Trial Outcomes & Findings for Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole (NCT NCT04311671)
NCT ID: NCT04311671
Last Updated: 2026-03-03
Results Overview
Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12979 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Moxidectin
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
|
Ivermectin
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); \> 159cm (4 x 3mg) tablets in capsules. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
|
Moxidectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
|
Ivermectin Plus Albendazole
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6421
|
1605
|
3959
|
994
|
|
Overall Study
COMPLETED
|
6395
|
1592
|
3891
|
977
|
|
Overall Study
NOT COMPLETED
|
26
|
13
|
68
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
Baseline characteristics by cohort
| Measure |
Moxidectin
n=6421 Participants
In onchocerciasis endemic areas: Moxidectin 8 mg per oral on Day 0 for adults and children from 8 years, 4 mg for children 4 to \< 8 years.
Moxidectin: 2 mg tablets, encapsulated for blinding
|
Ivermectin
n=1605 Participants
In onchocerciasis endemic areas: Ivermectin treatment with approximately 150 µg/kg per oral determined based on height on Day 0
Ivermectin: 3 mg tablets, encapsulated for blinding
|
Moxidectin With Concomitant Albendazole
n=3959 Participants
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Moxidectin 8 mg per oral for adults and children from 8 years, 4 mg for children 4 to \< 8 years, with concomitant albendazole 400 mg per oral on Day 0
Moxidectin: 2 mg tablets, encapsulated for blinding
Albendazole: 400 mg tablets
|
Ivermectin With Concomitant Albendazole
n=994 Participants
In onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity: Ivermectin treatment with approximately 150 microgram/kilogram (μg/kg) per oral determined based on height with concomitant albendazole 400 mg per oral on Day 0
Ivermectin: 3 mg tablets, encapsulated for blinding
Albendazole: 400 mg tablets
|
Total
n=12979 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2015 Participants
n=6421 Participants
|
461 Participants
n=1605 Participants
|
1387 Participants
n=3959 Participants
|
340 Participants
n=994 Participants
|
4203 Participants
n=12979 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4069 Participants
n=6421 Participants
|
1061 Participants
n=1605 Participants
|
2409 Participants
n=3959 Participants
|
610 Participants
n=994 Participants
|
8149 Participants
n=12979 Participants
|
|
Age, Categorical
>=65 years
|
337 Participants
n=6421 Participants
|
83 Participants
n=1605 Participants
|
163 Participants
n=3959 Participants
|
44 Participants
n=994 Participants
|
627 Participants
n=12979 Participants
|
|
Age, Continuous
|
30.4 years
n=6421 Participants
|
31.2 years
n=1605 Participants
|
28.5 years
n=3959 Participants
|
28.6 years
n=994 Participants
|
29.8 years
n=12979 Participants
|
|
Sex: Female, Male
Female
|
2954 Participants
n=6421 Participants
|
724 Participants
n=1605 Participants
|
1829 Participants
n=3959 Participants
|
470 Participants
n=994 Participants
|
5977 Participants
n=12979 Participants
|
|
Sex: Female, Male
Male
|
3467 Participants
n=6421 Participants
|
881 Participants
n=1605 Participants
|
2130 Participants
n=3959 Participants
|
524 Participants
n=994 Participants
|
7002 Participants
n=12979 Participants
|
|
Race/Ethnicity, Customized
Race - Black African
|
6421 participants
n=6421 Participants
|
1605 participants
n=1605 Participants
|
3959 participants
n=3959 Participants
|
994 participants
n=994 Participants
|
12979 participants
n=12979 Participants
|
|
Region of Enrollment
Congo, The Democratic Republic of the
|
6421 participants
n=6421 Participants
|
1605 participants
n=1605 Participants
|
0 participants
n=3959 Participants
|
0 participants
n=994 Participants
|
8026 participants
n=12979 Participants
|
|
Region of Enrollment
Côte D'Ivoire
|
0 participants
n=6421 Participants
|
0 participants
n=1605 Participants
|
3959 participants
n=3959 Participants
|
994 participants
n=994 Participants
|
4953 participants
n=12979 Participants
|
|
Number of Participants with Onchocerca volvulus skin microfilariae (mf)
Overall tested
|
6271 participants
n=6271 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
1568 participants
n=1568 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
3282 participants
n=3282 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
826 participants
n=826 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
11947 participants
n=11947 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
|
Number of Participants with Onchocerca volvulus skin microfilariae (mf)
Undetectable (skin mf =0)
|
6065 participants
n=6271 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
1509 participants
n=1568 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
3067 participants
n=3282 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
751 participants
n=826 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
11392 participants
n=11947 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
|
Number of Participants with Onchocerca volvulus skin microfilariae (mf)
Detectable (skin mf>0)
|
206 participants
n=6271 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
59 participants
n=1568 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
215 participants
n=3282 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
75 participants
n=826 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
555 participants
n=11947 Participants • Only participants 12 years and older had skin microfilariae (mf) measured, hence the total number of participants assessed as having undetectable or detectable skin mf (n=11947) is less than the overall study population (n=12979), a difference of 1032 (children under 12 years)
|
|
Number of participants with LF antigenemia and/or microfilaremia
CFA Positive (Category 1-3) with or without microfilaremia
|
—
|
—
|
107 participants
n=3286 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
23 participants
n=826 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
130 participants
n=4112 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
|
Number of participants with LF antigenemia and/or microfilaremia
CFA negative
|
—
|
—
|
3179 participants
n=3286 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
803 participants
n=826 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
3982 participants
n=4112 Participants • This assessment was only conducted in the Cote D'Ivoire region where LF was was known to be endemicand only in participants aged 12 years and older. Hence only participants in the Moxidectin plus Albendazole or the Ivermectin plus Albendazole arms have results for this measure
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Participants who received a single dose of moxidectin or ivermectin and participants who received a single dose of moxidectin or ivermectin with albendazole analyzed separately by endemic area and pooled.
Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis.
Outcome measures
| Measure |
Ivermectin
n=1605 Participants
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); \> 159cm (4 x 3mg) tablets in capsules. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
|
Moxidectin
n=6421 Participants
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
|
Moxidectin Plus Albendazole
n=3959 Participants
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
|
Ivermectin Plus Albendazole
n=994 Participants
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
|
Moxidectin +/- Albendazole (Pooled)
n=10380 Participants
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin, depending on LF-endemicity in the area
|
Ivermectin +/- Albendazole (Pooled)
n=2599 Participants
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin, depending on LF-endemicity in the area
|
|---|---|---|---|---|---|---|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with one or more Treatment Emergent Adverse Events (TEAEs)
|
79 participants
|
346 participants
|
1199 participants
|
288 participants
|
1545 participants
|
367 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with one or more TEAEs defined as a Mazzotti Reaction
|
47 participants
|
173 participants
|
455 participants
|
98 participants
|
628 participants
|
145 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with Severe (Gr 3 or 4) TEAE
|
5 participants
|
18 participants
|
66 participants
|
14 participants
|
84 participants
|
19 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with TEAE defined as Serious
|
4 participants
|
18 participants
|
4 participants
|
0 participants
|
22 participants
|
4 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with TEAE leading to Death
|
2 participants
|
6 participants
|
3 participants
|
0 participants
|
9 participants
|
2 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with a TEAE considered Related to Moxidectin or Ivermectin
|
50 participants
|
189 participants
|
576 participants
|
128 participants
|
765 participants
|
178 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with a Severe TEAE considered Related to Moxidectin or Ivermectin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with a TEAE considered Related to Albendazole
|
0 participants
|
0 participants
|
34 participants
|
7 participants
|
34 participants
|
7 participants
|
|
Incidence and Severity of Treatment Emergent Adverse Events
Number of Participants with a Severe TEAE considered Related to Albendazole
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Moxidectin
Serious events: 18 serious events
Other events: 346 other events
Deaths: 6 deaths
Ivermectin
Serious events: 4 serious events
Other events: 79 other events
Deaths: 2 deaths
Moxidectin Plus Albendazole
Serious events: 4 serious events
Other events: 1199 other events
Deaths: 3 deaths
Ivermectin Plus Albendazole
Serious events: 0 serious events
Other events: 288 other events
Deaths: 0 deaths
Moxidectin +/- Albendazole (Pooled)
Serious events: 22 serious events
Other events: 1545 other events
Deaths: 9 deaths
Ivermectin +/- Albendazole (Pooled)
Serious events: 4 serious events
Other events: 367 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Moxidectin
n=6421 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
|
Ivermectin
n=1605 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); \> 159cm (4 x 3mg) tablets in capsules. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
|
Moxidectin Plus Albendazole
n=3959 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
|
Ivermectin Plus Albendazole
n=994 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
|
Moxidectin +/- Albendazole (Pooled)
n=10380 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin, depending on LF-endemicity in the area
|
Ivermectin +/- Albendazole (Pooled)
n=2599 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin, depending on LF-endemicity in the area
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
0.03%
2/6421 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.02%
2/10380 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Cardiac disorders
Myocardial infarction
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/10380 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Gastritis hemorrhagic
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/10380 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Joint abscess
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Complicated malaria or malaria
|
0.06%
4/6421 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Giardiasis
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Pneumonia
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.02%
2/10380 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Septic shock
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Reproductive system and breast disorders
Fournier's gangrene
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Surgical and medical procedures
Cataract operation
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Surgical and medical procedures
Leg amputation
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Vascular disorders
Gangrene
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/10380 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
Other adverse events
| Measure |
Moxidectin
n=6421 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets.
|
Ivermectin
n=1605 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single dose of ivermectin of approximately 150mcg/kg, estimated by height, administered as 3mg ivermectin tablet-in-capsules plus placebo to match (total 4 capsules): Height 90-119cm (1 x 3mg); 120 to 139cm (2 x 3mg); 140 to 159cm (3 x 3mg); \> 159cm (4 x 3mg) tablets in capsules. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in assessment of participants.
|
Moxidectin Plus Albendazole
n=3959 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin.
|
Ivermectin Plus Albendazole
n=994 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. All participants received a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin.
|
Moxidectin +/- Albendazole (Pooled)
n=10380 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with moxidectin, depending on LF-endemicity in the area
|
Ivermectin +/- Albendazole (Pooled)
n=2599 participants at risk
Participants randomized in a blinded fashion to this group received treatment with a single oral dose of moxidectin as 4 x 2mg tablet-in-capsules for adults and children from 8 years. Children \< 12 years received the required number of tablets removed from the capsules and without placebo, administered by an unblinded pharmacist or staff member not involved in the outcomes assessment of participants. Children aged 4 to less than 8 years received treatment with 2 x 2mg moxidectin tablets. Participants received treatment with or without a single Albendazole tablet 400mg as a single open label dose concurrently with ivermectin, depending on LF-endemicity in the area
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia or Palpitations
|
0.08%
5/6421 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.18%
7/3959 • Number of events 7 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
12/10380 • Number of events 12 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
4/6421 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.05%
2/3959 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
6/10380 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.15%
6/3959 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
6/10380 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Blood and lymphatic system disorders
Anemia
|
0.03%
2/6421 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
10/3959 • Number of events 10 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
12/10380 • Number of events 12 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Eye disorders
Conjunctival/ocular hyperemia or conjunctivitis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.35%
14/3959 • Number of events 14 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
14/10380 • Number of events 14 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Eye disorders
Eye pain
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.23%
9/3959 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
10/10380 • Number of events 10 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Eye disorders
Eye pruritis
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.63%
25/3959 • Number of events 27 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.70%
7/994 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.24%
25/10380 • Number of events 27 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.27%
7/2599 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Eye disorders
Lacrimation increased
|
0.03%
2/6421 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.05%
2/3959 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Abdominal pain and/or distension
|
0.17%
11/6421 • Number of events 11 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.6%
62/3959 • Number of events 62 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.0%
20/994 • Number of events 20 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.70%
73/10380 • Number of events 73 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.77%
20/2599 • Number of events 20 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Diarrhea
|
0.11%
7/6421 • Number of events 7 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
2/1605 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.4%
57/3959 • Number of events 60 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.6%
16/994 • Number of events 16 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.62%
64/10380 • Number of events 67 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.69%
18/2599 • Number of events 18 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Constipation / Hemorrhoids
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
8/3959 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
8/10380 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
6/6421 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
6/10380 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
3/3959 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
3/10380 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
0.09%
6/6421 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
2/1605 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
10/3959 • Number of events 10 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
12/10380 • Number of events 12 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
General disorders
Fatigue or Asthenia
|
0.08%
5/6421 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
4/1605 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.53%
21/3959 • Number of events 22 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.50%
5/994 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
26/10380 • Number of events 27 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.35%
9/2599 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
4/3959 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
General disorders
Influenza-like illness, chills or pyrexia
|
0.03%
2/6421 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.96%
38/3959 • Number of events 38 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.80%
8/994 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.39%
40/10380 • Number of events 40 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.31%
8/2599 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
General disorders
Chest pain
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
5/3959 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
6/10380 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
General disorders
Pain
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.71%
28/3959 • Number of events 28 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
3/994 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.27%
28/10380 • Number of events 28 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
General disorders
Peripheral swelling / swelling
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.83%
33/3959 • Number of events 34 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.91%
9/994 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.32%
33/10380 • Number of events 34 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.35%
9/2599 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Malaria / complicated malaria
|
0.78%
50/6421 • Number of events 51 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.56%
9/1605 • Number of events 10 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
5.9%
232/3959 • Number of events 243 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
6.6%
66/994 • Number of events 71 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.7%
282/10380 • Number of events 294 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.9%
75/2599 • Number of events 81 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Infections and infestations
Infections (various, not malaria)
|
0.37%
24/6421 • Number of events 24 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
4/1605 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.2%
89/3959 • Number of events 98 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.6%
16/994 • Number of events 16 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.1%
113/10380 • Number of events 122 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.77%
20/2599 • Number of events 20 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Injury, poisoning and procedural complications
Injuries
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.06%
1/1605 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.56%
22/3959 • Number of events 23 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.70%
7/994 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.22%
23/10380 • Number of events 24 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.31%
8/2599 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Metabolism and nutrition disorders
Appetite - disorder / decreased
|
0.03%
2/6421 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
2/1605 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.05%
2/3959 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.11%
7/6421 • Number of events 7 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.43%
17/3959 • Number of events 17 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.50%
5/994 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.23%
24/10380 • Number of events 24 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.19%
5/2599 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Back or neck pain
|
0.06%
4/6421 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
2/1605 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.83%
33/3959 • Number of events 34 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.60%
6/994 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.36%
37/10380 • Number of events 38 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.31%
8/2599 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling / limb discomfort
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
3/3959 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
3/10380 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia / musculoskeletal stiffness
|
0.14%
9/6421 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
2/1605 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.99%
39/3959 • Number of events 39 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.70%
7/994 • Number of events 7 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.46%
48/10380 • Number of events 48 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.35%
9/2599 • Number of events 9 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.01%
1/10380 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
12/3959 • Number of events 12 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
3/994 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
13/10380 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Nervous system disorders
Dizziness
|
0.09%
6/6421 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
4/1605 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.28%
11/3959 • Number of events 11 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
3/994 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.16%
17/10380 • Number of events 17 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.27%
7/2599 • Number of events 7 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Nervous system disorders
Headache
|
1.3%
84/6421 • Number of events 84 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.3%
21/1605 • Number of events 21 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
4.1%
161/3959 • Number of events 168 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
5.4%
54/994 • Number of events 55 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.4%
245/10380 • Number of events 252 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
2.9%
75/2599 • Number of events 76 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Nervous system disorders
Sciatica, parasthesia, blurred vision
|
0.05%
3/6421 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.33%
13/3959 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.15%
16/10380 • Number of events 16 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
3/3959 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
3/994 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
3/10380 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.12%
3/2599 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough / Asthma
|
0.23%
15/6421 • Number of events 15 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.19%
3/1605 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.93%
37/3959 • Number of events 38 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.80%
8/994 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.50%
52/10380 • Number of events 53 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.42%
11/2599 • Number of events 11 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Reproductive system and breast disorders
Menstrual bleeding - heavy, inter, menometorrhagia
|
0.05%
3/6421 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.25%
10/3959 • Number of events 10 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
13/10380 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
2/2599 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
5/3959 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.05%
5/10380 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis / oropharangeal pain
|
0.02%
1/6421 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.30%
12/3959 • Number of events 12 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.50%
5/994 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
13/10380 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.19%
5/2599 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis, rhinorrhea
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
4/3959 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/994 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/2599 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Skin and subcutaneous tissue disorders
Pruritis / rash pruritic/ rash/ urticaria
|
1.4%
92/6421 • Number of events 92 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
1.4%
22/1605 • Number of events 22 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
9.1%
360/3959 • Number of events 367 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
6.7%
67/994 • Number of events 70 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
4.4%
452/10380 • Number of events 459 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
3.4%
89/2599 • Number of events 92 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Skin and subcutaneous tissue disorders
Other skin conditions >0.1%
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
4/3959 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
4/10380 • Number of events 4 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Vascular disorders
Hypertension
|
0.34%
22/6421 • Number of events 22 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.37%
6/1605 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
1/3959 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.20%
2/994 • Number of events 2 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.22%
23/10380 • Number of events 23 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.31%
8/2599 • Number of events 8 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Vascular disorders
Hypotension
|
0.20%
13/6421 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.31%
5/1605 • Number of events 5 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/3959 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.13%
13/10380 • Number of events 13 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.23%
6/2599 • Number of events 6 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
|
Vascular disorders
Other vascular disorders > 0.1%
|
0.00%
0/6421 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.00%
0/1605 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.08%
3/3959 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.10%
1/994 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.03%
3/10380 • Number of events 3 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
0.04%
1/2599 • Number of events 1 • Adverse events were collected for all participants daily for 5 days and up to 3 months after treatment. More than 98% of participants completed a Month 3 visit.
Adverse events were recorded by the Investigator and may have been initially recorded at a local health center a participant choose to attend or by a study team member during the protocol scheduled follow up visits or ad hoc visits at the request of a participant.
|
Additional Information
Amanda Handley
Medicines Development for Global Health
Phone: +61 (0)438 367 239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor requires that the study results be published in their entirety prior to a PI presenting, publishing or otherwise communicating study results for an individual site
- Publication restrictions are in place
Restriction type: OTHER