Trial Outcomes & Findings for Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria (NCT NCT01594931)
NCT ID: NCT01594931
Last Updated: 2021-11-02
Results Overview
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
477 participants
Primary outcome timeframe
Day 28
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Overall Study
STARTED
|
160
|
157
|
160
|
|
Overall Study
COMPLETED
|
131
|
145
|
146
|
|
Overall Study
NOT COMPLETED
|
29
|
12
|
14
|
Reasons for withdrawal
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
No defiined
|
11
|
4
|
7
|
Baseline Characteristics
One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
Baseline characteristics by cohort
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=160 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=157 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=160 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 10.9 • n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
27.4 years
STANDARD_DEVIATION 10.9 • n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
28.9 years
STANDARD_DEVIATION 11.4 • n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
27.8 years
STANDARD_DEVIATION 11.1 • n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Sex: Female, Male
Female
|
43 Participants
n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
37 Participants
n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
40 Participants
n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
120 Participants
n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Sex: Female, Male
Male
|
117 Participants
n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
120 Participants
n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
119 Participants
n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
356 Participants
n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Race/Ethnicity, Customized
White/Caucasian
|
0 Participants
n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
0 Participants
n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
0 Participants
n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
0 Participants
n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Race/Ethnicity, Customized
Black
|
49 Participants
n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
47 Participants
n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
48 Participants
n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
144 Participants
n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
111 Participants
n=160 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
110 Participants
n=157 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
111 Participants
n=159 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
332 Participants
n=476 Participants • One subject, who was randomized to the 12+4 mg/kg dose group, did not receive any study medication and was excluded from all populations.
|
|
Region of Enrollment
Cambodia
|
10 participants
n=160 Participants
|
9 participants
n=157 Participants
|
10 participants
n=160 Participants
|
29 participants
n=477 Participants
|
|
Region of Enrollment
Senegal
|
32 participants
n=160 Participants
|
32 participants
n=157 Participants
|
30 participants
n=160 Participants
|
94 participants
n=477 Participants
|
|
Region of Enrollment
Gambia
|
12 participants
n=160 Participants
|
10 participants
n=157 Participants
|
13 participants
n=160 Participants
|
35 participants
n=477 Participants
|
|
Region of Enrollment
Uganda
|
5 participants
n=160 Participants
|
5 participants
n=157 Participants
|
6 participants
n=160 Participants
|
16 participants
n=477 Participants
|
|
Region of Enrollment
Thailand
|
80 participants
n=160 Participants
|
80 participants
n=157 Participants
|
80 participants
n=160 Participants
|
160 participants
n=477 Participants
|
|
Region of Enrollment
Indonesia
|
21 participants
n=160 Participants
|
21 participants
n=157 Participants
|
21 participants
n=160 Participants
|
63 participants
n=477 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=101 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=103 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=102 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
PCR-Corrected ACPR at Day 28
|
95 percentage of subjects
Interval 89.9 to 98.0
|
99 percentage of subjects
Interval 95.5 to 100.0
|
99 percentage of subjects
Interval 95.4 to 99.9
|
SECONDARY outcome
Timeframe: Day 14Population: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=105 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=107 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=106 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
PCR-Corrected ACPR at Day 14
|
100 percentage of subjects
Interval 97.2 to 100.0
|
100 percentage of subjects
Interval 97.2 to 100.0
|
100 percentage of subjects
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: Thick blood slides were examined every 8 hours until at least 72 hours or until a negative smear was recordedPopulation: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Parasite clearance time was defined as the time (in hours) from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of parasites for two consecutive negative readings eight hours apart, with confirmed negative reading at 24 hours after the first negative slide
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=108 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=109 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=109 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Parasite Clearance Time
|
36.9 hours
Standard Deviation 20.73
|
33.6 hours
Standard Deviation 17.08
|
30.8 hours
Standard Deviation 14.96
|
SECONDARY outcome
Timeframe: Every 8 hours for at least 72 hours after the first dosePopulation: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Fever clearance time was defined as the time (in hours) from first dosing to the first normal reading with fever clearance (2 consecutive assessments without fever (\<37.5°C)). The method of temperature measurement was the same (ie, axillary, tympanic, oral or rectal) for each subject. Any subjects with a documented history of fever at inclusion, but who did not subsequently have a documented temperature reading \>37.5°C during the 24 hours after initial dosing, were not included in this end point analysis.
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=84 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=93 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=93 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Fever Clearance Time
|
16.8 hours
Standard Deviation 12.75
|
24.0 hours
Standard Deviation 25.99
|
17.0 hours
Standard Deviation 12.90
|
SECONDARY outcome
Timeframe: Days 1, 2, and 3Population: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Parasite clearance is defined as zero presence of parasites for 2 consecutive negative readings 8 hours apart, with confirmed negative reading at 24 hours after the first negative slide. The proportion of subjects with parasite clearance was summarized at Days 1, 2, and 3.
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=108 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=109 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=109 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Parasite Clearance
Clearance rate (%) at Day 1 (24h after first dose)
|
74 percentage of subjects
Interval 64.8 to 82.0
|
82 percentage of subjects
Interval 73.1 to 88.4
|
84 percentage of subjects
Interval 76.2 to 90.6
|
|
Parasite Clearance
Clearance rate (%) at Day 2 (48h after first dose)
|
93 percentage of subjects
Interval 85.9 to 96.7
|
96 percentage of subjects
Interval 90.9 to 99.0
|
95 percentage of subjects
Interval 89.6 to 98.5
|
|
Parasite Clearance
Clearance rate (%) at Day 3 (72h after first dose)
|
96 percentage of subjects
Interval 90.8 to 99.0
|
98 percentage of subjects
Interval 93.5 to 99.8
|
99 percentage of subjects
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: Days 1, 2 and 3Population: Subjects meeting the following: completed a full course of study medication and had known efficacy endpoints; no missed dose due to vomiting (except at D0); no concom. medication, except acetaminophen; no concom. disease that could have interfered with treatment outcome; no major protocol violation with respect to entry eligibility criteria.
Fever clearance was defined as a subject without fever for 2 consecutive assessments, plus confirmed normal temperature at 24 hours. The proportion of subjects with fever clearance was summarized at Days 1, 2, and 3.
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=108 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=109 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=109 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Fever Clearance
Clearance rate (%) at Day 1 (24h after first dose)
|
96 percentage of subjects
Interval 90.8 to 99.0
|
91 percentage of subjects
Interval 83.8 to 95.5
|
96 percentage of subjects
Interval 90.9 to 99.0
|
|
Fever Clearance
Clearance rate (%) at Day 2 (48h after first dose)
|
99 percentage of subjects
Interval 94.9 to 100.0
|
96 percentage of subjects
Interval 90.9 to 99.0
|
100 percentage of subjects
Interval 96.7 to 100.0
|
|
Fever Clearance
Clearance rate (%) at Day 3 (72h after first dose)
|
99 percentage of subjects
Interval 94.9 to 100.0
|
96 percentage of subjects
Interval 90.9 to 99.0
|
100 percentage of subjects
Interval 96.7 to 100.0
|
SECONDARY outcome
Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlierPopulation: The safety population includes all subjects who were randomized and received any study medication, regardless of the amount.
An AE was defined as any unfavourable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study
Outcome measures
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=160 Participants
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=157 Participants
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=159 Participants
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Adverse Events (AEs)
Nr subj. with ≥1 AE
|
106 Participants
|
90 Participants
|
91 Participants
|
|
Adverse Events (AEs)
Nr subj. with ≥1 treatment-related AE
|
35 Participants
|
33 Participants
|
36 Participants
|
|
Adverse Events (AEs)
Nr subj. with ≥1 SAE
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs)
Nr subj. with ≥1 treatment-related SAE
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events (AEs)
Nr subj. with ≥1 AE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (AEs)
Nr subj. with ≥1 AE leading to study withdrawal
|
3 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
Serious events: 3 serious events
Other events: 106 other events
Deaths: 0 deaths
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=160 participants at risk
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=157 participants at risk
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=159 participants at risk
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Abscess Limb
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Malaria
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
Other adverse events
| Measure |
Group A: Pyronaridine/Artesunate (6:2 mg/kg)
n=160 participants at risk
Pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group B: Pyronaridine/Artesunate (9:3 mg/kg)
n=157 participants at risk
Pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
Group C: Pyronaridine/Artesunate (12:4 mg/kg)
n=159 participants at risk
Pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
Pyronaridine/artesunate: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
5/160 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
5.1%
8/157 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Nervous system disorders
Dizziness
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/157 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Nervous system disorders
Headache
|
13.8%
22/160 • Number of events 24 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
12.1%
19/157 • Number of events 21 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
10.7%
17/159 • Number of events 18 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
3/160 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
13/160 • Number of events 13 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
4.5%
7/157 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
8.2%
13/159 • Number of events 14 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
3/160 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Respiratory, thoracic and mediastinal disorders
Rash
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Blood alkaline phosphatase increased
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Eosinophil count increased
|
10.6%
17/160 • Number of events 18 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
8.9%
14/157 • Number of events 15 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
8.8%
14/159 • Number of events 14 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Transaminases increased
|
2.5%
4/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/157 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.8%
6/159 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
5/160 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.2%
5/157 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.8%
6/157 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Cardiac disorders
Bradycardia
|
6.2%
10/160 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
4.5%
7/157 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
5.0%
8/159 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
8/160 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.8%
6/157 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
3/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/157 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/160 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Nausea
|
2.5%
4/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/157 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Toothache
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
12/160 • Number of events 12 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
5.1%
8/157 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
5.0%
8/159 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
General disorders
Asthenia
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/157 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
General disorders
Chest pain
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/157 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
General disorders
Chills
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Congenital, familial and genetic disorders
Fatigue
|
1.9%
3/160 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/157 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Bronchitis
|
0.62%
1/160 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/157 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Malaria
|
7.5%
12/160 • Number of events 12 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
5.1%
8/157 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
4.4%
7/159 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/157 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.9%
3/159 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Otitis media acute
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Parasitic infection intestinal
|
2.5%
4/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/159 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Plasmodium falciparum infection
|
3.8%
6/160 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
7/160 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
2.5%
4/157 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
4.4%
7/159 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
4/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.8%
6/157 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.8%
6/159 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/160 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/157 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.64%
1/157 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
1.3%
2/159 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
16/160 • Number of events 16 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
9.6%
15/157 • Number of events 15 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
8.2%
13/159 • Number of events 13 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.8%
6/160 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
4.5%
7/157 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
3.1%
5/159 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
4/160 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.63%
1/159 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
|
Cardiac disorders
Arrhythmia
|
1.2%
2/160 • Number of events 2 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/157 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
0.00%
0/159 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
|
Additional Information
Stephan Duparc, MD, Chief Medical Officer
Medicines for Malaria Venture (MMV)
Phone: +41 22 555 0300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place