
|
88 percentage of Subjects
Interval 47.0 to 100.0
|
78 percentage of Subjects
Interval 40.0 to 97.0
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
86 percentage of Subjects
Interval 42.0 to 100.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 1)_ with seasonal flu vac
|
18 percentage of Subjects
Interval 2.0 to 52.0
|
22 percentage of Subjects
Interval 3.0 to 60.0
|
50 percentage of Subjects
Interval 12.0 to 88.0
|
38 percentage of Subjects
Interval 9.0 to 76.0
|
0 percentage of Subjects
Interval 0.0 to 34.0
|
9 percentage of Subjects
Interval 0.0 to 41.0
|
17 percentage of Subjects
Interval 0.0 to 64.0
|
0 percentage of Subjects
Interval 0.0 to 41.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 22)_ with seasonal flu vac
|
73 percentage of Subjects
Interval 39.0 to 94.0
|
33 percentage of Subjects
Interval 7.0 to 70.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
100 percentage of Subjects
Interval 63.0 to 100.0
|
44 percentage of Subjects
Interval 14.0 to 79.0
|
73 percentage of Subjects
Interval 39.0 to 94.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
71 percentage of Subjects
Interval 29.0 to 96.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 29)_ with seasonal flu vac
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
67 percentage of Subjects
Interval 30.0 to 93.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
100 percentage of Subjects
Interval 59.0 to 100.0
|
67 percentage of Subjects
Interval 30.0 to 93.0
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
100 percentage of Subjects
Interval 48.0 to 100.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 43)_ with seasonal flu vac
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
78 percentage of Subjects
Interval 40.0 to 97.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
100 percentage of Subjects
Interval 63.0 to 100.0
|
78 percentage of Subjects
Interval 40.0 to 97.0
|
100 percentage of Subjects
Interval 72.0 to 100.0
|
100 percentage of Subjects
Interval 54.0 to 100.0
|
86 percentage of Subjects
Interval 42.0 to 100.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 22/Day 1)without flu vac
|
82 percentage of Subjects
Interval 75.0 to 88.0
|
47 percentage of Subjects
Interval 39.0 to 55.0
|
77 percentage of Subjects
Interval 70.0 to 84.0
|
88 percentage of Subjects
Interval 81.0 to 93.0
|
59 percentage of Subjects
Interval 50.0 to 67.0
|
82 percentage of Subjects
Interval 75.0 to 88.0
|
91 percentage of Subjects
Interval 86.0 to 95.0
|
60 percentage of Subjects
Interval 51.0 to 68.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 29/Day 1)without flu vac
|
98 percentage of Subjects
Interval 95.0 to 100.0
|
79 percentage of Subjects
Interval 71.0 to 85.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
88 percentage of Subjects
Interval 82.0 to 93.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
94 percentage of Subjects
Interval 89.0 to 97.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Seroconversion (Day 43/Day 1)without flu vac
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
78 percentage of Subjects
Interval 70.0 to 84.0
|
98 percentage of Subjects
Interval 94.0 to 100.0
|
98 percentage of Subjects
Interval 94.0 to 100.0
|
85 percentage of Subjects
Interval 78.0 to 90.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
88 percentage of Subjects
Interval 82.0 to 93.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 1) without flu vac
|
10 percentage of Subjects
Interval 6.0 to 16.0
|
8 percentage of Subjects
Interval 4.0 to 14.0
|
11 percentage of Subjects
Interval 7.0 to 18.0
|
9 percentage of Subjects
Interval 5.0 to 15.0
|
16 percentage of Subjects
Interval 11.0 to 23.0
|
9 percentage of Subjects
Interval 5.0 to 15.0
|
7 percentage of Subjects
Interval 4.0 to 13.0
|
13 percentage of Subjects
Interval 8.0 to 20.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 22)without flu vac
|
84 percentage of Subjects
Interval 77.0 to 90.0
|
49 percentage of Subjects
Interval 41.0 to 57.0
|
80 percentage of Subjects
Interval 73.0 to 86.0
|
91 percentage of Subjects
Interval 85.0 to 95.0
|
62 percentage of Subjects
Interval 53.0 to 70.0
|
83 percentage of Subjects
Interval 76.0 to 89.0
|
93 percentage of Subjects
Interval 88.0 to 97.0
|
65 percentage of Subjects
Interval 57.0 to 73.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 29) without flu vac
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
79 percentage of Subjects
Interval 72.0 to 86.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
90 percentage of Subjects
Interval 84.0 to 94.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
96 percentage of Subjects
Interval 92.0 to 99.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI titer ≥1:40 (Day 43) without flu vac
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
79 percentage of Subjects
Interval 71.0 to 85.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
88 percentage of Subjects
Interval 81.0 to 93.0
|
99 percentage of Subjects
Interval 96.0 to 100.0
|
100 percentage of Subjects
Interval 98.0 to 100.0
|
92 percentage of Subjects
Interval 86.0 to 96.0
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 29, Day 43Population: The analysis was done on PPS population.
Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively. Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively. PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 43_ without seasonal flu vaccination
|
600 Titers
Interval 477.0 to 753.0
|
115 Titers
Interval 92.0 to 144.0
|
477 Titers
Interval 381.0 to 596.0
|
643 Titers
Interval 514.0 to 805.0
|
182 Titers
Interval 145.0 to 228.0
|
520 Titers
Interval 414.0 to 653.0
|
770 Titers
Interval 615.0 to 963.0
|
224 Titers
Interval 179.0 to 281.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 1_with seasonal flu vaccination
|
6.22 Titers
Interval 2.16 to 18.0
|
12 Titers
Interval 3.63 to 42.0
|
22 Titers
Interval 5.54 to 90.0
|
15 Titers
Interval 4.5 to 47.0
|
5.42 Titers
Interval 1.75 to 17.0
|
5.99 Titers
Interval 2.16 to 17.0
|
15 Titers
Interval 3.94 to 565.0
|
9.36 Titers
Interval 2.69 to 33.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 22_ with seasonal flu vaccination
|
36 Titers
Interval 9.11 to 146.0
|
44 Titers
Interval 8.93 to 217.0
|
196 Titers
Interval 32.0 to 1213.0
|
209 Titers
Interval 45.0 to 976.0
|
48 Titers
Interval 11.0 to 210.0
|
44 Titers
Interval 11.0 to 166.0
|
345 Titers
Interval 61.0 to 1961.0
|
111 Titers
Interval 22.0 to 567.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 29_ with seasonal flu vaccination
|
278 Titers
Interval 90.0 to 856.0
|
171 Titers
Interval 47.0 to 625.0
|
785 Titers
Interval 178.0 to 3450.0
|
1186 Titers
Interval 317.0 to 4440.0
|
137 Titers
Interval 41.0 to 457.0
|
670 Titers
Interval 226.0 to 1988.0
|
771 Titers
Interval 164.0 to 3628.0
|
184 Titers
Interval 43.0 to 791.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 43_ with seasonal flu vaccination
|
260 Titers
Interval 102.0 to 665.0
|
182 Titers
Interval 62.0 to 537.0
|
503 Titers
Interval 146.0 to 1729.0
|
594 Titers
Interval 209.0 to 1687.0
|
81 Titers
Interval 30.0 to 221.0
|
663 Titers
Interval 268.0 to 1639.0
|
1035 Titers
Interval 319.0 to 3363.0
|
228 Titers
Interval 75.0 to 689.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 1_without seasonal flu vaccination
|
8.54 Titers
Interval 7.03 to 10.0
|
7.08 Titers
Interval 5.84 to 8.59
|
8.3 Titers
Interval 6.86 to 10.0
|
7.76 Titers
Interval 6.41 to 9.41
|
9.35 Titers
Interval 7.71 to 11.0
|
7.47 Titers
Interval 6.15 to 9.08
|
6.8 Titers
Interval 5.61 to 8.24
|
9.1 Titers
Interval 7.51 to 11.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 22_ without seasonal flu vaccination
|
115 Titers
Interval 83.0 to 161.0
|
28 Titers
Interval 20.0 to 38.0
|
85 Titers
Interval 61.0 to 117.0
|
159 Titers
Interval 115.0 to 220.0
|
52 Titers
Interval 38.0 to 72.0
|
109 Titers
Interval 79.0 to 152.0
|
158 Titers
Interval 114.0 to 218.0
|
62 Titers
Interval 45.0 to 85.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 29_ without seasonal flu vaccination
|
810 Titers
Interval 633.0 to 1037.0
|
144 Titers
Interval 113.0 to 183.0
|
669 Titers
Interval 527.0 to 849.0
|
968 Titers
Interval 760.0 to 1232.0
|
228 Titers
Interval 179.0 to 291.0
|
756 Titers
Interval 591.0 to 966.0
|
1080 Titers
Interval 847.0 to 1377.0
|
297 Titers
Interval 233.0 to 377.0
|
SECONDARY outcome
Timeframe: Day 22, Day 29 and Day 43Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Subgroups with baseline HI titer \< 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively. Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 22/Day 1)_baseline HI < 1:10
|
81 percentage of Subjects
Interval 72.0 to 88.0
|
39 percentage of Subjects
Interval 30.0 to 48.0
|
79 percentage of Subjects
Interval 71.0 to 86.0
|
90 percentage of Subjects
Interval 84.0 to 95.0
|
54 percentage of Subjects
Interval 44.0 to 63.0
|
78 percentage of Subjects
Interval 69.0 to 85.0
|
92 percentage of Subjects
Interval 86.0 to 96.0
|
61 percentage of Subjects
Interval 52.0 to 70.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 29)_ baseline HI <1:10
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
75 percentage of Subjects
Interval 66.0 to 83.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
85 percentage of Subjects
Interval 77.0 to 91.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 43)_ baseline HI <1:10
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
75 percentage of Subjects
Interval 67.0 to 83.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 94.0 to 100.0
|
83 percentage of Subjects
Interval 75.0 to 90.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
91 percentage of Subjects
Interval 84.0 to 96.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 22)_ baseline HI ≥1:10
|
90 percentage of Subjects
Interval 77.0 to 97.0
|
80 percentage of Subjects
Interval 63.0 to 92.0
|
85 percentage of Subjects
Interval 71.0 to 94.0
|
93 percentage of Subjects
Interval 80.0 to 98.0
|
80 percentage of Subjects
Interval 65.0 to 91.0
|
97 percentage of Subjects
Interval 86.0 to 100.0
|
100 percentage of Subjects
Interval 88.0 to 100.0
|
76 percentage of Subjects
Interval 61.0 to 88.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 29)_ baseline HI ≥1:10
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
91 percentage of Subjects
Interval 76.0 to 98.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
97 percentage of Subjects
Interval 86.0 to 100.0
|
100 percentage of Subjects
Interval 90.0 to 100.0
|
100 percentage of Subjects
Interval 86.0 to 100.0
|
95 percentage of Subjects
Interval 83.0 to 99.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 22/Day 1)_baseline HI ≥ 1:10
|
83 percentage of Subjects
Interval 69.0 to 93.0
|
69 percentage of Subjects
Interval 51.0 to 83.0
|
73 percentage of Subjects
Interval 57.0 to 86.0
|
83 percentage of Subjects
Interval 68.0 to 93.0
|
71 percentage of Subjects
Interval 54.0 to 84.0
|
95 percentage of Subjects
Interval 82.0 to 99.0
|
89 percentage of Subjects
Interval 72.0 to 98.0
|
57 percentage of Subjects
Interval 41.0 to 72.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 29/Day 1)_baseline HI ≥ 1:10
|
97 percentage of Subjects
Interval 87.0 to 100.0
|
88 percentage of Subjects
Interval 72.0 to 97.0
|
95 percentage of Subjects
Interval 82.0 to 99.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
92 percentage of Subjects
Interval 79.0 to 98.0
|
100 percentage of Subjects
Interval 90.0 to 100.0
|
100 percentage of Subjects
Interval 86.0 to 100.0
|
85 percentage of Subjects
Interval 71.0 to 94.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 43/Day 1)_baseline HI ≥ 1:10
|
95 percentage of Subjects
Interval 84.0 to 99.0
|
86 percentage of Subjects
Interval 70.0 to 95.0
|
88 percentage of Subjects
Interval 74.0 to 96.0
|
95 percentage of Subjects
Interval 83.0 to 99.0
|
88 percentage of Subjects
Interval 74.0 to 96.0
|
97 percentage of Subjects
Interval 86.0 to 100.0
|
96 percentage of Subjects
Interval 82.0 to 100.0
|
81 percentage of Subjects
Interval 66.0 to 91.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 1)_ baseline HI ≥1:10
|
38 percentage of Subjects
Interval 24.0 to 54.0
|
40 percentage of Subjects
Interval 24.0 to 58.0
|
49 percentage of Subjects
Interval 33.0 to 65.0
|
41 percentage of Subjects
Interval 26.0 to 58.0
|
59 percentage of Subjects
Interval 42.0 to 74.0
|
38 percentage of Subjects
Interval 22.0 to 55.0
|
43 percentage of Subjects
Interval 24.0 to 63.0
|
45 percentage of Subjects
Interval 30.0 to 61.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 29/Day 1)_baseline HI < 1:10
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
75 percentage of Subjects
Interval 66.0 to 83.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 93.0 to 100.0
|
85 percentage of Subjects
Interval 77.0 to 91.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
97 percentage of Subjects
Interval 92.0 to 99.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 43/Day 1)_baseline HI < 1:10
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
75 percentage of Subjects
Interval 67.0 to 83.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
98 percentage of Subjects
Interval 94.0 to 100.0
|
83 percentage of Subjects
Interval 75.0 to 90.0
|
99 percentage of Subjects
Interval 95.0 to 100.0
|
100 percentage of Subjects
Interval 97.0 to 100.0
|
91 percentage of Subjects
Interval 84.0 to 96.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 1)_ baseline HI <1:10
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
0 percentage of Subjects
Interval 0.0 to 3.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 22)_ baseline HI <1:10
|
81 percentage of Subjects
Interval 72.0 to 88.0
|
39 percentage of Subjects
Interval 30.0 to 48.0
|
79 percentage of Subjects
Interval 71.0 to 86.0
|
90 percentage of Subjects
Interval 84.0 to 95.0
|
54 percentage of Subjects
Interval 44.0 to 63.0
|
78 percentage of Subjects
Interval 69.0 to 85.0
|
92 percentage of Subjects
Interval 86.0 to 96.0
|
61 percentage of Subjects
Interval 52.0 to 70.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 43)_ baseline HI ≥1:10
|
100 percentage of Subjects
Interval 92.0 to 100.0
|
91 percentage of Subjects
Interval 77.0 to 98.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
98 percentage of Subjects
Interval 87.0 to 100.0
|
100 percentage of Subjects
Interval 91.0 to 100.0
|
100 percentage of Subjects
Interval 88.0 to 100.0
|
93 percentage of Subjects
Interval 81.0 to 99.0
|
SECONDARY outcome
Timeframe: Day 1, Day 22, Day 29, Day 43Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline \[Day 1 (pre-vaccination)\] as compared to those who are seronegative (HI titer \< 1:10).
Outcome measures
| Measure |
3.75_(50)MF59
n=152 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=156 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=156 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=156 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=155 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=157 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=156 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=153 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMT Day 22_HI ≥1:10(42,35,41,41,41,37,28,42)
|
343 Titers
Interval 187.0 to 628.0
|
132 Titers
Interval 68.0 to 258.0
|
311 Titers
Interval 164.0 to 590.0
|
320 Titers
Interval 171.0 to 599.0
|
284 Titers
Interval 151.0 to 532.0
|
417 Titers
Interval 217.0 to 802.0
|
460 Titers
Interval 219.0 to 965.0
|
252 Titers
Interval 134.0 to 475.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMTDay 1 HI <1:10(110,121,115,115,114,120,128,11
|
5 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.1
|
5.1 Titers
Interval 5.0 to 5.1
|
5.1 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.07
|
5.1 Titers
Interval 5.0 to 5.2
|
5.1 Titers
Interval 5.0 to 5.2
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMTDay 22 HI<1:10(110,121,115,115,114,120,128,11
|
80 Titers
Interval 57.0 to 111.0
|
18 Titers
Interval 13.0 to 25.0
|
62 Titers
Interval 45.0 to 85.0
|
130 Titers
Interval 94.0 to 180.0
|
26 Titers
Interval 19.0 to 36.0
|
72 Titers
Interval 52.0 to 98.0
|
130 Titers
Interval 96.0 to 177.0
|
39 Titers
Interval 28.0 to 54.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMTDay 29HI <1:10(110,121,115,115,114,120,128,11
|
664 Titers
Interval 505.0 to 872.0
|
100 Titers
Interval 78.0 to 130.0
|
638 Titers
Interval 490.0 to 830.0
|
885 Titers
Interval 676.0 to 1157.0
|
149 Titers
Interval 114.0 to 194.0
|
685 Titers
Interval 527.0 to 890.0
|
950 Titers
Interval 736.0 to 1227.0
|
234 Titers
Interval 179.0 to 307.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMTDay 43HI <1:10(110,121,115,115,114,120,128,11
|
490 Titers
Interval 381.0 to 630.0
|
85 Titers
Interval 67.0 to 108.0
|
437 Titers
Interval 342.0 to 559.0
|
568 Titers
Interval 444.0 to 727.0
|
121 Titers
Interval 95.0 to 155.0
|
463 Titers
Interval 363.0 to 590.0
|
717 Titers
Interval 566.0 to 908.0
|
177 Titers
Interval 138.0 to 227.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMT Day 1 HI ≥ 1:10(42,35,41,41,41,37,28,42)
|
40 Titers
Interval 28.0 to 57.0
|
32 Titers
Interval 21.0 to 47.0
|
47 Titers
Interval 32.0 to 68.0
|
32 Titers
Interval 22.0 to 46.0
|
52 Titers
Interval 36.0 to 75.0
|
35 Titers
Interval 24.0 to 52.0
|
40 Titers
Interval 26.0 to 63.0
|
48 Titers
Interval 33.0 to 69.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMT Day 29_HI ≥1:10(42,35,41,41,41,37,28,42)
|
1178 Titers
Interval 782.0 to 1776.0
|
460 Titers
Interval 294.0 to 721.0
|
1063 Titers
Interval 689.0 to 1640.0
|
1281 Titers
Interval 843.0 to 1948.0
|
543 Titers
Interval 356.0 to 830.0
|
1197 Titers
Interval 771.0 to 1857.0
|
2088 Titers
Interval 1240.0 to 3516.0
|
641 Titers
Interval 422.0 to 973.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
GMT Day 43_HI ≥1:10(42,35,41,41,41,37,28,42)
|
876 Titers
Interval 604.0 to 1271.0
|
320 Titers
Interval 212.0 to 482.0
|
657 Titers
Interval 443.0 to 974.0
|
881 Titers
Interval 599.0 to 1295.0
|
464 Titers
Interval 316.0 to 684.0
|
838 Titers
Interval 561.0 to 1253.0
|
1184 Titers
Interval 751.0 to 1867.0
|
428 Titers
Interval 290.0 to 631.0
|
SECONDARY outcome
Timeframe: 7 days after first vaccinationPopulation: The analysis was performed on safety set population
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Outcome measures
| Measure |
3.75_(50)MF59
n=171 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=167 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=167 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=168 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=167 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=168 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=166 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=165 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Headache
|
24 Participants
|
15 Participants
|
30 Participants
|
37 Participants
|
16 Participants
|
25 Participants
|
27 Participants
|
17 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Pain
|
62 Participants
|
43 Participants
|
52 Participants
|
86 Participants
|
47 Participants
|
65 Participants
|
72 Participants
|
51 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Erythema
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Swelling
|
8 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
11 Participants
|
11 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Induration
|
14 Participants
|
5 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
15 Participants
|
12 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Tenderness
|
72 Participants
|
49 Participants
|
59 Participants
|
96 Participants
|
50 Participants
|
78 Participants
|
69 Participants
|
60 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Chills
|
8 Participants
|
3 Participants
|
9 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Myalgia
|
16 Participants
|
8 Participants
|
13 Participants
|
27 Participants
|
8 Participants
|
15 Participants
|
17 Participants
|
12 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Arthralgia
|
7 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Nausea
|
10 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
7 Participants
|
11 Participants
|
12 Participants
|
9 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Vomiting
|
4 Participants
|
5 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Diarrhoea
|
12 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
10 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Fatigue
|
27 Participants
|
17 Participants
|
23 Participants
|
29 Participants
|
17 Participants
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Fever
|
9 Participants
|
10 Participants
|
13 Participants
|
14 Participants
|
9 Participants
|
17 Participants
|
16 Participants
|
7 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Stayed home
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Analgesic./anti pyretic used
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days after second vaccinationPopulation: The analysis was performed on safety set population
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Outcome measures
| Measure |
3.75_(50)MF59
n=165 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=163 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=164 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=163 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=162 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=167 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=162 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=164 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Chills
|
7 Participant
|
5 Participant
|
5 Participant
|
4 Participant
|
7 Participant
|
4 Participant
|
3 Participant
|
3 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Myalgia
|
12 Participant
|
4 Participant
|
9 Participant
|
16 Participant
|
6 Participant
|
8 Participant
|
9 Participant
|
15 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Headache
|
12 Participant
|
12 Participant
|
12 Participant
|
19 Participant
|
14 Participant
|
11 Participant
|
13 Participant
|
9 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Diarrhoea
|
6 Participant
|
6 Participant
|
5 Participant
|
5 Participant
|
7 Participant
|
7 Participant
|
2 Participant
|
4 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Swelling
|
8 Participant
|
5 Participant
|
10 Participant
|
9 Participant
|
11 Participant
|
10 Participant
|
12 Participant
|
10 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Induration
|
10 Participant
|
2 Participant
|
9 Participant
|
6 Participant
|
9 Participant
|
15 Participant
|
13 Participant
|
10 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Tenderness
|
55 Participant
|
42 Participant
|
50 Participant
|
65 Participant
|
38 Participant
|
67 Participant
|
57 Participant
|
54 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Arthralgia
|
2 Participant
|
0 Participant
|
1 Participant
|
4 Participant
|
2 Participant
|
2 Participant
|
0 Participant
|
2 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Nausea
|
11 Participant
|
7 Participant
|
5 Participant
|
6 Participant
|
8 Participant
|
16 Participant
|
4 Participant
|
5 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Vomiting
|
6 Participant
|
3 Participant
|
4 Participant
|
7 Participant
|
3 Participant
|
3 Participant
|
3 Participant
|
3 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Pain
|
53 Participant
|
35 Participant
|
46 Participant
|
59 Participant
|
42 Participant
|
57 Participant
|
48 Participant
|
50 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Fatigue
|
16 Participant
|
11 Participant
|
15 Participant
|
14 Participant
|
17 Participant
|
10 Participant
|
13 Participant
|
6 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Fever
|
10 Participant
|
6 Participant
|
5 Participant
|
5 Participant
|
10 Participant
|
8 Participant
|
7 Participant
|
4 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Stayed home
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Analgesic/anti pyretic used
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
0 Participant
|
1 Participant
|
|
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Erythema
|
4 Participant
|
1 Participant
|
4 Participant
|
5 Participant
|
5 Participant
|
4 Participant
|
5 Participant
|
5 Participant
|
SECONDARY outcome
Timeframe: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccinationPopulation: The analysis was done on unsolicited safety set population.
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Outcome measures
| Measure |
3.75_(50)MF59
n=171 Participants
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=168 Participants
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=169 Participants
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=168 Participants
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=168 Participants
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=168 Participants
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=167 Participants
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=169 Participants
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
SAEs: all (Days 1-43)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AE leading to medically attended visits(Days 1-43)
|
31 Subjects
|
34 Subjects
|
25 Subjects
|
40 Subjects
|
34 Subjects
|
35 Subjects
|
28 Subjects
|
24 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs: all (Days 44-387)
|
95 Subjects
|
98 Subjects
|
102 Subjects
|
93 Subjects
|
90 Subjects
|
101 Subjects
|
90 Subjects
|
95 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs: all (Days 1-43)
|
98 Subjects
|
80 Subjects
|
80 Subjects
|
85 Subjects
|
86 Subjects
|
93 Subjects
|
79 Subjects
|
79 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs leading to premature withdrawal (Days 1-43)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs leading to new onset of chronic disorder
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
SAEs: all (Days 44-387)
|
0 Subjects
|
5 Subjects
|
6 Subjects
|
4 Subjects
|
3 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs leading to premature withdrawal (Days 44-387)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AEs leading to new onset of chronic dis.
|
2 Subjects
|
7 Subjects
|
4 Subjects
|
3 Subjects
|
4 Subjects
|
3 Subjects
|
6 Subjects
|
3 Subjects
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
AE leading to medically attended visit(Days44-387)
|
95 Subjects
|
97 Subjects
|
102 Subjects
|
93 Subjects
|
90 Subjects
|
100 Subjects
|
89 Subjects
|
95 Subjects
|
Adverse Events
3.75_(50)MF59
Serious events: 0 serious events
Other events: 171 other events
Deaths: 0 deaths
7.5 Without MF59
Serious events: 5 serious events
Other events: 168 other events
Deaths: 0 deaths
7.5_(50)MF59
Serious events: 7 serious events
Other events: 169 other events
Deaths: 0 deaths
7.5_(100)MF59
Serious events: 4 serious events
Other events: 168 other events
Deaths: 0 deaths
15 Without MF59
Serious events: 3 serious events
Other events: 168 other events
Deaths: 0 deaths
15_(50)MF59
Serious events: 4 serious events
Other events: 168 other events
Deaths: 0 deaths
15_(100)MF59
Serious events: 1 serious events
Other events: 167 other events
Deaths: 0 deaths
30 Without MF59
Serious events: 0 serious events
Other events: 169 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.75_(50)MF59
n=171 participants at risk
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=168 participants at risk
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=169 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=168 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=168 participants at risk
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=168 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=167 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=169 participants at risk
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • Number of events 1 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Otitis Media Chronic
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Staphylococcal Scalded Skin Syndrome
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Psychiatric disorders
Intermittent Explosive Disorder
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Psychiatric disorders
Oppositional Defiant Disorder
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.59%
1/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Reproductive system and breast disorders
Ovarian Mass
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Stenosis
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.60%
1/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
0.00%
0/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
Other adverse events
| Measure |
3.75_(50)MF59
n=171 participants at risk
50% of MF59 with 3.75 µg A/H1N1 antigen
|
7.5 Without MF59
n=168 participants at risk
1 dose of 7.5 µg A/H1N1
|
7.5_(50)MF59
n=169 participants at risk
50% of MF59 with 7.5 µg A/H1N1 antigen
|
7.5_(100)MF59
n=168 participants at risk
100% of MF59 with 7.5 µg A/H1N1 antigen
|
15 Without MF59
n=168 participants at risk
1 dose of 15 µg A/H1N1
|
15_(50)MF59
n=168 participants at risk
50% of MF59 with 15 µg A/H1N1 antigen
|
15_(100)MF59
n=167 participants at risk
100% of MF59 with 15 µg A/H1N1 antigen
|
30 Without MF59
n=169 participants at risk
1 dose of 30 µg A/H1N1
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
12.9%
22/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
16.0%
27/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.9%
20/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
12.0%
20/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
12.4%
21/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Injection site pain
|
57.3%
98/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
41.7%
70/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
50.3%
85/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
69.6%
117/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
50.6%
85/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
58.9%
99/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
59.9%
100/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
52.7%
89/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.9%
34/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
21.4%
36/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
17.8%
30/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
16.1%
27/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.2%
34/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.8%
35/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
24.0%
40/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
22.5%
38/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
14/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.9%
10/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.1%
7/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Pyrexia
|
24.0%
41/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.2%
34/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
22.5%
38/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.2%
34/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
26.2%
44/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.2%
34/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.4%
34/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
15.4%
26/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.8%
10/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.1%
7/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.0%
15/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Upper respiratory track infection
|
17.0%
29/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
21.4%
36/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.6%
23/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
15.5%
26/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
14.9%
25/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
12.5%
21/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
12.6%
21/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.0%
22/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Nervous system disorders
Headache
|
21.6%
37/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
18.5%
31/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
23.1%
39/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
26.2%
44/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
16.7%
28/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
22.0%
37/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
22.8%
38/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
16.6%
28/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Injection site erythema
|
17.0%
29/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.5%
16/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
15.4%
26/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
22.6%
38/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
14.9%
25/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
15.5%
26/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
21.6%
36/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
20.7%
35/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
24/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
21.4%
36/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.2%
22/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.0%
22/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Fatigue
|
19.3%
33/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.1%
22/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
18.3%
31/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
19.0%
32/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
17.9%
30/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
17.3%
29/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
21.6%
36/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.8%
20/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Injection site induration
|
13.5%
23/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.2%
19/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.7%
23/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
19.2%
32/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
14.2%
24/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Gastrointestinal disorders
Nausea
|
12.3%
21/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.9%
20/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.5%
16/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.7%
23/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.6%
16/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Gastrointestinal disorders
Diarrhea
|
12.9%
22/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.5%
16/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.1%
22/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.2%
12/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.5%
16/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Injection site swelling
|
9.9%
17/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.9%
20/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
14.4%
24/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
General disorders
Chills
|
9.9%
17/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.6%
11/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
9/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
1.2%
2/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Conjunctivitis
|
1.8%
3/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.9%
15/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Bronchitis
|
7.6%
13/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
1.8%
3/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Pharyngitis
|
7.6%
13/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.9%
15/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
9.9%
17/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.3%
19/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.9%
20/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.9%
15/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
11.9%
20/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.8%
13/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Sinusitis
|
5.3%
9/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.1%
7/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
1.8%
3/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.3%
9/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Viral Infection
|
7.6%
13/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.7%
13/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.8%
13/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
8.2%
14/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.9%
10/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.0%
10/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.6%
11/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.0%
12/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.6%
6/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.8%
8/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.7%
8/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.6%
13/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
7.1%
12/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.4%
14/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.8%
10/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.1%
7/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.4%
9/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.1%
17/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
9.0%
15/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
6.5%
11/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
Otitis Media
|
9.9%
17/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
8.3%
14/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
16.6%
28/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
12.5%
21/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
10.7%
18/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.8%
23/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
13.6%
23/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
5.3%
9/171 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
1.8%
3/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
2.4%
4/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
4.2%
7/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
1.8%
3/168 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
3.0%
5/167 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
5.3%
9/169 • All adverse events (AEs) and serious adverse events (SAEs) were collected for the whole study (study day 1 to day 387).
If the adverse event was solicited then the assessment was entered as systematic. However, if the adverse event was not solicited (unsolicited), then the assessment was entered as non-systematic.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place