Trial Outcomes & Findings for To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria (NCT NCT04675931)
NCT ID: NCT04675931
Last Updated: 2026-04-09
Results Overview
A blood draw was performed at each collection time point for parasitemia assessment.
COMPLETED
PHASE2
254 participants
12 Hours
2026-04-09
Participant Flow
316 participants were screened for the study.
Participant milestones
| Measure |
IV Cipargamin 20 mg
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
116
|
118
|
|
Overall Study
COMPLETED
|
20
|
114
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
IV Cipargamin 20 mg
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Overall Study
Randomized but not Treated
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
Baseline characteristics by cohort
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
22.7 years
STANDARD_DEVIATION 10.07 • n=36 Participants
|
7.7 years
STANDARD_DEVIATION 7.81 • n=78 Participants
|
8.6 years
STANDARD_DEVIATION 9.13 • n=23 Participants
|
9.3 years
STANDARD_DEVIATION 9.47 • n=23 Participants
|
|
Age, Customized
6 months to < 2 years
|
0 Participants
n=36 Participants
|
21 Participants
n=78 Participants
|
18 Participants
n=23 Participants
|
39 Participants
n=23 Participants
|
|
Age, Customized
2 to <6 years
|
0 Participants
n=36 Participants
|
37 Participants
n=78 Participants
|
39 Participants
n=23 Participants
|
76 Participants
n=23 Participants
|
|
Age, Customized
6 to <12 years
|
0 Participants
n=36 Participants
|
38 Participants
n=78 Participants
|
40 Participants
n=23 Participants
|
78 Participants
n=23 Participants
|
|
Age, Customized
12 to <18 years
|
9 Participants
n=36 Participants
|
7 Participants
n=78 Participants
|
7 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
|
Age, Customized
18 to <65 years
|
11 Participants
n=36 Participants
|
11 Participants
n=78 Participants
|
13 Participants
n=23 Participants
|
35 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=36 Participants
|
49 Participants
n=78 Participants
|
64 Participants
n=23 Participants
|
122 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=36 Participants
|
65 Participants
n=78 Participants
|
53 Participants
n=23 Participants
|
129 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=36 Participants
|
114 Participants
n=78 Participants
|
117 Participants
n=23 Participants
|
251 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 12 HoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period.
A blood draw was performed at each collection time point for parasitemia assessment.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum) at 12 Hours
|
80.0 percentage of participants
|
93.0 percentage of participants
|
39.3 percentage of participants
|
SECONDARY outcome
Timeframe: 48 HoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period.
Clinical success was a composite endpoint based on following criteria: 1. Was participant dead or alive 2. Presence of asexual parasites (yes/no) 3. Presence of any of the key signs of severe malaria (yes/no)
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Success at 48 Hours
|
95.0 percentage of participants
Interval 78.4 to 99.7
|
85.1 percentage of participants
Interval 78.5 to 90.3
|
74.4 percentage of participants
Interval 66.9 to 80.9
|
SECONDARY outcome
Timeframe: Baseline to Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period.
Individual signs of severe malaria over time were monitored for the presence of the following signs of severe malaria during the entire study duration: 1. Altered consciousness - Prostration or GCS \< 11 for participants \> 5 years / BCS \< 3 for participants =\< 5 years of age 2. Renal Impairment - Serum creatinine \> 3xULN or \> 3 mg/dL or need for renal replacement therapy 3. Acidosis - Serum lactate \> 4 mmol/L 4. Respiratory distress - present or absent 5. Severe anemia - Hb \< 5 g/dl or Hb \< 7g/dl in pediatric and adults respectively or need of blood transfusion 6. Jaundice - Serum bilirubin \> 3 g/dl 7. Hypoglycemia- plasma glucose \< 40 mg/dL
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least One Sign
|
95.0 percentage of participants
|
98.2 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least Two Signs
|
35.0 percentage of participants
|
43.9 percentage of participants
|
45.3 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least Three Signs
|
10.0 percentage of participants
|
14.0 percentage of participants
|
17.9 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least Four Signs
|
0 percentage of participants
|
3.5 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least Five Signs
|
0 percentage of participants
|
0.9 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Baseline, at Least Six Signs
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Day 29, at Least One Sign
|
5.0 percentage of participants
|
6.2 percentage of participants
|
7.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 8 and Day 29Population: The safety set included all participants who took at least one dose of study drug during the treatment period. Number analyzed is the number of participants with available data.
Development (early and delayed) of hemolysis after treatments was defined as follows: Early Hemolytic anemia was defined as 10% or greater decrease in hemoglobin levels and an increase of lactate dehydrogenase (LDH) levels to \>390 U/L, or an increase of \>= 10% above baseline occurring up to Day 8 of the study. Delayed hemolytic anemia occurred \> 7 days after initiation of parenteral study drug (IV artesunate or IV cipargamin) during the study period. The event was characterized by a 10% or greater decrease in hemoglobin levels accompanied by increase of LDH levels to \>390 U/L, or an increase of \>= 10% compared to the values measured at Day 8 of the study.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants Developing Hemolysis (Early and Delayed) After Treatment
Early Hemolysis
|
55.0 percentage of participants
|
54.4 percentage of participants
|
62.1 percentage of participants
|
|
Percentage of Participants Developing Hemolysis (Early and Delayed) After Treatment
Delayed Hemolysis
|
5.0 percentage of participants
|
3.5 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with available data.
Detailed neurological examination was conducted and relevant medical history collected to assess the extent of neurological signs and symptoms at baseline and to monitor the extent of neurological sequelae in follow-up visits.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=113 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=115 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants With Neurological Sequelae at Day 29
Speech Impairment
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Neurological Sequelae at Day 29
Hemiplegia or Hemiparesis
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hours and 48 hoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period.
A blood draw was performed at each collection time point for parasitemia assessment.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum)
24 Hours Post-Dose
|
90.0 percentage of participants
|
100.0 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum)
48 Hours Post-Dose
|
100.0 percentage of participants
|
100.0 percentage of participants
|
99.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 72 hoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Parasite clearance time (PCT) was defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 24 hours.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=113 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=116 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time to Parasite Clearance (PCT)
|
21.1 hours
Interval 18.0 to 24.8
|
18.0 hours
Interval 12.2 to 18.2
|
36.0 hours
Interval 30.0 to 36.1
|
SECONDARY outcome
Timeframe: Up to 72 hoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Slope half-life (hours) for parasite clearance was calculated for each patient using the WWARN (World Wide Antimalarial Resistance Network) Parasite Clearance Estimator.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=108 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=114 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Parasite Clearance Estimator (PCE) Slope Half-life
|
1.63 hours
Interval 0.22 to 3.61
|
1.10 hours
Interval 0.27 to 10.03
|
2.21 hours
Interval 0.65 to 10.75
|
SECONDARY outcome
Timeframe: Up to 72 hoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Fever clearance time (FCT) was defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=7 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=28 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=39 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time to Fever Clearance (FCT)
|
6.2 hours
Interval 6.1 to 18.0
|
6.1 hours
Interval 0.6 to 11.7
|
17.8 hours
Interval 6.1 to 18.0
|
SECONDARY outcome
Timeframe: 12 hours, 24 hours, and 48 hoursPopulation: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time points.
PRR was defined as the ratio of asexual parasite at baseline divided by asexual parasite at post-baseline. If the asexual parasite count at post-baseline was 0, the half value of detection limit was used to calculate the ratio.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=116 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
P. Falciparum Parasite Reduction Ratios (PRR) at 12, 24 and 48 Hours
24 Hours n=20,114,116
|
3772.6 ratio
Interval 4.8 to 18744.9
|
4092.5 ratio
Interval 25.1 to 48092.3
|
560.6 ratio
Interval 4.7 to 25525.9
|
|
P. Falciparum Parasite Reduction Ratios (PRR) at 12, 24 and 48 Hours
12 Hours n=20,114,116
|
203.2 ratio
Interval 1.4 to 8737.4
|
1347.8 ratio
Interval 2.4 to 48092.3
|
7.5 ratio
Interval 1.0 to 9582.8
|
|
P. Falciparum Parasite Reduction Ratios (PRR) at 12, 24 and 48 Hours
48 Hours n=20,113,116
|
6220.5 ratio
Interval 560.6 to 31097.8
|
7175.1 ratio
Interval 292.0 to 51495.5
|
5509.1 ratio
Interval 58.1 to 72470.1
|
SECONDARY outcome
Timeframe: Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Recrudescence was defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Reinfection was defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection and Recrudescence were confirmed by polymerase chain reaction (PCR) analysis.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=112 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=114 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Percentage of Participants With Recrudescence and Reinfection
Recrudescence
|
0 percentage of participants
|
2.7 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Recrudescence and Reinfection
Reinfection
|
0 percentage of participants
|
8.0 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 3 to Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Time to switch participants from IV therapy to Coartem (standard of drug for oral therapy) was analyzed.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time to Switch to Oral Therapy
|
43.9 hours
Interval 41.6 to 46.9
|
43.3 hours
Interval 42.3 to 44.2
|
44.4 hours
Interval 43.6 to 44.9
|
SECONDARY outcome
Timeframe: Day 3 to Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=116 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time to Discharge From Hospital
|
73.2 hours
Interval 73.0 to 73.6
|
73.1 hours
Interval 72.9 to 73.2
|
73.1 hours
Interval 72.9 to 73.1
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period. Number analyzed is the number of participants with data available at the specified time point.
To assess recovery of participants as measured by time to recovery from prostration compared to baseline.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=19 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=109 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=116 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time to Recover From Prostration
|
18.2 hours
Interval 12.3 to 24.4
|
12.4 hours
Interval 12.1 to 18.2
|
18.3 hours
Interval 17.8 to 23.7
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: The safety set included all participants who took at least one dose of study drug during the treatment period.
Adverse events (AEs) and serious adverse events (SAEs) were collected from first dosing. Death routine laboratory assessments were assessed up to last follow-up visit or until the event had resolved to baseline grade or better, or the event was assessed stable by the investigator, or the participant was lost to follow-up or withdrew consent.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 Participants
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Number of Participants With Adverse Events or Serious Adverse Events, or Who Died
Deaths
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events or Serious Adverse Events, or Who Died
AEs
|
12 participants
|
79 participants
|
73 participants
|
|
Number of Participants With Adverse Events or Serious Adverse Events, or Who Died
SAEs
|
0 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. Cmax is the maximum (peak) observed plasma concentration of cipargamin after dose administration. Cmax was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=55 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Observed Maximum Plasma Concentration (Cmax) of IV Cipargamin
Dose 1 n=18,55
|
1350 ng/mL
Interval 1150.0 to 1570.0
|
3230 ng/mL
Interval 2870.0 to 3630.0
|
—
|
|
Observed Maximum Plasma Concentration (Cmax) of IV Cipargamin
Dose 2 n-20,55
|
1390 ng/mL
Interval 1150.0 to 1690.0
|
3420 ng/mL
Interval 3020.0 to 3880.0
|
—
|
|
Observed Maximum Plasma Concentration (Cmax) of IV Cipargamin
Dose 3 n=3,1
|
1160 ng/mL
Interval 553.0 to 2430.0
|
2720 ng/mL
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics. Time to reach maximum observed plasma concentration of cipargamin after dose administration.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=20 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=55 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of IV Cipargamin
Dose 1 n=18,55
|
0.099 hours
Interval 0.073 to 0.135
|
0.106 hours
Interval 0.089 to 0.125
|
—
|
|
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of IV Cipargamin
Dose 2 n=20,55
|
0.221 hours
Interval 0.133 to 0.366
|
0.158 hours
Interval 0.116 to 0.216
|
—
|
|
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of IV Cipargamin
Dose 3 n=3,1
|
0.141 hours
Interval 0.007 to 2.79
|
0.05 hours
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. AUClast was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=19 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=55 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of IV Cipargamin
Dose 2 n=19,55
|
19100 h*ng/mL
Interval 16100.0 to 22800.0
|
38700 h*ng/mL
Interval 34700.0 to 43100.0
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of IV Cipargamin
Dose 3 n=3,1
|
18600 h*ng/mL
Interval 6330.0 to 54400.0
|
40400 h*ng/mL
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
|
Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of IV Cipargamin
Dose 1 n=18,55
|
8150 h*ng/mL
Interval 6930.0 to 9580.0
|
18800 h*ng/mL
Interval 16900.0 to 21000.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. AUC(0-inf) post last dose was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=15 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=53 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of IV Cipargamin
Dose 2 n=15,53
|
21300 h*ng/mL
Interval 18000.0 to 25200.0
|
40000 h*ng/mL
Interval 36000.0 to 44500.0
|
—
|
|
Area Under the Concentration Time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of IV Cipargamin
Dose 3 n=3,1
|
18800 h*ng/mL
Interval 6360.0 to 55500.0
|
40400 h*ng/mL
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. AUC(0-24h) was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=19 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=55 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From the Time 0 to 24 Hours (AUC0-24hours) of IV Cipargamin
Dose 1 n=18,55
|
8170 h*ng/mL
Interval 6950.0 to 9590.0
|
19200 h*ng/mL
Interval 17300.0 to 21300.0
|
—
|
|
Area Under the Plasma Concentration-time Curve From the Time 0 to 24 Hours (AUC0-24hours) of IV Cipargamin
Dose 2 n=19,54
|
11900 h*ng/mL
Interval 10700.0 to 13200.0
|
28500 h*ng/mL
Interval 25900.0 to 31400.0
|
—
|
|
Area Under the Plasma Concentration-time Curve From the Time 0 to 24 Hours (AUC0-24hours) of IV Cipargamin
Dose 3 n=3,1
|
10100 h*ng/mL
Interval 5800.0 to 17600.0
|
26500 h*ng/mL
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. The half-life post last dose was summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=15 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=53 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Terminal Elimination Half Life (T1/2) of IV Cipargamin
Dose 2 n=15,53
|
18 hours
Interval 15.7 to 20.7
|
11.6 hours
Interval 10.6 to 12.6
|
—
|
|
Terminal Elimination Half Life (T1/2) of IV Cipargamin
Dose 3 n=3,1
|
16.2 hours
Interval 8.35 to 31.4
|
10.8 hours
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. CL post last dose was summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=15 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=53 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Total Systemic Clearance for Intravenous Administration (CL) of IV Cipargamin
Dose 2 n=15,53
|
0.939 L/h
Interval 0.793 to 1.11
|
0.66 L/h
Interval 0.576 to 0.755
|
—
|
|
Total Systemic Clearance for Intravenous Administration (CL) of IV Cipargamin
Dose 3 n=3,1
|
1.06 L/h
Interval 0.36 to 3.15
|
0.99 L/h
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 - Day 8Population: The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data.
Blood samples were collected for pharmacokinetics characterization. Vz post last dose was listed and summarized using descriptive statistics.
Outcome measures
| Measure |
IV Cipargamin 20 mg
n=15 Participants
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=53 Participants
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
|---|---|---|---|
|
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of IV Cipargamin
Dose 2 n=15,53
|
24.5 liters
Interval 21.2 to 28.2
|
11 liters
Interval 9.34 to 13.0
|
—
|
|
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of IV Cipargamin
Dose 3 n=3,1
|
24.9 liters
Interval 15.0 to 41.1
|
15.5 liters
The lower and upper limits of 90% CI were not calculable due to the single data point.
|
—
|
Adverse Events
IV Cipargamin 20 mg
IV Cipargamin 40 mg
IV Artesunate
Total
Serious adverse events
| Measure |
IV Cipargamin 20 mg
n=20 participants at risk
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 participants at risk
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 participants at risk
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
Total
n=251 participants at risk
Total
|
|---|---|---|---|---|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.85%
1/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.40%
1/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.88%
1/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.40%
1/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.88%
1/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
1.7%
2/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
1.2%
3/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.85%
1/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.40%
1/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.88%
1/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.40%
1/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Infections and infestations
Malaria
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
1.8%
2/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.80%
2/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.00%
0/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.85%
1/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.40%
1/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
Other adverse events
| Measure |
IV Cipargamin 20 mg
n=20 participants at risk
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Cipargamin 40 mg
n=114 participants at risk
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
|
IV Artesunate
n=117 participants at risk
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
|
Total
n=251 participants at risk
Total
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
5/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
35.1%
40/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
29.9%
35/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
31.9%
80/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Infections and infestations
Malaria
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
14.0%
16/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
10.3%
12/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
11.2%
28/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Infections and infestations
Rhinitis
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
6.1%
7/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
3.4%
4/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
4.8%
12/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
6.1%
7/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
4.3%
5/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
4.8%
12/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
0.88%
1/114 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
1.7%
2/117 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
2.0%
5/251 • Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER