Trial Outcomes & Findings for Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali (NCT NCT03917654)
NCT ID: NCT03917654
Last Updated: 2024-10-22
Results Overview
Number of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1301 participants
Primary outcome timeframe
Within 7 days after each vaccination at days, 0, 28, 126, 448 (for arms 1a, 1b, 2a, 2b), days 0, 28, 56, 392 (for arms 3a, 3b, 3c, 3d, 3e, 3f), days -14 and 385 (for arms 4a, 4b) and year 2 (for all arms)
Results posted on
2024-10-22
Participant Flow
Participant milestones
| Measure |
Arm 1a
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1
STARTED
|
15
|
15
|
15
|
15
|
99
|
87
|
192
|
177
|
227
|
267
|
97
|
95
|
|
Year 1
COMPLETED
|
14
|
13
|
13
|
15
|
94
|
82
|
173
|
162
|
218
|
257
|
92
|
87
|
|
Year 1
NOT COMPLETED
|
1
|
2
|
2
|
0
|
5
|
5
|
19
|
15
|
9
|
10
|
5
|
8
|
|
Year 2
STARTED
|
13
|
10
|
13
|
14
|
86
|
77
|
152
|
147
|
199
|
238
|
90
|
87
|
|
Year 2
Did Not Rescreen
|
1
|
3
|
0
|
1
|
8
|
5
|
21
|
15
|
19
|
19
|
2
|
0
|
|
Year 2
COMPLETED
|
10
|
9
|
13
|
14
|
82
|
75
|
138
|
139
|
185
|
226
|
89
|
83
|
|
Year 2
NOT COMPLETED
|
3
|
1
|
0
|
0
|
4
|
2
|
14
|
8
|
14
|
12
|
1
|
4
|
Reasons for withdrawal
| Measure |
Arm 1a
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Year 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
6
|
2
|
5
|
3
|
1
|
0
|
|
Year 1
Travel
|
0
|
1
|
1
|
0
|
4
|
4
|
10
|
8
|
2
|
5
|
3
|
3
|
|
Year 1
Subject moved away from site
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
3
|
|
Year 1
Spouse/Family member request
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
|
Year 1
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Year 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Year 1
Missed visits
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Year 1
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Year 2
Travel
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
0
|
1
|
0
|
1
|
|
Year 2
Married
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Year 2
Subject moved away from site
|
1
|
0
|
0
|
0
|
1
|
0
|
2
|
3
|
0
|
2
|
0
|
1
|
|
Year 2
Year 2 Screening failure
|
0
|
1
|
0
|
0
|
2
|
0
|
4
|
3
|
10
|
2
|
1
|
1
|
|
Year 2
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Year 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
2
|
5
|
0
|
0
|
|
Year 2
Spouse/family member request
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Year 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Year 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Baseline characteristics by cohort
| Measure |
Arm 1a
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
n=99 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
n=87 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
n=192 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
n=177 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
n=227 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
n=267 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
n=97 Participants
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
n=95 Participants
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Total
n=1301 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
99 Participants
n=146 Participants
|
87 Participants
n=19 Participants
|
178 Participants
n=147 Participants
|
167 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
97 Participants
n=19 Participants
|
95 Participants
n=4 Participants
|
783 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
14 Participants
n=147 Participants
|
10 Participants
n=193 Participants
|
208 Participants
|
249 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
481 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
19 Participants
|
18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
37 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
50 Participants
n=146 Participants
|
43 Participants
n=19 Participants
|
84 Participants
n=147 Participants
|
91 Participants
n=193 Participants
|
126 Participants
|
147 Participants
|
44 Participants
n=19 Participants
|
43 Participants
n=4 Participants
|
653 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
49 Participants
n=146 Participants
|
44 Participants
n=19 Participants
|
108 Participants
n=147 Participants
|
86 Participants
n=193 Participants
|
101 Participants
|
120 Participants
|
53 Participants
n=19 Participants
|
52 Participants
n=4 Participants
|
648 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Bambara
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
51 Participants
n=146 Participants
|
34 Participants
n=19 Participants
|
84 Participants
n=147 Participants
|
51 Participants
n=193 Participants
|
115 Participants
|
139 Participants
|
41 Participants
n=19 Participants
|
32 Participants
n=4 Participants
|
575 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Sarakole
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
51 Participants
n=19 Participants
|
93 Participants
n=147 Participants
|
121 Participants
n=193 Participants
|
98 Participants
|
122 Participants
|
45 Participants
n=19 Participants
|
58 Participants
n=4 Participants
|
661 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Peulh
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
12 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
8 Participants
|
4 Participants
|
5 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
38 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
4 Participants
n=193 Participants
|
0 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Malinke
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=147 Participants
|
1 Participants
n=193 Participants
|
6 Participants
|
0 Participants
|
5 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Bozo
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Sonrhai
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Mali
|
15 participants
n=39 Participants
|
15 participants
n=41 Participants
|
15 participants
n=35 Participants
|
15 participants
n=31 Participants
|
99 participants
n=146 Participants
|
87 participants
n=19 Participants
|
192 participants
n=147 Participants
|
177 participants
n=193 Participants
|
227 participants
|
267 participants
|
97 participants
n=19 Participants
|
95 participants
n=4 Participants
|
1301 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after each vaccination at days, 0, 28, 126, 448 (for arms 1a, 1b, 2a, 2b), days 0, 28, 56, 392 (for arms 3a, 3b, 3c, 3d, 3e, 3f), days -14 and 385 (for arms 4a, 4b) and year 2 (for all arms)Number of participants with local and systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine
Outcome measures
| Measure |
Arm 1a
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
n=15 Participants
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
n=99 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
n=87 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
n=192 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
n=177 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
n=227 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
n=267 Participants
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
n=97 Participants
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
n=95 Participants
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events in Years 1 and 2
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
96 Participants
|
85 Participants
|
187 Participants
|
172 Participants
|
224 Participants
|
260 Participants
|
89 Participants
|
85 Participants
|
Adverse Events
Arm 1a
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm 1b
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm 2a
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm 2b
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Arm 3a
Serious events: 1 serious events
Other events: 95 other events
Deaths: 0 deaths
Arm 3b
Serious events: 1 serious events
Other events: 84 other events
Deaths: 1 deaths
Arm 3c
Serious events: 0 serious events
Other events: 187 other events
Deaths: 0 deaths
Arm 3d
Serious events: 2 serious events
Other events: 170 other events
Deaths: 0 deaths
Arm 3e
Serious events: 2 serious events
Other events: 222 other events
Deaths: 2 deaths
Arm 3f
Serious events: 7 serious events
Other events: 253 other events
Deaths: 5 deaths
Arm 4a
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
Arm 4b
Serious events: 1 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1a
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
n=99 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
n=87 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
n=192 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
n=177 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
n=227 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
n=267 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
n=97 participants at risk
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
n=95 participants at risk
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Blood Creatinine Increased
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Drowning
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
ESOPHAGEAL STENOSIS
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Malaria
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Pancreatic carcinoma
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Reproductive system and breast disorders
Prostate adenoma
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Struck by lightning
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
Other adverse events
| Measure |
Arm 1a
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses of 40 μg of Pfs230D1M-EPA/AS01 administered via intramuscular (IM) injection on days: 0, 28, 126, 448; receipt of artemether/lumefantrine (AL) on day -7
|
Arm 1b
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 28 to receove TYPHIM Vi; and day 126 to receive Menactra; receipt of AL on day -7
|
Arm 2a
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 126, 448 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7,112, 441
|
Arm 2b
n=15 participants at risk
Pilot/safety: Dosing interval on days: 0, 28, 126, 448
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 448 to receive HAVRIX; day 126 to receive Menactra; receipt of AL on day -7,112, 441
|
Arm 3a
n=99 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7, 42, 385
|
Arm 3b
n=87 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7, 42, 385
|
Arm 3c
n=192 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3d
n=177 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 3e
n=227 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 28, 56, 392 to receive 40 μg of Pfs230D1M-EPA/AS01; receipt of AL on day -7
|
Arm 3f
n=267 participants at risk
Safety/efficacy: Dosing interval on days 0, 28, 56, 392
Participants received 4 doses administered via intramuscular (IM) injection on days 0, 392 to receive HAVRIX; day 28 TYPHIM Vi; day 56 to receive Menactra; receipt of AL on day -7
|
Arm 4a
n=97 participants at risk
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
Arm 4b
n=95 participants at risk
AL treatment only; no vaccination
Participants received AL on day -14, 385
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
13.3%
2/15 • Number of events 3 • 2 years
|
13.3%
2/15 • Number of events 4 • 2 years
|
15.2%
15/99 • Number of events 18 • 2 years
|
21.8%
19/87 • Number of events 25 • 2 years
|
12.5%
24/192 • Number of events 26 • 2 years
|
13.6%
24/177 • Number of events 30 • 2 years
|
3.5%
8/227 • Number of events 8 • 2 years
|
6.0%
16/267 • Number of events 17 • 2 years
|
8.2%
8/97 • Number of events 9 • 2 years
|
6.3%
6/95 • Number of events 6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain Upper
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.88%
2/227 • Number of events 2 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Abscess
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Abscess limb
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
5.1%
5/99 • Number of events 5 • 2 years
|
5.7%
5/87 • Number of events 5 • 2 years
|
3.1%
6/192 • Number of events 7 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
3.5%
8/227 • Number of events 12 • 2 years
|
3.4%
9/267 • Number of events 9 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Vascular disorders
Arteritis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
3.1%
7/227 • Number of events 8 • 2 years
|
3.4%
9/267 • Number of events 9 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Arthropod sting
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 3 • 2 years
|
3.1%
7/227 • Number of events 7 • 2 years
|
3.0%
8/267 • Number of events 8 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
1.8%
4/227 • Number of events 5 • 2 years
|
2.2%
6/267 • Number of events 6 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Blood creatinine inreased
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
5.3%
12/227 • Number of events 15 • 2 years
|
8.2%
22/267 • Number of events 28 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 2 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
9.1%
9/99 • Number of events 10 • 2 years
|
14.9%
13/87 • Number of events 13 • 2 years
|
6.8%
13/192 • Number of events 13 • 2 years
|
5.6%
10/177 • Number of events 10 • 2 years
|
9.3%
21/227 • Number of events 24 • 2 years
|
5.2%
14/267 • Number of events 14 • 2 years
|
9.3%
9/97 • Number of events 10 • 2 years
|
14.7%
14/95 • Number of events 19 • 2 years
|
|
General disorders
Chest pain
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Chills
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
2.1%
4/192 • Number of events 6 • 2 years
|
2.8%
5/177 • Number of events 5 • 2 years
|
4.0%
9/227 • Number of events 9 • 2 years
|
4.9%
13/267 • Number of events 13 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Circumcision
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
4.0%
4/99 • Number of events 4 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
2.1%
2/95 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Number of events 3 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
6.1%
6/99 • Number of events 6 • 2 years
|
4.6%
4/87 • Number of events 4 • 2 years
|
8.9%
17/192 • Number of events 20 • 2 years
|
3.4%
6/177 • Number of events 6 • 2 years
|
2.6%
6/227 • Number of events 6 • 2 years
|
5.2%
14/267 • Number of events 15 • 2 years
|
6.2%
6/97 • Number of events 6 • 2 years
|
4.2%
4/95 • Number of events 4 • 2 years
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.6%
3/192 • Number of events 3 • 2 years
|
2.3%
4/177 • Number of events 4 • 2 years
|
7.9%
18/227 • Number of events 20 • 2 years
|
7.5%
20/267 • Number of events 22 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
2.6%
5/192 • Number of events 7 • 2 years
|
4.0%
7/177 • Number of events 8 • 2 years
|
5.3%
12/227 • Number of events 14 • 2 years
|
5.2%
14/267 • Number of events 14 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatosis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
1.3%
3/227 • Number of events 3 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
2.1%
2/97 • Number of events 2 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
2.1%
4/192 • Number of events 4 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
6.2%
14/227 • Number of events 15 • 2 years
|
6.0%
16/267 • Number of events 19 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Dysentery
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
4.0%
9/227 • Number of events 9 • 2 years
|
5.2%
14/267 • Number of events 14 • 2 years
|
2.1%
2/97 • Number of events 2 • 2 years
|
0.00%
0/95 • 2 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Ear infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
2.0%
2/99 • Number of events 3 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erysipelas
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.00%
0/177 • 2 years
|
5.7%
13/227 • Number of events 13 • 2 years
|
1.5%
4/267 • Number of events 4 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Food poisoning
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
0.00%
0/227 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Forearm fracture
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Ear and labyrinth disorders
Foreign body in ear
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Fungal infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Fungal skin infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
1.3%
3/227 • Number of events 3 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 2 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
0.00%
0/15 • 2 years
|
8.1%
8/99 • Number of events 8 • 2 years
|
10.3%
9/87 • Number of events 11 • 2 years
|
5.2%
10/192 • Number of events 10 • 2 years
|
7.3%
13/177 • Number of events 14 • 2 years
|
7.9%
18/227 • Number of events 20 • 2 years
|
8.2%
22/267 • Number of events 25 • 2 years
|
12.4%
12/97 • Number of events 13 • 2 years
|
10.5%
10/95 • Number of events 11 • 2 years
|
|
Infections and infestations
Genital infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
1.9%
5/267 • Number of events 5 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • Number of events 15 • 2 years
|
26.7%
4/15 • Number of events 6 • 2 years
|
46.7%
7/15 • Number of events 7 • 2 years
|
0.00%
0/15 • 2 years
|
24.2%
24/99 • Number of events 29 • 2 years
|
6.9%
6/87 • Number of events 9 • 2 years
|
40.1%
77/192 • Number of events 117 • 2 years
|
26.0%
46/177 • Number of events 69 • 2 years
|
52.0%
118/227 • Number of events 182 • 2 years
|
37.5%
100/267 • Number of events 161 • 2 years
|
4.1%
4/97 • Number of events 4 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
3.0%
3/99 • Number of events 3 • 2 years
|
3.4%
3/87 • Number of events 5 • 2 years
|
2.6%
5/192 • Number of events 7 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
2.6%
6/227 • Number of events 9 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Eye disorders
Hordeolum
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Infection parasitic
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Immune system disorders
Inflammation
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Injection site edema
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Injection site induration
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Injection site movement impairment
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Injection site pain
|
100.0%
15/15 • Number of events 37 • 2 years
|
73.3%
11/15 • Number of events 21 • 2 years
|
100.0%
15/15 • Number of events 31 • 2 years
|
80.0%
12/15 • Number of events 19 • 2 years
|
80.8%
80/99 • Number of events 148 • 2 years
|
52.9%
46/87 • Number of events 74 • 2 years
|
77.1%
148/192 • Number of events 247 • 2 years
|
44.1%
78/177 • Number of events 105 • 2 years
|
67.0%
152/227 • Number of events 245 • 2 years
|
31.8%
85/267 • Number of events 106 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Injection site pruritis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Injection site swelling
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Layrngitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
13.3%
2/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
3.4%
3/87 • Number of events 3 • 2 years
|
2.6%
5/192 • Number of events 6 • 2 years
|
1.7%
3/177 • Number of events 5 • 2 years
|
2.6%
6/227 • Number of events 7 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
2/15 • Number of events 3 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
6.9%
6/87 • Number of events 6 • 2 years
|
7.8%
15/192 • Number of events 22 • 2 years
|
11.3%
20/177 • Number of events 25 • 2 years
|
12.3%
28/227 • Number of events 50 • 2 years
|
15.0%
40/267 • Number of events 61 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.88%
2/227 • Number of events 2 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Lip swelling
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Malaria
|
86.7%
13/15 • Number of events 31 • 2 years
|
73.3%
11/15 • Number of events 21 • 2 years
|
66.7%
10/15 • Number of events 26 • 2 years
|
66.7%
10/15 • Number of events 16 • 2 years
|
70.7%
70/99 • Number of events 155 • 2 years
|
70.1%
61/87 • Number of events 128 • 2 years
|
77.1%
148/192 • Number of events 316 • 2 years
|
67.8%
120/177 • Number of events 241 • 2 years
|
45.8%
104/227 • Number of events 149 • 2 years
|
51.3%
137/267 • Number of events 184 • 2 years
|
49.5%
48/97 • Number of events 81 • 2 years
|
48.4%
46/95 • Number of events 69 • 2 years
|
|
Gastrointestinal disorders
Malnutrition
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Reproductive system and breast disorders
Mastitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
1.5%
4/267 • Number of events 4 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
7.5%
17/227 • Number of events 18 • 2 years
|
6.0%
16/267 • Number of events 22 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
13.3%
2/15 • Number of events 2 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
16.2%
16/99 • Number of events 18 • 2 years
|
12.6%
11/87 • Number of events 11 • 2 years
|
6.2%
12/192 • Number of events 12 • 2 years
|
4.5%
8/177 • Number of events 8 • 2 years
|
5.7%
13/227 • Number of events 15 • 2 years
|
4.1%
11/267 • Number of events 11 • 2 years
|
16.5%
16/97 • Number of events 19 • 2 years
|
8.4%
8/95 • Number of events 9 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
2.2%
5/227 • Number of events 5 • 2 years
|
2.2%
6/267 • Number of events 7 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
3/15 • Number of events 7 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
20.0%
3/15 • Number of events 5 • 2 years
|
4.0%
4/99 • Number of events 5 • 2 years
|
12.6%
11/87 • Number of events 12 • 2 years
|
10.4%
20/192 • Number of events 33 • 2 years
|
18.6%
33/177 • Number of events 41 • 2 years
|
16.7%
38/227 • Number of events 59 • 2 years
|
19.9%
53/267 • Number of events 84 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
2.0%
2/99 • Number of events 2 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
1.6%
3/192 • Number of events 3 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
1.3%
3/227 • Number of events 4 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
2.0%
2/99 • Number of events 2 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
3.2%
3/95 • Number of events 3 • 2 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Ear and labyrinth disorders
Parotitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Pharyngitis
|
26.7%
4/15 • Number of events 5 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
46.7%
7/15 • Number of events 9 • 2 years
|
46.7%
7/15 • Number of events 14 • 2 years
|
30.3%
30/99 • Number of events 43 • 2 years
|
33.3%
29/87 • Number of events 38 • 2 years
|
15.1%
29/192 • Number of events 35 • 2 years
|
20.3%
36/177 • Number of events 50 • 2 years
|
10.6%
24/227 • Number of events 26 • 2 years
|
7.5%
20/267 • Number of events 23 • 2 years
|
23.7%
23/97 • Number of events 29 • 2 years
|
26.3%
25/95 • Number of events 29 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.88%
2/227 • Number of events 2 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pyoderma
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Number of events 2 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
46.7%
7/15 • Number of events 9 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
29.3%
29/99 • Number of events 34 • 2 years
|
12.6%
11/87 • Number of events 13 • 2 years
|
18.8%
36/192 • Number of events 44 • 2 years
|
4.5%
8/177 • Number of events 10 • 2 years
|
15.0%
34/227 • Number of events 37 • 2 years
|
7.1%
19/267 • Number of events 19 • 2 years
|
16.5%
16/97 • Number of events 17 • 2 years
|
5.3%
5/95 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
66.7%
10/15 • Number of events 14 • 2 years
|
33.3%
5/15 • Number of events 8 • 2 years
|
53.3%
8/15 • Number of events 15 • 2 years
|
40.0%
6/15 • Number of events 13 • 2 years
|
57.6%
57/99 • Number of events 93 • 2 years
|
50.6%
44/87 • Number of events 76 • 2 years
|
52.1%
100/192 • Number of events 162 • 2 years
|
54.2%
96/177 • Number of events 149 • 2 years
|
45.4%
103/227 • Number of events 157 • 2 years
|
50.9%
136/267 • Number of events 211 • 2 years
|
57.7%
56/97 • Number of events 79 • 2 years
|
63.2%
60/95 • Number of events 96 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
1.0%
2/192 • Number of events 2 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.75%
2/267 • Number of events 2 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
1.8%
4/227 • Number of events 4 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinobronchitis
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
10.1%
10/99 • Number of events 10 • 2 years
|
3.4%
3/87 • Number of events 4 • 2 years
|
3.6%
7/192 • Number of events 8 • 2 years
|
5.6%
10/177 • Number of events 11 • 2 years
|
4.0%
9/227 • Number of events 10 • 2 years
|
5.2%
14/267 • Number of events 14 • 2 years
|
7.2%
7/97 • Number of events 8 • 2 years
|
4.2%
4/95 • Number of events 6 • 2 years
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.88%
2/227 • Number of events 2 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
1.3%
3/227 • Number of events 3 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Cardiac disorders
Tachycardia
|
20.0%
3/15 • Number of events 3 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 2 • 2 years
|
3.4%
3/87 • Number of events 4 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
4.1%
4/97 • Number of events 5 • 2 years
|
2.1%
2/95 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.44%
1/227 • Number of events 1 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Number of events 2 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.1%
6/99 • Number of events 7 • 2 years
|
4.6%
4/87 • Number of events 4 • 2 years
|
4.2%
8/192 • Number of events 8 • 2 years
|
2.8%
5/177 • Number of events 6 • 2 years
|
2.6%
6/227 • Number of events 8 • 2 years
|
3.4%
9/267 • Number of events 16 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Tonsilitis
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
0.00%
0/15 • 2 years
|
2.0%
2/99 • Number of events 2 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
0.00%
0/227 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
0.00%
0/87 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
3.0%
3/99 • Number of events 3 • 2 years
|
0.00%
0/87 • 2 years
|
0.52%
1/192 • Number of events 1 • 2 years
|
0.56%
1/177 • Number of events 1 • 2 years
|
0.00%
0/227 • 2 years
|
0.37%
1/267 • Number of events 1 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
13.3%
2/15 • Number of events 2 • 2 years
|
3.0%
3/99 • Number of events 3 • 2 years
|
2.3%
2/87 • Number of events 2 • 2 years
|
1.6%
3/192 • Number of events 4 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
0.88%
2/227 • Number of events 2 • 2 years
|
1.9%
5/267 • Number of events 5 • 2 years
|
0.00%
0/97 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
1.0%
1/99 • Number of events 1 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
2.1%
4/192 • Number of events 4 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
1.8%
4/227 • Number of events 4 • 2 years
|
2.2%
6/267 • Number of events 6 • 2 years
|
2.1%
2/97 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
|
Infections and infestations
Varicella
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/99 • 2 years
|
2.3%
2/87 • Number of events 2 • 2 years
|
0.00%
0/192 • 2 years
|
0.00%
0/177 • 2 years
|
0.00%
0/227 • 2 years
|
0.00%
0/267 • 2 years
|
0.00%
0/97 • 2 years
|
0.00%
0/95 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
20.0%
3/15 • Number of events 3 • 2 years
|
0.00%
0/15 • 2 years
|
4.0%
4/99 • Number of events 4 • 2 years
|
3.4%
3/87 • Number of events 3 • 2 years
|
3.1%
6/192 • Number of events 6 • 2 years
|
1.1%
2/177 • Number of events 2 • 2 years
|
3.1%
7/227 • Number of events 7 • 2 years
|
2.2%
6/267 • Number of events 6 • 2 years
|
3.1%
3/97 • Number of events 3 • 2 years
|
5.3%
5/95 • Number of events 5 • 2 years
|
|
Skin and subcutaneous tissue disorders
Wound
|
6.7%
1/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
4.0%
4/99 • Number of events 5 • 2 years
|
6.9%
6/87 • Number of events 6 • 2 years
|
2.6%
5/192 • Number of events 5 • 2 years
|
5.1%
9/177 • Number of events 10 • 2 years
|
2.2%
5/227 • Number of events 5 • 2 years
|
1.9%
5/267 • Number of events 5 • 2 years
|
0.00%
0/97 • 2 years
|
3.2%
3/95 • Number of events 3 • 2 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
0.00%
0/15 • 2 years
|
6.7%
1/15 • Number of events 1 • 2 years
|
3.0%
3/99 • Number of events 3 • 2 years
|
1.1%
1/87 • Number of events 1 • 2 years
|
2.6%
5/192 • Number of events 5 • 2 years
|
1.7%
3/177 • Number of events 3 • 2 years
|
1.3%
3/227 • Number of events 3 • 2 years
|
1.1%
3/267 • Number of events 3 • 2 years
|
1.0%
1/97 • Number of events 1 • 2 years
|
1.1%
1/95 • Number of events 1 • 2 years
|
Additional Information
Patrick E. Duffy
Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301.761.5089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place