Trial Outcomes & Findings for FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali (NCT NCT00349713)
NCT ID: NCT00349713
Last Updated: 2017-07-24
Results Overview
The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
12 months
Results posted on
2017-07-24
Participant Flow
175 participants were screened; 115 were excluded; 60 subjects were randomized in a 2:1 ratio into 2 cohorts
Participant milestones
| Measure |
Cohort 1: FMP2.1 / AS02A
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: FMP2.1 / AS02A
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Baseline characteristics by cohort
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Region of Enrollment
Mali
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Summary of Adverse Events by Group and Immunization Group
The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.
Outcome measures
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Injection Site Pain
|
45 Number of events
|
53 Number of events
|
22 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Injection Site Swelling
|
37 Number of events
|
35 Number of events
|
11 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Arm Motion Limitation
|
5 Number of events
|
3 Number of events
|
0 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Elevated Temperature
|
6 Number of events
|
6 Number of events
|
1 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Headache
|
7 Number of events
|
17 Number of events
|
9 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Chills
|
4 Number of events
|
2 Number of events
|
4 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Malaise
|
4 Number of events
|
5 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Nausea
|
4 Number of events
|
1 Number of events
|
1 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Arthralgia
|
0 Number of events
|
2 Number of events
|
1 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Myalgia
|
3 Number of events
|
6 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Solicited: Erythema
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Cold
|
21 Number of events
|
10 Number of events
|
7 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Headaches
|
11 Number of events
|
11 Number of events
|
5 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Coughing
|
8 Number of events
|
3 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Flu
|
6 Number of events
|
3 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Wound
|
3 Number of events
|
2 Number of events
|
4 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Myalgia
|
2 Number of events
|
2 Number of events
|
4 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Scratch
|
1 Number of events
|
2 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Diarrhea
|
1 Number of events
|
2 Number of events
|
3 Number of events
|
|
Safety and Reactogenicity (SAEs and AEs)
Unsolicited: Pruritus
|
1 Number of events
|
4 Number of events
|
1 Number of events
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90
Measurement of anti-AMA1 antibody titers over time
Outcome measures
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Antibody Response to FMP2.1 Over Time
Day 0
|
53295.3 Antibody Titers
Standard Deviation 76881
|
56779.4 Antibody Titers
Standard Deviation 53811.2
|
59852 Antibody Titers
Standard Deviation 101952.4
|
|
Antibody Response to FMP2.1 Over Time
Day 14
|
62963.8 Antibody Titers
Standard Deviation 77633.3
|
120677.4 Antibody Titers
Standard Deviation 104675.9
|
63697.6 Antibody Titers
Standard Deviation 119009.9
|
|
Antibody Response to FMP2.1 Over Time
Day 30
|
68251.2 Antibody Titers
Standard Deviation 87406.5
|
101464.5 Antibody Titers
Standard Deviation 99045.2
|
51436.1 Antibody Titers
Standard Deviation 95888.9
|
|
Antibody Response to FMP2.1 Over Time
Day 44
|
101478.2 Antibody Titers
Standard Deviation 139781.1
|
159449.2 Antibody Titers
Standard Deviation 152111.2
|
62498.3 Antibody Titers
Standard Deviation 115667.3
|
|
Antibody Response to FMP2.1 Over Time
Day 60
|
103966.8 Antibody Titers
Standard Deviation 117998.7
|
187453.9 Antibody Titers
Standard Deviation 162090.9
|
77418.1 Antibody Titers
Standard Deviation 147844.9
|
|
Antibody Response to FMP2.1 Over Time
Day 74
|
128323.7 Antibody Titers
Standard Deviation 109759
|
227692.0 Antibody Titers
Standard Deviation 236420.5
|
82794.3 Antibody Titers
Standard Deviation 173534.6
|
|
Antibody Response to FMP2.1 Over Time
Day 90
|
87684.2 Antibody Titers
Standard Deviation 99596.7
|
162739.7 Antibody Titers
Standard Deviation 182897.2
|
52575.5 Antibody Titers
Standard Deviation 99568.0
|
SECONDARY outcome
Timeframe: 90 DaysSummary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Outcome measures
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 0
|
4.3 log antibody titers
Standard Deviation 0.7
|
44.4 log antibody titers
Standard Deviation 0.9
|
4.2 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 14
|
4.5 log antibody titers
Standard Deviation 0.6
|
4.8 log antibody titers
Standard Deviation 0.6
|
4.1 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 30
|
4.5 log antibody titers
Standard Deviation 0.6
|
4.7 log antibody titers
Standard Deviation 0.6
|
4.1 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 44
|
4.7 log antibody titers
Standard Deviation 0.5
|
5.0 log antibody titers
Standard Deviation 0.5
|
4.1 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 60
|
4.8 log antibody titers
Standard Deviation 0.5
|
5.1 log antibody titers
Standard Deviation 0.5
|
4.2 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 74
|
4.9 log antibody titers
Standard Deviation 0.4
|
5.2 log antibody titers
Standard Deviation 0.4
|
4.1 log antibody titers
Standard Deviation 0.8
|
|
Anti-AMA1 Log Antibody Titers Over Time
Day 90
|
4.8 log antibody titers
Standard Deviation 0.4
|
5.0 log antibody titers
Standard Deviation 0.4
|
4.0 log antibody titers
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 90 DaysMeasurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Outcome measures
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Geometric Mean Antibody Titers Over Time
Day 0
|
19161.2 Geometric Mean of Antibody Titers
Interval 8569.5 to 42843.9
|
23499.7 Geometric Mean of Antibody Titers
Interval 9078.9 to 60825.6
|
14354.8 Geometric Mean of Antibody Titers
Interval 5859.8 to 35164.9
|
|
Geometric Mean Antibody Titers Over Time
Day 14
|
30795.3 Geometric Mean of Antibody Titers
Interval 16398.1 to 57829.4
|
69751.6 Geometric Mean of Antibody Titers
Interval 37929.2 to 128272.7
|
13856.7 Geometric Mean of Antibody Titers
Interval 5568.2 to 34483.1
|
|
Geometric Mean Antibody Titers Over Time
Day 30
|
31804.9 Geometric Mean of Antibody Titers
Interval 16571.8 to 61040.8
|
55085.8 Geometric Mean of Antibody Titers
Interval 29386.5 to 103260.1
|
12690.7 Geometric Mean of Antibody Titers
Interval 5296.6 to 30407.1
|
|
Geometric Mean Antibody Titers Over Time
Day 44
|
55246.5 Geometric Mean of Antibody Titers
Interval 33102.4 to 92204.0
|
100589.6 Geometric Mean of Antibody Titers
Interval 61275.4 to 165127.7
|
13941.2 Geometric Mean of Antibody Titers
Interval 5719.8 to 33979.9
|
|
Geometric Mean Antibody Titers Over Time
Day 60
|
61438.6 Geometric Mean of Antibody Titers
Interval 36763.7 to 102674.5
|
119191.3 Geometric Mean of Antibody Titers
Interval 71967.1 to 197403.6
|
16030.5 Geometric Mean of Antibody Titers
Interval 6502.6 to 39518.8
|
|
Geometric Mean Antibody Titers Over Time
Day 74
|
89856.7 Geometric Mean of Antibody Titers
Interval 57817.9 to 139649.3
|
150738.4 Geometric Mean of Antibody Titers
Interval 97729.2 to 232500.5
|
14064.5 Geometric Mean of Antibody Titers
Interval 5534.1 to 35743.6
|
|
Geometric Mean Antibody Titers Over Time
Day 90
|
60967.1 Geometric Mean of Antibody Titers
Interval 41140.3 to 90348.9
|
102813.0 Geometric Mean of Antibody Titers
Interval 65715.6 to 160852.4
|
10425.1 Geometric Mean of Antibody Titers
Interval 4079.6 to 26640.2
|
SECONDARY outcome
Timeframe: 90 DaysProportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90
Outcome measures
| Measure |
Cohort 1: 25ug FMP2.1 / AS02A
n=20 Participants
20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohort 2: 50ug FMP2.1 / AS02A
n=20 Participants
20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A
|
Cohorts 1 and 2: Rabies Vaccine (RabAvert)
n=20 Participants
20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine
|
|---|---|---|---|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 14 2-fold increase
|
5 number of participants with increase
|
9 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 14 4-fold increase
|
1 number of participants with increase
|
5 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 30 2-fold increase
|
2 number of participants with increase
|
4 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 30 4-fold increase
|
2 number of participants with increase
|
4 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 44 2-fold increase
|
3 number of participants with increase
|
6 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 44 4-fold increase
|
3 number of participants with increase
|
6 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 60 2-fold increase
|
6 number of participants with increase
|
7 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 60 4-fold increase
|
6 number of participants with increase
|
7 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 74 2-fold increase
|
9 number of participants with increase
|
11 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 74 4-fold increase
|
9 number of participants with increase
|
11 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 90 2-fold increase
|
6 number of participants with increase
|
7 number of participants with increase
|
0 number of participants with increase
|
|
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Day 90 4-fold increase
|
6 number of participants with increase
|
7 number of participants with increase
|
0 number of participants with increase
|
Adverse Events
Cohort 1: 25 ug FMP2.1 / AS02
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 2: 50 ug FMP2.1 / AS02A
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 3: Rabies Vaccine (RabAvert)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: 25 ug FMP2.1 / AS02
n=20 participants at risk
25 ug FMPs.1 / AS02
|
Cohort 2: 50 ug FMP2.1 / AS02A
n=20 participants at risk
50 ug FMP2.1 / AS02A
|
Cohort 3: Rabies Vaccine (RabAvert)
n=20 participants at risk
Rabies vaccine, All events reports instead of AE's per vaccination group 20 subjects (10 from Cohort 1 and 10 from Cohort 2)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
20.0%
4/20 • Number of events 4 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Abrasion from scratching
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Acute injection site pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Acute lower back pain
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Acute left inferior deltoid pain
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pharyngitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute rhinitis
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute viral rhinitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Immune system disorders
Allergic cold symptoms
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Immune system disorders
Allergic conjunctivitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Metabolism and nutrition disorders
Anorxia
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Infections and infestations
Bacterial conjunctivitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Bilateral ocular pruritus
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Bilateral pruritus of forearms
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Bilious vomiting
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Blood streak in stool
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Boil
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Bullous pruritic lesions of upper extremities
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Burning muscular pain
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Renal and urinary disorders
Burning with urination
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Chalazion
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Chills
|
30.0%
6/20 • Number of events 6 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
35.0%
7/20 • Number of events 7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
65.0%
13/20 • Number of events 13 • 12 months
|
25.0%
5/20 • Number of events 5 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms with productive cough
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Coxalgy
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Infections and infestations
Dental abscess tooth #21
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Dental cavity tooth #18
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Surgical and medical procedures
Dental extraction
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Dermatomycosis of inguinal folds
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
|
Nervous system disorders
Diffuse headache
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
40.0%
8/20 • Number of events 8 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Dysentery
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Metabolism and nutrition disorders
Edema of left anterior forearm
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Vascular disorders
Elevated blood pressure = 150/90 mmHg
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Investigations
Elevated temperature
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Infections and infestations
Epididymitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Epigastric pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Vascular disorders
Epistaxis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema extending from injection site
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Evening headache
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Excessive sweating
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Cardiac disorders
Extrasystol
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Eye disorders
Eye pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Eye tearing and itching
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Facial sweating
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Fatigue
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Febrile at 37.5 C
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Febrile to 37.8 C
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Cardiac disorders
Heart racing
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Fever
|
30.0%
6/20 • Number of events 6 • 12 months
|
20.0%
4/20 • Number of events 4 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
|
General disorders
Flu like symptoms
|
55.0%
11/20 • Number of events 11 • 12 months
|
40.0%
8/20 • Number of events 8 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Foreign body in eye causing tearing
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Frontal headache
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Frontal sinusitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Generalized pruritus and skin papules
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Gingivitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Surgical and medical procedures
Groin elongation
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Gum pain following tooth extraction
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Headache
|
100.0%
20/20 • Number of events 20 • 12 months
|
85.0%
17/20 • Number of events 17 • 12 months
|
25.0%
5/20 • Number of events 5 • 12 months
|
|
Nervous system disorders
Headache in frontal region
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Headache in temporal region
|
5.0%
1/20 • Number of events 1 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Headaches
|
15.0%
3/20 • Number of events 3 • 12 months
|
35.0%
7/20 • Number of events 7 • 12 months
|
25.0%
5/20 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Heartburn
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Vascular disorders
Hemorrhoids
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Immune system disorders
Hives
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Hypochondrium pain
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Induced injection site pain
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site edema (grade 1)
|
20.0%
4/20 • Number of events 4 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site edema (grade 2
|
100.0%
20/20 • Number of events 20 • 12 months
|
45.0%
9/20 • Number of events 9 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site edema (grade 3)
|
45.0%
9/20 • Number of events 9 • 12 months
|
100.0%
20/20 • Number of events 20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain (grade 1)
|
100.0%
20/20 • Number of events 20 • 12 months
|
100.0%
20/20 • Number of events 20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain (grade 2)
|
5.0%
1/20 • Number of events 1 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain with pulsatile sensation (grade 1)
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain extending to left elbow (grade 1)
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain extending to left shoulder (grade 1)
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pain with movement (grade 1)
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pruritus
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injection site pulsation (grade 1)
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
40.0%
8/20 • Number of events 8 • 12 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Isolated pruritus of the umbilical region
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Keratitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Conjunctivitis left eye
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Left food punture wound
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Left foot scratch
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Left foot wound on lateral, external aspect
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Ear and labyrinth disorders
Left otalgia
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Reproductive system and breast disorders
Left pelvic pain
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Left rhinitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Left upper premolar tooth pain
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Limitation of arm movement
|
25.0%
5/20 • Number of events 5 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Liquid diarrhea
|
5.0%
1/20 • Number of events 1 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lombalgia
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
20.0%
4/20 • Number of events 4 • 12 months
|
|
Nervous system disorders
Loss of balance with movement
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
10.0%
2/20 • Number of events 2 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Malaise
|
30.0%
6/20 • Number of events 6 • 12 months
|
35.0%
7/20 • Number of events 7 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Mucsle aches
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain of abdominal muscles and at venipuncture site
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscular pain of right lower extremity following trauma
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Number of events 5 • 12 months
|
55.0%
11/20 • Number of events 11 • 12 months
|
20.0%
4/20 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 5 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Needle stick injury
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nighttime cough
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nighttime wet cough triggered by cigarette smoke
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Non-pruritic papule
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Ocular affection
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Vascular disorders
Orthostatic hypotension
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Pain at venipuncture site
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Pain in right hypochondium
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in anterior left forearm
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain of right knee
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Pain of right hypochondrium
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Pain with shaking of the right hypochondrium
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Renal and urinary disorders
Pain with urination
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Surgical and medical procedures
Painful dental cavity (tooth extraction)
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Cardiac disorders
Palpitation
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Papule of the posterior ankle and inferior left abdominal flank
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Papule on mid-flank of right abdomen
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Papule pruritus
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
|
Skin and subcutaneous tissue disorders
Papule unpruritus
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Papules + pruritus following an insect bite
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Nervous system disorders
Paroxysmal vertigo
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Periodontitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Physical weakness
|
10.0%
2/20 • Number of events 2 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Pityriasis versicolor
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Reproductive system and breast disorders
Positive urine pregnancy test
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Surgical and medical procedures
post-operative pain at wound site
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Metabolism and nutrition disorders
Post-traumatic edema of forehead
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Post-traumatic pain of the right elbow and wrist
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Post-traumatic right foot pain
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Cardiac disorders
Premature/ectopic heart beat
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Presence of blood in stools
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritic papules
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritis of internal face of thighs
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritis papule
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritis with papules and excoriation
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritis with skin abrasions from scratching
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pulled groin muscle
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Purulent conjunctivitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
40.0%
8/20 • Number of events 8 • 12 months
|
45.0%
9/20 • Number of events 9 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis of mucous membranes
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinobronchitis
|
10.0%
2/20 • Number of events 2 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinopharyngitis
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinosinusitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Right ankle pain after dislocation since 2002
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Right ankle traumatic wound
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Right eye conjunctivitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Right eye pain
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Right eye pterygium
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Right index finger traumatic wound
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Right leg traumatic wound
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Right lumbar pain
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Ear and labyrinth disorders
Right otitis
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Right tonsillitis
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Right wrist scratch on posterior aspect
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Ear and labyrinth disorders
Ringing in the ears
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Scratch
|
5.0%
1/20 • Number of events 1 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Scratch of anterior/external aspect of the thigh
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Sensation of arm heaviness
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Sensation of head heaviness
|
0.00%
0/20 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Sense of pulsation at injection site
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinisitis + Rhinitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Subjective evening fever
|
10.0%
2/20 • Number of events 2 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Super infected wounds on left leg
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Surgical and medical procedures
Surgical hernia repair
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Sweats
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Swelling of right thumb
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Syndrome of tissue hyperfusion
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Syndrome typhic
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Cardiac disorders
Tachycardia at 100beats/min
|
5.0%
1/20 • Number of events 1 • 12 months
|
15.0%
3/20 • Number of events 3 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Temperature = 37.5C
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
General disorders
Thumb inflammation
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillitis
|
20.0%
4/20 • Number of events 4 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
|
Nervous system disorders
Torticollis
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Nervous system disorders
Transient loss of balance
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Traumatic leg wound
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Traumatic pain of left toes
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Traumatic wound of right ring fingure
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Traumatic wound of the middle finger
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Traumatic wound of the right knee
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Typhoid syndrome
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Uncomplicated malaria episode
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/20 • 12 months
|
10.0%
2/20 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
25.0%
5/20 • Number of events 5 • 12 months
|
|
Nervous system disorders
Vertigo
|
10.0%
2/20 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Viral rhinopharyngitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Visual floaters
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Vulvitis
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Reproductive system and breast disorders
Whitish leukorrhea
|
5.0%
1/20 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/20 • 12 months
|
0.00%
0/20 • 12 months
|
20.0%
4/20 • Number of events 4 • 12 months
|
Additional Information
Mahamadou A. Thera, MD, MPH, Professor
University of Bamako
Phone: 223-20-22-81-09
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place