Trial Outcomes & Findings for Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients (NCT NCT00403260)
NCT ID: NCT00403260
Last Updated: 2021-11-02
Results Overview
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1271 participants
Primary outcome timeframe
Day 28
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Pyronaridine - Artesunate
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Overall Study
STARTED
|
848
|
423
|
|
Overall Study
COMPLETED
|
723
|
357
|
|
Overall Study
NOT COMPLETED
|
125
|
66
|
Reasons for withdrawal
| Measure |
Pyronaridine - Artesunate
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
49
|
25
|
|
Overall Study
Re-appearance of P. falciparum
|
34
|
25
|
|
Overall Study
P. vivax infection
|
26
|
4
|
|
Overall Study
Mixed infection with P. vivax
|
2
|
0
|
|
Overall Study
Mixed infection with P. falciparum
|
1
|
0
|
|
Overall Study
P. vivax infection at screening
|
1
|
0
|
|
Overall Study
P. ovale infection
|
1
|
0
|
|
Overall Study
Gametocyte re-appearance
|
1
|
1
|
|
Overall Study
Withdrawn from study accidentally
|
0
|
1
|
Baseline Characteristics
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Baseline characteristics by cohort
| Measure |
Pyronaridine - Artesunate
n=848 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=423 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
Total
n=1271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
n=93 Participants
|
23.0 years
n=4 Participants
|
23.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
307 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
634 Participants
n=93 Participants
|
330 Participants
n=4 Participants
|
964 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
689 Participants
n=93 Participants
|
344 Participants
n=4 Participants
|
1033 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
159 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Vietnam
|
108 participants
n=93 Participants
|
55 participants
n=4 Participants
|
163 participants
n=27 Participants
|
|
Region of Enrollment
Burkina Faso
|
83 participants
n=93 Participants
|
39 participants
n=4 Participants
|
122 participants
n=27 Participants
|
|
Region of Enrollment
Cambodia
|
140 participants
n=93 Participants
|
71 participants
n=4 Participants
|
211 participants
n=27 Participants
|
|
Region of Enrollment
Tanzania
|
25 participants
n=93 Participants
|
13 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Region of Enrollment
Côte D'Ivoire
|
51 participants
n=93 Participants
|
27 participants
n=4 Participants
|
78 participants
n=27 Participants
|
|
Region of Enrollment
Thailand
|
402 participants
n=93 Participants
|
198 participants
n=4 Participants
|
600 participants
n=27 Participants
|
|
Region of Enrollment
India
|
39 participants
n=93 Participants
|
20 participants
n=4 Participants
|
59 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure.
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=749 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=367 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28
|
99.2 percentage of subjects
Interval 98.3 to 99.7
|
98.1 percentage of subjects
Interval 96.1 to 99.2
|
SECONDARY outcome
Timeframe: Day 14Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=749 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=367 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
PCR-corrected ACPR on Day 14
|
99.9 percentage of subjects
Interval 99.3 to 100.0
|
99.5 percentage of subjects
Interval 98.0 to 99.9
|
SECONDARY outcome
Timeframe: Days 14 and 28Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Percentage of subjects with adequate clinical and parasitological response (ACPR) on Days 14 and 28, without correction by PCR, defined as absence of parasitaemia on Days 14 and 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=749 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=367 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Crude ACPR on Days 14 and 28
Cure rate (%) on Day 14
|
99.9 percentage of subjects
Interval 99.3 to 100.0
|
99.5 percentage of subjects
Interval 98.0 to 99.9
|
|
Crude ACPR on Days 14 and 28
Cure rate (%) on Day 28
|
98.7 percentage of subjects
Interval 97.6 to 99.4
|
96.7 percentage of subjects
Interval 94.4 to 98.3
|
SECONDARY outcome
Timeframe: Thick blood films were examined every 8 hours until ≥72 hours or until 2 consecutive negative readings occurred 7 to 25 hours apart, and on Days 3, 7, 14, 21, 28, 35, and 42 (or any other day if the subject returned).Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Parasite clearance time was defined as the time from first dosing to time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=749 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=367 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Parasite Clearance Time
|
31.7 hours
Interval 31.4 to 31.8
|
32.0 hours
Interval 31.8 to 36.8
|
SECONDARY outcome
Timeframe: Every 8 hours over ≥72 hours following first study drug administration or temperature normalisation for ≥2 readings between 7 and 25 hours apart, then at each visit.Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Fever clearance time was defined as the time from first dosing to first normal reading of temperature (\<37.5°C taken axillary or tympanic; \<38°C taken oral or rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart.
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=627 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=313 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Fever Clearance Time
|
15.9 hours
Interval 15.7 to 16.0
|
16.0 hours
Interval 15.7 to 16.0
|
SECONDARY outcome
Timeframe: Days 1, 2 and 3Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Parasite clearance time was defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=749 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=367 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Parasite Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 1 (24h after first dose)
|
38.5 percentage of subjects
Interval 35.1 to 42.0
|
31.6 percentage of subjects
Interval 27.1 to 36.6
|
|
Parasite Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 2 (48h after first dose)
|
83.8 percentage of subjects
Interval 81.1 to 86.4
|
79.8 percentage of subjects
Interval 75.6 to 83.8
|
|
Parasite Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 3 (48h after first dose)
|
91.5 percentage of subjects
Interval 89.3 to 93.3
|
90.5 percentage of subjects
Interval 87.2 to 93.2
|
SECONDARY outcome
Timeframe: Days 1, 2 and 3Population: Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.
Fever clearance time was defined as the time for at least 2 consecutive normal body temperature measurements (\<37.5°C axillary/tympanic or \<38.0°C oral/rectal) to be obtained within an interval of 7 to 25 hours post-dosing.
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=627 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=313 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Fever Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 1 (24h after first dose)
|
78.5 percentage of subjects
Interval 75.2 to 81.6
|
78.9 percentage of subjects
Interval 74.2 to 83.2
|
|
Fever Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 2 (48h after first dose)
|
95.9 percentage of subjects
Interval 94.1 to 97.2
|
96.2 percentage of subjects
Interval 93.6 to 99.9
|
|
Fever Clearance at Day 1, 2 and 3
Clearance rate (%) at Day 3 (72h after first dose)
|
99.2 percentage of subjects
Interval 98.2 to 99.7
|
98.4 percentage of subjects
Interval 96.5 to 99.4
|
SECONDARY outcome
Timeframe: Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlierPopulation: The safety population consisted of all randomised subjects who received any amount of study medication; subjects were analysed as treated.
Cases and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities
Outcome measures
| Measure |
Pyronaridine - Artesunate
n=848 Participants
Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.
|
Mefloquine Plus Artesunate
n=423 Participants
Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.
|
|---|---|---|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 AE
|
389 Participants
|
190 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 treatment-related AE
|
153 Participants
|
94 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 SAE
|
6 Participants
|
3 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 treatment-related SAE
|
0 Participants
|
2 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 severe or life threatenining AE
|
24 Participants
|
23 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 AE leading to death
|
0 Participants
|
0 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj with ≥1 AE leading to drug discontinuation
|
5 Participants
|
4 Participants
|
|
Adverse Events and Clinically Significant Laboratory Results
Nr subj. with ≥1 AE leading to study withdrawal
|
5 Participants
|
4 Participants
|
Adverse Events
Pyronaridine - Artesunate
Serious events: 6 serious events
Other events: 389 other events
Deaths: 0 deaths
Mefloquine Plus Artesunate
Serious events: 3 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pyronaridine - Artesunate
n=848 participants at risk
Pyronaridine artesunate (180:60mg)
Pyronaridine artesunate: once a day for 3 days
|
Mefloquine Plus Artesunate
n=423 participants at risk
Mefloquine (250mg) plus artesunate (100mg)
Mefloquine plus artesunate: once a day for 3 days
|
|---|---|---|
|
Infections and infestations
Cholera
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Wound infection
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Pneumonia
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Psychiatric disorders
Depression
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/848 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.24%
1/423 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/848 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.24%
1/423 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Cerebral malaria
|
0.00%
0/848 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.24%
1/423 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
Other adverse events
| Measure |
Pyronaridine - Artesunate
n=848 participants at risk
Pyronaridine artesunate (180:60mg)
Pyronaridine artesunate: once a day for 3 days
|
Mefloquine Plus Artesunate
n=423 participants at risk
Mefloquine (250mg) plus artesunate (100mg)
Mefloquine plus artesunate: once a day for 3 days
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
53/848 • Number of events 60 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
4.5%
19/423 • Number of events 20 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Nervous system disorders
Dizziness
|
3.1%
26/848 • Number of events 26 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
6.6%
28/423 • Number of events 29 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Nervous system disorders
Headache
|
11.9%
101/848 • Number of events 120 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
10.4%
44/423 • Number of events 48 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.6%
39/848 • Number of events 41 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
3.1%
13/423 • Number of events 13 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
31/848 • Number of events 31 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
4.0%
17/423 • Number of events 17 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Blood and lymphatic system disorders
Basophilia
|
0.94%
8/848 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
2.1%
9/423 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.4%
20/848 • Number of events 20 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.2%
5/423 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
3/848 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.7%
7/423 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
14/848 • Number of events 14 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.7%
7/423 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
10/848 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
2.1%
9/423 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
9/848 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.9%
8/423 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
18/848 • Number of events 18 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
2.1%
9/423 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
General disorders
Fatigue
|
1.9%
16/848 • Number of events 18 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.4%
6/423 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
General disorders
Pyrexia
|
1.4%
12/848 • Number of events 12 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.95%
4/423 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Bronchitis
|
1.8%
15/848 • Number of events 15 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.4%
6/423 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
21/848 • Number of events 21 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
2.6%
11/423 • Number of events 11 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
21/848 • Number of events 21 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.00%
0/423 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
19/848 • Number of events 19 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.24%
1/423 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Blood creatinine phosphokinase increased
|
1.4%
12/848 • Number of events 12 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.95%
4/423 • Number of events 4 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.12%
1/848 • Number of events 1 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.2%
5/423 • Number of events 5 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Eosinophil count increased
|
1.1%
9/848 • Number of events 9 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.4%
6/423 • Number of events 6 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Haemoglobin decreased
|
2.5%
21/848 • Number of events 21 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.7%
7/423 • Number of events 7 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Platelet count increased
|
1.2%
10/848 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.71%
3/423 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Investigations
Transaminases increased
|
2.1%
18/848 • Number of events 18 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
0.71%
3/423 • Number of events 3 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Psychiatric disorders
Insomnia
|
1.5%
13/848 • Number of events 13 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
1.9%
8/423 • Number of events 8 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
30/848 • Number of events 33 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
2.4%
10/423 • Number of events 10 • Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place