Trial Outcomes & Findings for Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children (NCT NCT00317473)
NCT ID: NCT00317473
Last Updated: 2017-10-02
Results Overview
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
135 participants
Primary outcome timeframe
40 days
Results posted on
2017-10-02
Participant Flow
Subject were randomized in a 2:1 ratio between the FMP1/AS02A and Imovax vaccine groups.
Participant milestones
| Measure |
FMP1/AS02A Malaria Vaccine 10ug (Cohort A)
Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort A)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)
Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort B)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)
Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort C)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
15
|
30
|
15
|
30
|
15
|
|
Overall Study
COMPLETED
|
26
|
12
|
27
|
13
|
22
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
2
|
8
|
3
|
Reasons for withdrawal
| Measure |
FMP1/AS02A Malaria Vaccine 10ug (Cohort A)
Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort A)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)
Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort B)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)
Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort C)
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
1
|
3
|
1
|
|
Overall Study
Relocation
|
1
|
0
|
1
|
1
|
5
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
Baseline characteristics by cohort
| Measure |
FMP1/AS02A Malaria Vaccine 10ug (Cohort A)
n=29 Participants
Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort A)
n=15 Participants
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 25 ug (Cohort B)
n=30 Participants
Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort B)
n=15 Participants
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
FMP1/AS02A Malaria Vaccine 50 ug (Cohort C)
n=30 Participants
Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine
|
Imovax (Cohort C)
n=15 Participants
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.5 Months
STANDARD_DEVIATION 9.6 • n=5 Participants
|
28.8 Months
STANDARD_DEVIATION 9.7 • n=7 Participants
|
29.5 Months
STANDARD_DEVIATION 10.9 • n=5 Participants
|
29.9 Months
STANDARD_DEVIATION 11.2 • n=4 Participants
|
29.0 Months
STANDARD_DEVIATION 9.9 • n=21 Participants
|
29.2 Months
STANDARD_DEVIATION 10.9 • n=8 Participants
|
29.0 Months
STANDARD_DEVIATION 10.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
76 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Region of Enrollment
Kenya
|
29 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
15 participants
n=4 Participants
|
30 participants
n=21 Participants
|
15 participants
n=8 Participants
|
134 participants
n=8 Participants
|
|
Temperature (celcius)
|
36.36 Celcius
STANDARD_DEVIATION 0.42 • n=5 Participants
|
36.30 Celcius
STANDARD_DEVIATION 36.49 • n=7 Participants
|
36.49 Celcius
STANDARD_DEVIATION 0.57 • n=5 Participants
|
36.46 Celcius
STANDARD_DEVIATION 0.51 • n=4 Participants
|
36.50 Celcius
STANDARD_DEVIATION 0.62 • n=21 Participants
|
36.85 Celcius
STANDARD_DEVIATION 0.65 • n=8 Participants
|
36.45 Celcius
STANDARD_DEVIATION 0.54 • n=8 Participants
|
|
Pulse (bpm)
|
111.8 beats per minute (bpm)
STANDARD_DEVIATION 21.4 • n=5 Participants
|
102.7 beats per minute (bpm)
STANDARD_DEVIATION 24.4 • n=7 Participants
|
108.8 beats per minute (bpm)
STANDARD_DEVIATION 14.1 • n=5 Participants
|
116.5 beats per minute (bpm)
STANDARD_DEVIATION 18.0 • n=4 Participants
|
102.9 beats per minute (bpm)
STANDARD_DEVIATION 17.3 • n=21 Participants
|
119.7 beats per minute (bpm)
STANDARD_DEVIATION 19.0 • n=8 Participants
|
107.8 beats per minute (bpm)
STANDARD_DEVIATION 18.0 • n=8 Participants
|
|
Respiratory rate (bpm)
|
31.5 breaths per minute (bpm)
STANDARD_DEVIATION 5.3 • n=5 Participants
|
30.9 breaths per minute (bpm)
STANDARD_DEVIATION 5.5 • n=7 Participants
|
31.1 breaths per minute (bpm)
STANDARD_DEVIATION 5.3 • n=5 Participants
|
29.9 breaths per minute (bpm)
STANDARD_DEVIATION 2.8 • n=4 Participants
|
31.6 breaths per minute (bpm)
STANDARD_DEVIATION 5.2 • n=21 Participants
|
32.8 breaths per minute (bpm)
STANDARD_DEVIATION 5.4 • n=8 Participants
|
31.4 breaths per minute (bpm)
STANDARD_DEVIATION 5.2 • n=8 Participants
|
|
Systolic blood pressure (mmHg)
|
96.6 mmHg
STANDARD_DEVIATION 9.2 • n=5 Participants
|
96.4 mmHg
STANDARD_DEVIATION 14.5 • n=7 Participants
|
95.2 mmHg
STANDARD_DEVIATION 9.6 • n=5 Participants
|
96.1 mmHg
STANDARD_DEVIATION 11.8 • n=4 Participants
|
97.3 mmHg
STANDARD_DEVIATION 11.7 • n=21 Participants
|
94.4 mmHg
STANDARD_DEVIATION 14.1 • n=8 Participants
|
96.4 mmHg
STANDARD_DEVIATION 10.1 • n=8 Participants
|
|
Diastolic blood pressure (mmHg)
|
55.8 mmHg
STANDARD_DEVIATION 11.0 • n=5 Participants
|
54.5 mmHg
STANDARD_DEVIATION 11.5 • n=7 Participants
|
51.3 mmHg
STANDARD_DEVIATION 7.5 • n=5 Participants
|
53.3 mmHg
STANDARD_DEVIATION 10.1 • n=4 Participants
|
53.5 mmHg
STANDARD_DEVIATION 10.2 • n=21 Participants
|
52.0 mmHg
STANDARD_DEVIATION 8.0 • n=8 Participants
|
53.5 mmHg
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Height (cm)
|
84.7 cm
STANDARD_DEVIATION 7.0 • n=5 Participants
|
84.3 cm
STANDARD_DEVIATION 6.7 • n=7 Participants
|
84.8 cm
STANDARD_DEVIATION 9.0 • n=5 Participants
|
85.7 cm
STANDARD_DEVIATION 9.2 • n=4 Participants
|
83.1 cm
STANDARD_DEVIATION 6.9 • n=21 Participants
|
81.2 cm
STANDARD_DEVIATION 8.3 • n=8 Participants
|
84.2 cm
STANDARD_DEVIATION 7.6 • n=8 Participants
|
|
Weight (kg)
|
12.23 kg
STANDARD_DEVIATION 1.97 • n=5 Participants
|
11.97 kg
STANDARD_DEVIATION 2.10 • n=7 Participants
|
12.04 kg
STANDARD_DEVIATION 2.52 • n=5 Participants
|
12.51 kg
STANDARD_DEVIATION 3.11 • n=4 Participants
|
11.73 kg
STANDARD_DEVIATION 1.93 • n=21 Participants
|
11.04 kg
STANDARD_DEVIATION 2.17 • n=8 Participants
|
12.00 kg
STANDARD_DEVIATION 2.14 • n=8 Participants
|
PRIMARY outcome
Timeframe: 40 daysOccurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Outcome measures
| Measure |
FMP1/AS02A Malaria Vaccine
n=90 Participants
Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
|
Imovax Rabies Vaccine
n=45 Participants
Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
|
Overall
n=135 Participants
Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
|
FMP1/AS02A Any Imm
Subjects vaccinated within all immunization cycles
|
Imovax Imm 1
Subjects 1st vaccination with Imovax Rabies Vaccine
|
Imovax Imm 2
Subjects 2nd vaccination with Imovax Rabies Vaccine
|
Imovax Imm 3
Subjects 3rd vaccination with Imovax Rabies Vaccine
|
Imovax Any Imm
Subjects vaccinated within all immunization cycles
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 2 - Any Symptom
|
13 events
|
6 events
|
19 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 2 - Local
|
5 events
|
2 events
|
7 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 2 - General
|
10 events
|
4 events
|
14 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 3 - Any Symptom
|
4 events
|
2 events
|
6 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 3 - Local
|
1 events
|
0 events
|
1 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 3 - General
|
4 events
|
2 events
|
6 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Any Imm - Any Symptom
|
28 events
|
10 events
|
38 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Any Imm - Local
|
24 events
|
1 events
|
25 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Any Imm - General
|
18 events
|
10 events
|
28 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 1 - Any Symptom
|
21 events
|
6 events
|
27 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 1 - Local
|
14 events
|
0 events
|
14 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 1 - General
|
12 events
|
6 events
|
18 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 2 - Any Symptom
|
15 events
|
5 events
|
20 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 2 - Local
|
12 events
|
1 events
|
13 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 2 - General
|
8 events
|
5 events
|
13 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 3 - Any Symptom
|
15 events
|
4 events
|
19 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 3 - Local
|
11 events
|
0 events
|
11 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort B: Imm 3 - General
|
7 events
|
4 events
|
11 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Any Imm - Any Symptom
|
28 events
|
8 events
|
36 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Any Imm - Local
|
26 events
|
2 events
|
28 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Any Imm - General
|
20 events
|
6 events
|
26 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 1 - Any Symptom
|
24 events
|
4 events
|
28 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 1 - Local
|
18 events
|
1 events
|
19 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 1 - General
|
15 events
|
3 events
|
18 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 2 - Any Symptom
|
19 events
|
4 events
|
23 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 2 - Local
|
17 events
|
1 events
|
18 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 2 - General
|
10 events
|
3 events
|
13 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 3 - Any Symptom
|
22 events
|
2 events
|
24 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 3 - Local
|
19 events
|
0 events
|
19 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort C: Imm 3 - General
|
10 events
|
2 events
|
12 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Any Imm - Any Symptom
|
24 events
|
11 events
|
35 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Any Imm - Local
|
15 events
|
2 events
|
17 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Any Imm - General
|
18 events
|
10 events
|
29 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 1 - Any Symptom
|
16 events
|
7 events
|
23 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 1 - Local
|
9 events
|
0 events
|
9 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Cohort A: Imm 1 - General
|
11 events
|
7 events
|
18 events
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 90 daysOccurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
Outcome measures
| Measure |
FMP1/AS02A Malaria Vaccine
n=30 Participants
Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
|
Imovax Rabies Vaccine
n=30 Participants
Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
|
Overall
n=28 Participants
Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
|
FMP1/AS02A Any Imm
n=88 Participants
Subjects vaccinated within all immunization cycles
|
Imovax Imm 1
n=15 Participants
Subjects 1st vaccination with Imovax Rabies Vaccine
|
Imovax Imm 2
n=14 Participants
Subjects 2nd vaccination with Imovax Rabies Vaccine
|
Imovax Imm 3
n=13 Participants
Subjects 3rd vaccination with Imovax Rabies Vaccine
|
Imovax Any Imm
n=42 Participants
Subjects vaccinated within all immunization cycles
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Parasitic Infection
|
19 events
|
15 events
|
13 events
|
27 events
|
9 events
|
5 events
|
8 events
|
13 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Resistance Mechanism
|
13 events
|
18 events
|
14 events
|
28 events
|
5 events
|
7 events
|
4 events
|
10 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Skin and appendages
|
7 events
|
14 events
|
11 events
|
20 events
|
8 events
|
5 events
|
4 events
|
11 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Respiratory System
|
10 events
|
8 events
|
4 events
|
18 events
|
5 events
|
7 events
|
2 events
|
11 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Gastrointestinal System
|
7 events
|
9 events
|
4 events
|
17 events
|
0 events
|
3 events
|
6 events
|
7 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Body as a Whole: General
|
5 events
|
6 events
|
2 events
|
10 events
|
2 events
|
2 events
|
1 events
|
4 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Vision
|
0 events
|
4 events
|
2 events
|
6 events
|
2 events
|
1 events
|
1 events
|
4 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Red Blood Cells
|
1 events
|
1 events
|
2 events
|
4 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Unclassified
|
0 events
|
1 events
|
1 events
|
2 events
|
1 events
|
0 events
|
0 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Application Site
|
0 events
|
1 events
|
0 events
|
1 events
|
1 events
|
0 events
|
0 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort A: Urinary System
|
1 events
|
0 events
|
1 events
|
2 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Resistance Mechnism
|
14 events
|
15 events
|
13 events
|
24 events
|
7 events
|
11 events
|
7 events
|
15 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Parasitic Infection
|
14 events
|
14 events
|
12 events
|
25 events
|
9 events
|
7 events
|
6 events
|
13 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Skin and Appedages
|
11 events
|
13 events
|
5 events
|
20 events
|
5 events
|
5 events
|
4 events
|
8 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Respiratory System
|
11 events
|
13 events
|
5 events
|
20 events
|
5 events
|
5 events
|
4 events
|
8 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Gastrointestinal System
|
6 events
|
6 events
|
5 events
|
13 events
|
2 events
|
1 events
|
3 events
|
6 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Body as a Whole: General
|
8 events
|
4 events
|
3 events
|
12 events
|
1 events
|
1 events
|
3 events
|
4 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Vision
|
1 events
|
7 events
|
4 events
|
11 events
|
2 events
|
2 events
|
1 events
|
5 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Liver and Biliary System
|
1 events
|
0 events
|
3 events
|
4 events
|
1 events
|
1 events
|
0 events
|
2 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Unclassified
|
1 events
|
0 events
|
2 events
|
3 events
|
2 events
|
0 events
|
1 events
|
3 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Musculoskeletal System
|
1 events
|
1 events
|
1 events
|
3 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Red Blood Cells
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
2 events
|
0 events
|
2 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Central and Peripheral Nervous
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
0 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Hearing and Vestibular
|
1 events
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort B: Urinary System
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Resistance Mechanism
|
18 events
|
18 events
|
10 events
|
25 events
|
8 events
|
7 events
|
8 events
|
13 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Parasitic Infection
|
14 events
|
11 events
|
8 events
|
17 events
|
10 events
|
10 events
|
7 events
|
13 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Skin and Appendages
|
9 events
|
12 events
|
2 events
|
17 events
|
5 events
|
4 events
|
4 events
|
10 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Respiratory System
|
10 events
|
1 events
|
4 events
|
12 events
|
7 events
|
3 events
|
3 events
|
10 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Gastrointestinal System
|
2 events
|
8 events
|
5 events
|
12 events
|
3 events
|
2 events
|
5 events
|
8 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Body as a Whole: General
|
4 events
|
4 events
|
3 events
|
10 events
|
1 events
|
1 events
|
2 events
|
3 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Vision
|
7 events
|
1 events
|
1 events
|
8 events
|
2 events
|
2 events
|
0 events
|
4 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Unclassified
|
1 events
|
2 events
|
3 events
|
6 events
|
1 events
|
0 events
|
1 events
|
2 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Hearing and Vestibular
|
0 events
|
1 events
|
0 events
|
1 events
|
0 events
|
0 events
|
1 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Red Blood Cells
|
0 events
|
1 events
|
0 events
|
1 events
|
1 events
|
0 events
|
0 events
|
1 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Central and Peripheral Nervous
|
0 events
|
1 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Liver and Biliary System
|
0 events
|
1 events
|
0 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Cohort C: Urinary System
|
0 events
|
0 events
|
1 events
|
1 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: 8 monthsOccurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
Outcome measures
| Measure |
FMP1/AS02A Malaria Vaccine
n=89 Participants
Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
|
Imovax Rabies Vaccine
n=45 Participants
Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
|
Overall
n=134 Participants
Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
|
FMP1/AS02A Any Imm
Subjects vaccinated within all immunization cycles
|
Imovax Imm 1
Subjects 1st vaccination with Imovax Rabies Vaccine
|
Imovax Imm 2
Subjects 2nd vaccination with Imovax Rabies Vaccine
|
Imovax Imm 3
Subjects 3rd vaccination with Imovax Rabies Vaccine
|
Imovax Any Imm
Subjects vaccinated within all immunization cycles
|
|---|---|---|---|---|---|---|---|---|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort B: Any SAE
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort B: Imm 1
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort A: Any SAE
|
2 events
|
1 events
|
3 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort A: Imm 1
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort A: Imm 2
|
1 events
|
0 events
|
1 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort A: Imm 3
|
1 events
|
1 events
|
2 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort B: Imm 2
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort B: Imm 3
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort C: Any SAE
|
1 events
|
0 events
|
1 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort C: Imm 1
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort C: Imm 2
|
1 events
|
0 events
|
1 events
|
—
|
—
|
—
|
—
|
—
|
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Cohort C: Imm 3
|
0 events
|
0 events
|
0 events
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 364 daysAntibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine
Outcome measures
| Measure |
FMP1/AS02A Malaria Vaccine
n=29 Participants
Subject vaccinated with FMP1/AS02A (cohorts A, B, and C)
|
Imovax Rabies Vaccine
n=15 Participants
Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C)
|
Overall
n=30 Participants
Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C)
|
FMP1/AS02A Any Imm
n=15 Participants
Subjects vaccinated within all immunization cycles
|
Imovax Imm 1
n=30 Participants
Subjects 1st vaccination with Imovax Rabies Vaccine
|
Imovax Imm 2
n=15 Participants
Subjects 2nd vaccination with Imovax Rabies Vaccine
|
Imovax Imm 3
Subjects 3rd vaccination with Imovax Rabies Vaccine
|
Imovax Any Imm
Subjects vaccinated within all immunization cycles
|
|---|---|---|---|---|---|---|---|---|
|
Anti-FMP1 Antibody Titer Responses
Pre-Imm 1
|
2141 titers
Interval 1090.0 to 4205.0
|
2814 titers
Interval 827.0 to 9757.0
|
2737 titers
Interval 1492.0 to 5023.0
|
3226 titers
Interval 1250.0 to 8328.0
|
2301 titers
Interval 1074.0 to 4930.0
|
1041 titers
Interval 319.0 to 3401.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 14
|
2711 titers
Interval 1524.0 to 4824.0
|
2857 titers
Interval 827.0 to 9757.0
|
4784 titers
Interval 2702.0 to 8469.0
|
2520 titers
Interval 835.0 to 7604.0
|
5729 titers
Interval 3320.0 to 9887.0
|
944 titers
Interval 361.0 to 2470.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Pre-Imm 2
|
2440 titers
Interval 1449.0 to 41088.0
|
2829 titers
Interval 832.0 to 9611.0
|
2777 titers
Interval 1522.0 to 5065.0
|
4282 titers
Interval 1465.0 to 12516.0
|
4705 titers
Interval 2870.0 to 7714.0
|
1041 titers
Interval 396.0 to 2731.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 44
|
4438 titers
Interval 2579.0 to 7637.0
|
2562 titers
Interval 724.0 to 9067.0
|
8390 titers
Interval 4733.0 to 14874.0
|
3593 titers
Interval 1185.0 to 10894.0
|
10791 titers
Interval 5421.0 to 21479.0
|
1105 titers
Interval 384.0 to 3178.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Pre-Imm 3
|
4534 titers
Interval 2854.0 to 7202.0
|
2013 titers
Interval 412.0 to 9832.0
|
10240 titers
Interval 6409.0 to 16360.0
|
2258 titers
Interval 780.0 to 6537.0
|
10631 titers
Interval 5599.0 to 20184.0
|
1034 titers
Interval 388.0 to 2751.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 74
|
10151 titers
Interval 6328.0 to 16285.0
|
1529 titers
Interval 421.0 to 5546.0
|
43399 titers
Interval 29132.0 to 64653.0
|
3368 titers
Interval 1295.0 to 8758.0
|
50166 titers
Interval 28307.0 to 88906.0
|
790 titers
Interval 306.0 to 2039.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 90
|
10332 titers
Interval 5944.0 to 17960.0
|
1768 titers
Interval 431.0 to 7246.0
|
27189 titers
Interval 17827.0 to 41468.0
|
2909 titers
Interval 1251.0 to 8765.0
|
34657 titers
Interval 18914.0 to 63305.0
|
1039 titers
Interval 371.0 to 2910.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 180
|
5354 titers
Interval 2954.0 to 9702.0
|
1788 titers
Interval 514.0 to 6213.0
|
13496 titers
Interval 8514.0 to 21392.0
|
4318 titers
Interval 1532.0 to 12170.0
|
14840 titers
Interval 7481.0 to 29434.0
|
999 titers
Interval 443.0 to 2257.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 270
|
6190 titers
Interval 3520.0 to 10886.0
|
1877 titers
Interval 484.0 to 7278.0
|
14839 titers
Interval 8301.0 to 26527.0
|
6020 titers
Interval 2142.0 to 16921.0
|
15380 titers
Interval 8127.0 to 29108.0
|
1970 titers
Interval 659.0 to 5891.0
|
—
|
—
|
|
Anti-FMP1 Antibody Titer Responses
Day 364
|
4115 titers
Interval 2235.0 to 7574.0
|
2238 titers
Interval 641.0 to 7812.0
|
12043 titers
Interval 6585.0 to 22027.0
|
4005 titers
Interval 1351.0 to 11872.0
|
8807 titers
Interval 4083.0 to 18996.0
|
1295 titers
Interval 399.0 to 4204.0
|
—
|
—
|
Adverse Events
FMP1/AS02A Malaria Vaccine
Serious events: 3 serious events
Other events: 87 other events
Deaths: 1 deaths
Imovax
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FMP1/AS02A Malaria Vaccine
n=90 participants at risk
Subject vaccinated with FMP1/AS02A
|
Imovax
n=45 participants at risk
Subject vaccinated with Imovax Rabies Vaccine
|
|---|---|---|
|
Nervous system disorders
Convulsions
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Anemia
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Nervous system disorders
Convulstions
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
Other adverse events
| Measure |
FMP1/AS02A Malaria Vaccine
n=90 participants at risk
Subject vaccinated with FMP1/AS02A
|
Imovax
n=45 participants at risk
Subject vaccinated with Imovax Rabies Vaccine
|
|---|---|---|
|
General disorders
Fever
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Metabolism and nutrition disorders
Loss of appetite
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Pain at injection site
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Swelling at injection site
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Pain at the injection site
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Irritability
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Metabolism and nutrition disorders
Loss of appetate
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Pain at injections site
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Pain at injection site
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Swelling at injection site
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Blood and lymphatic system disorders
Malaria
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Gingivitis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Oral candidiasis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Upper respiratory tract infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Superficial burn
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Folliculitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Poor feeding
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Small plaques
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Furunculosis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Cellulitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Injection site induration
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Renal and urinary disorders
Micturition disorder
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Otitis media
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Foriegn body in throat
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Enterobiasis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Tinea corporis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Stomatitis ulcerative
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Moniliasis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Blood and lymphatic system disorders
Marlaria
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Eye disorders
Eye pain
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Foriegn body in nostril
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Tinea corporis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Pain
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Herpes simplex
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Conjunctivtis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
History of fever
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Loose stool
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Reproductive system and breast disorders
Coughing
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Investigations
SBPT increased
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Septic lesion left pinna
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Helminthiasis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Stomatitis ulceratived
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Rectal disorder
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Investigations
SGPT increased
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Conjuctivitis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Abscess
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
General disorders
Gluteal ulcer
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Upper resporatory tract infection
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
History of fever
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Upper respriatory tract infection
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Nervous system disorders
Headache
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Conjunctivitis
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Septic wound secondary to trauma
|
1.1%
1/90 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
0.00%
0/45 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Upper respitratory tract infection
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Pruritus
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Injury, poisoning and procedural complications
Injection site hyperpigmentation
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Conjuntivitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Pruritis ani
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Gingivitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Rhinitis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Coryza
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Ear and labyrinth disorders
Otitis exrterna
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
tinea corporis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Monilliasis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Infections and infestations
Septic wound
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/90 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
2.2%
1/45 • Number of events 1 • 240 days
The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place