Trial Outcomes & Findings for Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria (NCT NCT00331136)
NCT ID: NCT00331136
Last Updated: 2022-05-05
Results Overview
Clearance of asexual parasitaemia within 7 days of initiation of study medication without recrudescence within 28 days, without previously meeting any of the criteria for early treatment failure, late clinical failure, or late parasitological failure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Day 28
Results posted on
2022-05-05
Participant Flow
Participant milestones
| Measure |
Group A (Tablets)
Pyronaridine artesunate 6:2 mg/kg. Number of PA tablets (48 mg + 16 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group B (Tablets)
Pyronaridine artesunate 9:3 mg/kg. Number of PA tablets (72 mg + 24 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group C (Tablets)
Pyronaridine artesunate 12:4 mg/kg. Number of PA tablets (96 mg + 32 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group D (Granules)
Pyronaridine artesunate 9:3 mg/kg. Number of PA sachets containing granules (60 mg + 20 mg) administered based on posology. Sachet is administered as a suspension with water. 3-day course of once-daily dosing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
8
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group A (Tablets)
Pyronaridine artesunate 6:2 mg/kg. Number of PA tablets (48 mg + 16 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group B (Tablets)
Pyronaridine artesunate 9:3 mg/kg. Number of PA tablets (72 mg + 24 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group C (Tablets)
Pyronaridine artesunate 12:4 mg/kg. Number of PA tablets (96 mg + 32 mg) administered based on posology. 3-day course of once-daily dosing.
|
Group D (Granules)
Pyronaridine artesunate 9:3 mg/kg. Number of PA sachets containing granules (60 mg + 20 mg) administered based on posology. Sachet is administered as a suspension with water. 3-day course of once-daily dosing.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Not treated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Baseline characteristics by cohort
| Measure |
Group A (Tablets)
n=14 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=15 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=15 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
5.8 years
STANDARD_DEVIATION 2.19 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 3.48 • n=7 Participants
|
5.8 years
STANDARD_DEVIATION 2.60 • n=5 Participants
|
4.6 years
STANDARD_DEVIATION 1.96 • n=4 Participants
|
5.5 years
STANDARD_DEVIATION 2.62 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Height
|
110.4 cm
STANDARD_DEVIATION 13.16 • n=5 Participants
|
109.3 cm
STANDARD_DEVIATION 18.66 • n=7 Participants
|
111.8 cm
STANDARD_DEVIATION 16.08 • n=5 Participants
|
103.3 cm
STANDARD_DEVIATION 14.31 • n=4 Participants
|
108.7 cm
STANDARD_DEVIATION 15.67 • n=21 Participants
|
|
Weight
|
18.7 kg
STANDARD_DEVIATION 5.54 • n=5 Participants
|
18.8 kg
STANDARD_DEVIATION 7.00 • n=7 Participants
|
19.0 kg
STANDARD_DEVIATION 6.44 • n=5 Participants
|
16.5 kg
STANDARD_DEVIATION 5.15 • n=4 Participants
|
18.2 kg
STANDARD_DEVIATION 6.01 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
Clearance of asexual parasitaemia within 7 days of initiation of study medication without recrudescence within 28 days, without previously meeting any of the criteria for early treatment failure, late clinical failure, or late parasitological failure.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Percentage of Patients With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28
|
11 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
The time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance is defined as zero presence of parasites for 2 consecutive negative readings taken between 8 and 24 hours apart.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Parasite Clearance Time
|
16.4 hours
Interval 16.1 to 22.4
|
16.1 hours
Interval 8.3 to 16.4
|
8.1 hours
Interval 8.0 to 16.0
|
8.3 hours
Interval 8.1 to 15.9
|
SECONDARY outcome
Timeframe: Day 28Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
Treatment success for the ACPR analysis is defined as the clearance of asexual parasitaemia within 7 days of initiation of study medication without recrudescence within 28 days, without previously meeting any of the criteria for early treatment failure, late clinical failure, or late parasitological failure. Early and late failures are classified according to the WHO Protocol 2005.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Treatment Success or Failure
Treatment success
|
11 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
|
Treatment Success or Failure
Treatment failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 3Population: Only patients with a fever at baseline or within 24 hours were taken into account.
The time from first dosing to the first normal reading with fever clearance, defined as 2 consecutive assessments without fever (\<37.5°C) taken between 8 and 24 hours apart. NB: Time to fever clearance was only summarised for subjects who had fever at baseline or within the first 24 hours after the start of study treatment. Since only 12 subjects in total had fever during this time, the time to fever clearance estimates are not very meaningful.
Outcome measures
| Measure |
Group A (Tablets)
n=3 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=5 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=3 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=1 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Fever Clearance Time
|
8.2 hours
Interval 8.1 to 16.2
|
8.6 hours
Interval 8.1 to 17.2
|
8.2 hours
Interval 8.1 to 16.2
|
8.2 hours
Data available for only one participant, therefore, it is not possible to calculate the 95% Confidence Interval
|
SECONDARY outcome
Timeframe: Day 14Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
Clearance of asexual parasitaemia within 7 days of initiation of study medication without recrudescence within 14 days.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Number of Patients With PCR-corrected ACPR on Day 14
|
11 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 3Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
Zero presence of parasites for 2 consecutive negative readings taken between 8 and 24 hours apart.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Number of Patients With Parasite Clearance at Day 1, 2 and 3
Clearance by >48 - 72 hours (Day 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Parasite Clearance at Day 1, 2 and 3
Clearance by >0 - 24 hours (Day 1)
|
10 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
|
Number of Patients With Parasite Clearance at Day 1, 2 and 3
Clearance by >24 - 48 hours (Day 2)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Patients With Parasite Clearance at Day 1, 2 and 3
Clearance by >72 hours (Day 3 onwards)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Parasite Clearance at Day 1, 2 and 3
No clearance achieved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 42Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
The number of gametocytes per μl at Days 0, 3, 7, 14, 21, 28, 35, and 42 summarised from blood slides taken on the respective days. P. falciparum gametocytes are responsible for transmission from host to vector.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>Day 28 - Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
Baseline
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>0-24 hours
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>24-48 hours
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>48-72 hours
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>72 hours - Day 7
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>Day 7 - Day 28
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With P. Falciparum Gametocytes During the Trial
>Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2, 3Population: Only patients with a fever at baseline or within 24 hours were taken into account.
Patient without fever for 2 consecutive readings taken between 8 and 24 hours apart. NB: Percentage of fever clearance was only summarised for subjects who had fever at baseline or within the first 24 hours after the start of study treatment. Since only 12 subjects in total had fever during this time, the time to fever clearance estimates are not very meaningful.
Outcome measures
| Measure |
Group A (Tablets)
n=3 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=5 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=3 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=1 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Percentage of Patients With Fever Clearance at Day 1, 2 and 3
Clearance by >0 - 24 hours
|
3 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Percentage of Patients With Fever Clearance at Day 1, 2 and 3
Clearance by >24 - 48 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Patients With Fever Clearance at Day 1, 2 and 3
Clearance by >48 - 72 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Patients With Fever Clearance at Day 1, 2 and 3
No clearance achieved
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 14, 28, 42Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
The proportion of patients with crude (non-PCR corrected) ACPR.
Outcome measures
| Measure |
Group A (Tablets)
n=11 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=13 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Crude ACPR on Day 14, 28 and 42
Day 14
|
11 Participants
|
13 Participants
|
15 Participants
|
14 Participants
|
|
Crude ACPR on Day 14, 28 and 42
Day 28
|
11 Participants
|
10 Participants
|
15 Participants
|
14 Participants
|
|
Crude ACPR on Day 14, 28 and 42
Day 42
|
7 Participants
|
6 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 42Population: Per protocol population: all patients who received a full course of study treatment, had a known status of the primary efficacy variable, and did not have major protocol violations.
Clearance of asexual parasitaemia within 7 days of initiation of study medication without recrudescence within 42 days.
Outcome measures
| Measure |
Group A (Tablets)
n=10 Participants
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=9 Participants
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 Participants
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=14 Participants
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Number of Patients With PCR-corrected ACPR on Day 42
|
10 Participants
|
8 Participants
|
15 Participants
|
13 Participants
|
Adverse Events
Group A (Tablets)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Group B (Tablets)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group C (Tablets)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group D (Granules)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (Tablets)
n=14 participants at risk
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=15 participants at risk
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 participants at risk
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=15 participants at risk
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
|
General disorders
Pyrexia
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
|
Infections and infestations
Paronychia
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
Other adverse events
| Measure |
Group A (Tablets)
n=14 participants at risk
Pyronaridine artesunate 6:2 mg/kg
|
Group B (Tablets)
n=15 participants at risk
Pyronaridine artesunate 9:3 mg/kg
|
Group C (Tablets)
n=15 participants at risk
Pyronaridine artesunate 12:4 mg/kg
|
Group D (Granules)
n=15 participants at risk
Pyronaridine artesunate 9:3 mg/kg
|
|---|---|---|---|---|
|
Infections and infestations
Plasmodium falciparum infection
|
7.1%
1/14 • 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
|
40.0%
6/15 • 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
|
13.3%
2/15 • 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
|
13.3%
2/15 • 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
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
2/14 • 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
|
0.00%
0/15 • 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
|
20.0%
3/15 • 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
|
33.3%
5/15 • 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
|
|
Infections and infestations
Ascariasis
|
7.1%
1/14 • 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
|
6.7%
1/15 • 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
|
20.0%
3/15 • 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
|
6.7%
1/15 • 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
|
|
Infections and infestations
Malaria
|
28.6%
4/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/14 • 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
|
0.00%
0/15 • 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
|
13.3%
2/15 • 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
|
6.7%
1/15 • 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
|
|
Infections and infestations
Abscess
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
0.00%
0/15 • 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
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
13.3%
2/15 • 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
|
|
Infections and infestations
Giardiasis
|
0.00%
0/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
13.3%
2/15 • 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
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
13.3%
2/15 • 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
|
|
Infections and infestations
Schistosomiasis
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
0.00%
0/15 • 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
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
0.00%
0/15 • 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
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • 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
|
20.0%
3/15 • 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
|
6.7%
1/15 • 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
|
6.7%
1/15 • 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
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
0.00%
0/15 • 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
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • 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
|
6.7%
1/15 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
|
Nervous system disorders
Headache
|
35.7%
5/14 • 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
|
6.7%
1/15 • 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
|
13.3%
2/15 • 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
|
6.7%
1/15 • 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
|
|
General disorders
Fatigue
|
7.1%
1/14 • 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
|
13.3%
2/15 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
|
General disorders
Pyrexia
|
7.1%
1/14 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
13.3%
2/15 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • 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
|
6.7%
1/15 • 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
|
13.3%
2/15 • 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
|
6.7%
1/15 • 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
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/14 • 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
|
13.3%
2/15 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • 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
|
0.00%
0/15 • 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
|
0.00%
0/15 • 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
|
6.7%
1/15 • 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
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/14 • 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
|
0.00%
0/15 • 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
|
13.3%
2/15 • 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
|
0.00%
0/15 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place