Trial Outcomes & Findings for Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2) (NCT NCT05974267)
NCT ID: NCT05974267
Last Updated: 2026-02-06
Results Overview
The time (in days) to first recorded parasitemia (parasite count \>0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
From treatment Day 1 up to End of observation period Day 64 (Week 10)
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Cohort 1: M5717 (60 mg) + Pyronaridine
Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms \[kg\]) or pyronaridine 540 mg (for participants ≥ 45 to less than (\<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
48
|
48
|
|
Overall Study
COMPLETED
|
29
|
27
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
20
|
20
|
16
|
16
|
Reasons for withdrawal
| Measure |
Cohort 1: M5717 (60 mg) + Pyronaridine
Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms \[kg\]) or pyronaridine 540 mg (for participants ≥ 45 to less than (\<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
19
|
19
|
15
|
15
|
|
Overall Study
OTHER: THE PARENT OF THE PARTICIPANT WHO IS A MINOR, WITHDREW THE PARTICIPANT FROM THE TRIAL
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Baseline characteristics by cohort
| Measure |
Cohort 1: M5717 (60 mg) + Pyronaridine
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms \[kg\]) or pyronaridine 540 mg (for participants ≥ 45 to less than (\<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
23 Years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
24 Years
STANDARD_DEVIATION 8.9 • n=1581 Participants
|
25 Years
STANDARD_DEVIATION 9.2 • n=4626 Participants
|
25 Years
STANDARD_DEVIATION 11.2 • n=72 Participants
|
25 Years
STANDARD_DEVIATION 9.5 • n=11 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=41 Participants
|
16 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
19 Participants
n=72 Participants
|
75 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
28 Participants
n=4626 Participants
|
29 Participants
n=72 Participants
|
117 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Hispanic or Latino
|
1 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
6 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Not Hispanic or Latino
|
48 Participants
n=41 Participants
|
45 Participants
n=1581 Participants
|
44 Participants
n=4626 Participants
|
48 Participants
n=72 Participants
|
185 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Race-Black or African American
|
49 Participants
n=41 Participants
|
47 Participants
n=1581 Participants
|
48 Participants
n=4626 Participants
|
48 Participants
n=72 Participants
|
192 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: From treatment Day 1 up to End of observation period Day 64 (Week 10)Population: The Full Analysis Set included all randomized participants.
The time (in days) to first recorded parasitemia (parasite count \>0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Time to Parasitemia Since Negative Blood Smear After Treatment
|
62.0 days
Interval 49.0 to 100.0
|
60.0 days
Interval 47.0 to 100.0
|
NA days
Interval 61.0 to 100.0
Median not estimable due to an insufficient number of participants with events (parasitemia).
|
NA days
Interval 59.0 to 100.0
Median not estimable due to an insufficient number of participants with events (parasitemia).
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 up to End of observation period Day 64 (Week 10)Population: The Full Analysis Set included all randomized participants.
Percentage of participants with a positive blood smear (parasitemia) was reported. Parasitemia is the presence of parasites in blood (parasite count \>0).
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Parasitemia (Positive Blood Smear)
|
53.1 percentage of participants
|
51.1 percentage of participants
|
35.4 percentage of participants
|
37.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 up to End of observation period Day 64 (Week 10)Population: The Full Analysis Set included all randomized participants.
Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques) was reported.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Parasitemia (Due to New Infections)
|
40.8 percentage of participants
|
36.2 percentage of participants
|
29.2 percentage of participants
|
31.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From treatment Day 1 up to End of observation period Day 64 (Week 10)Population: The Full Analysis Set included all randomized participants.
Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques) was reported.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants With PCR-adjusted Parasitemia (Due to Recrudescence)
|
4.1 percentage of participants
|
12.8 percentage of participants
|
4.2 percentage of participants
|
4.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeksPopulation: The Full Analysis Set included all randomized participants. Here overall number of participants analyzed signifies participants who had a baseline parasite density of \>0.
Parasite clearance time defined as time from dosing to the first negative (no parasites) blood film (microscopy). Median parasite clearance time was estimated by Kaplan-Meier method
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=46 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=47 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Parasite Clearance Time
|
24.1 hours
Interval 6.2 to 39.0
|
24.2 hours
Interval 12.2 to 39.8
|
24.0 hours
Interval 12.1 to 48.2
|
25.0 hours
Interval 24.1 to 48.0
|
—
|
SECONDARY outcome
Timeframe: Up to End of Study (approximately 12 Weeks)Population: Safety Analysis Set includes all participants who were administered any dose of any study intervention.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=49 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs
Participants with TEAEs
|
31 Participants
|
27 Participants
|
31 Participants
|
28 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs
Participants with Serious TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs
Participants with Treatment-related TEAEs
|
6 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717 and Pyronaridine
|
613.64 hour*nanogram per milliliter(hour*ng/mL)
Geometric Coefficient of Variation 1.1
|
2292.02 hour*nanogram per milliliter(hour*ng/mL)
Geometric Coefficient of Variation 0.5
|
9988.92 hour*nanogram per milliliter(hour*ng/mL)
Geometric Coefficient of Variation 0.4
|
5985.14 hour*nanogram per milliliter(hour*ng/mL)
Geometric Coefficient of Variation 0.5
|
6418.17 hour*nanogram per milliliter(hour*ng/mL)
Geometric Coefficient of Variation 0.3
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717 and Pyronaridine
|
205.87 h*ng/mL
Geometric Coefficient of Variation 0.4
|
743.74 h*ng/mL
Geometric Coefficient of Variation 0.5
|
3303.65 h*ng/mL
Geometric Coefficient of Variation 0.4
|
1594.05 h*ng/mL
Geometric Coefficient of Variation 0.6
|
1742.89 h*ng/mL
Geometric Coefficient of Variation 0.4
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717 and Pyronaridine
|
455.40 h*ng/mL
Geometric Coefficient of Variation 0.5
|
2040.41 h*ng/mL
Geometric Coefficient of Variation 0.5
|
9635.73 h*ng/mL
Geometric Coefficient of Variation 0.4
|
5393.62 h*ng/mL
Geometric Coefficient of Variation 0.6
|
5793.71 h*ng/mL
Geometric Coefficient of Variation 0.4
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Apparent Total Body Clearance From Blood (CL/f) of M5717 and Pyronaridine
|
97.77 Liter per Hours (L/h)
Geometric Coefficient of Variation 1.1
|
87.25 Liter per Hours (L/h)
Geometric Coefficient of Variation 0.5
|
66.07 Liter per Hours (L/h)
Geometric Coefficient of Variation 0.4
|
90.22 Liter per Hours (L/h)
Geometric Coefficient of Variation 0.5
|
112.18 Liter per Hours (L/h)
Geometric Coefficient of Variation 0.3
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
Cmax was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Maximum Observed Blood Concentration (Cmax) of M5717 and Pyronaridine
|
15.19 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.6
|
59.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.6
|
254.50 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.5
|
157.81 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.6
|
166.46 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 0.4
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of M5717 and Pyronaridine
|
46.013 hour
Geometric Coefficient of Variation 1.3
|
64.663 hour
Geometric Coefficient of Variation 0.4
|
90.234 hour
Geometric Coefficient of Variation 0.5
|
264.15 hour
Geometric Coefficient of Variation 0.4
|
246.94 hour
Geometric Coefficient of Variation 0.6
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Time to Reach the Maximum Blood Concentration (Tmax) of M5717 and Pyronaridine
|
4.067 hour
Interval 1.05 to 141.07
|
4.00 hour
Interval 1.0 to 12.1
|
4.00 hour
Interval 1.08 to 175.57
|
2.10 hour
Interval 1.0 to 7.42
|
2.08 hour
Interval 1.0 to 12.08
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2Population: Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, \& provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure.
The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf) multiply Lambda(z).
Outcome measures
| Measure |
Cohort 1: M5717 60 mg
n=45 Participants
Participants received a single oral dose of M5717 60 milligrams (mg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=44 Participants
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=43 Participants
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=99 Participants
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
Cohort 1, 2 and 3: Pyronaridine 720 mg
n=33 Participants
Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717 and Pyronaridine
|
6490.76 liter
Geometric Coefficient of Variation 0.5
|
8140.36 liter
Geometric Coefficient of Variation 0.4
|
8601.43 liter
Geometric Coefficient of Variation 0.5
|
34383.091 liter
Geometric Coefficient of Variation 0.5
|
39966.70 liter
Geometric Coefficient of Variation 0.7
|
Adverse Events
Cohort 1: M5717 (60 mg) + Pyronaridine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 2: M5717 (200 mg) + Pyronaridine
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Cohort 3: M5717 (660 mg)+ Pyronaridine
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 4: Atovaquone-proguanil
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: M5717 (60 mg) + Pyronaridine
n=49 participants at risk
Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms \[kg\]) or pyronaridine 540 mg (for participants ≥ 45 to less than (\<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 participants at risk
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 participants at risk
participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 participants at risk
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
Other adverse events
| Measure |
Cohort 1: M5717 (60 mg) + Pyronaridine
n=49 participants at risk
Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms \[kg\]) or pyronaridine 540 mg (for participants ≥ 45 to less than (\<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 2: M5717 (200 mg) + Pyronaridine
n=47 participants at risk
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition.
|
Cohort 3: M5717 (660 mg)+ Pyronaridine
n=48 participants at risk
participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and \< 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
|
Cohort 4: Atovaquone-proguanil
n=48 participants at risk
Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen.
|
|---|---|---|---|---|
|
Infections and infestations
Malaria
|
28.6%
14/49 • Number of events 14 • End of Study (approximately 12 Weeks)
|
25.5%
12/47 • Number of events 12 • End of Study (approximately 12 Weeks)
|
20.8%
10/48 • Number of events 10 • End of Study (approximately 12 Weeks)
|
14.6%
7/48 • Number of events 7 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
4/49 • Number of events 4 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Plasmodium ovale infection
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Rhinitis
|
4.1%
2/49 • Number of events 2 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Schistosomiasis
|
6.1%
3/49 • Number of events 3 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
3/49 • Number of events 3 • End of Study (approximately 12 Weeks)
|
8.5%
4/47 • Number of events 4 • End of Study (approximately 12 Weeks)
|
8.3%
4/48 • Number of events 4 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Urinary tract infection
|
4.1%
2/49 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
6.2%
3/48 • Number of events 3 • End of Study (approximately 12 Weeks)
|
6.2%
3/48 • Number of events 3 • End of Study (approximately 12 Weeks)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
3/49 • Number of events 3 • End of Study (approximately 12 Weeks)
|
6.4%
3/47 • Number of events 3 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
10.4%
5/48 • Number of events 5 • End of Study (approximately 12 Weeks)
|
|
Investigations
Blood alkaline phosphatase increased
|
10.2%
5/49 • Number of events 5 • End of Study (approximately 12 Weeks)
|
12.8%
6/47 • Number of events 6 • End of Study (approximately 12 Weeks)
|
6.2%
3/48 • Number of events 3 • End of Study (approximately 12 Weeks)
|
14.6%
7/48 • Number of events 7 • End of Study (approximately 12 Weeks)
|
|
Investigations
Blood bilirubin increased
|
14.3%
7/49 • Number of events 7 • End of Study (approximately 12 Weeks)
|
8.5%
4/47 • Number of events 4 • End of Study (approximately 12 Weeks)
|
8.3%
4/48 • Number of events 4 • End of Study (approximately 12 Weeks)
|
8.3%
4/48 • Number of events 4 • End of Study (approximately 12 Weeks)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Protein total decreased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Investigations
Red blood cell count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Respiratory rate increased
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
White blood cell count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
6.1%
3/49 • Number of events 3 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
6.2%
3/48 • Number of events 3 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
6.2%
3/48 • Number of events 3 • End of Study (approximately 12 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Eosinophil count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Heart rate decreased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Investigations
Monocyte count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Investigations
pH urine increased
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
General disorders
Asthenia
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
General disorders
Chills
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
General disorders
Fatigue
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
General disorders
Malaise
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
General disorders
Pain
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
General disorders
Vessel puncture site haematoma
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Immune system disorders
Allergy to arthropod sting
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Body tinea
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Bronchitis
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Furuncle
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.2%
2/48 • Number of events 2 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
2.1%
1/47 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
4.3%
2/47 • Number of events 2 • End of Study (approximately 12 Weeks)
|
10.4%
5/48 • Number of events 5 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Nervous system disorders
Headache
|
14.3%
7/49 • Number of events 7 • End of Study (approximately 12 Weeks)
|
6.4%
3/47 • Number of events 3 • End of Study (approximately 12 Weeks)
|
12.5%
6/48 • Number of events 6 • End of Study (approximately 12 Weeks)
|
18.8%
9/48 • Number of events 9 • End of Study (approximately 12 Weeks)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/49 • End of Study (approximately 12 Weeks)
|
0.00%
0/47 • End of Study (approximately 12 Weeks)
|
0.00%
0/48 • End of Study (approximately 12 Weeks)
|
2.1%
1/48 • Number of events 1 • End of Study (approximately 12 Weeks)
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place