Trial Outcomes & Findings for Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers (NCT NCT01868438)
NCT ID: NCT01868438
Last Updated: 2023-12-18
Results Overview
Pharmacokinetic blood sampling for first or second intervention dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
First intervention: Day 1 pre-dose to Day 43 visit (D1, 2, 3, 4, 6, 8, 15, 22, 29, 36, 43) ; second intervention: Day 61 pre-dose to Day 103 visit (D61, 62, 63, 64, 66, 68, 75, 82, 89, 96, 103)
Results posted on
2023-12-18
Participant Flow
30 Volunteers were recruited to Sequence 1 and 30 to Sequence 2 (60 total). Since this is a crossover study from tablets to granules (Sequence 1) or vice versa (Sequence 2), overall there is a planned 60 volunteers taking tablets and 60 volunteers taking granules.
Participant milestones
| Measure |
Pyronaridine-artesunate Tablets First, Then Pyronaridine-artesunate Granules
Participants first received a single administration of 3 180:60 mg pyronaridine-artesunate tablets. After a washout period of 60-days, they then received a single administration of 9 sachets of 60:20 mg pyronaridine-artesunate granules. Total doses for both formulations were 540mg pyronaridine + 180mg artesunate.
|
Pyronaridine-artesunate Granules First, Then Pyronaridine-artesunate Tablets
Participants first received a single administration of 9 sachets of 60:20 mg pyronaridine-artesunate granules. of. After a washout period of 60-days, they then received a single administration of 3 180:60 mg pyronaridine-artesunate tablets. Total doses for both formulations were 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
30
|
|
First Intervention
COMPLETED
|
23
|
25
|
|
First Intervention
NOT COMPLETED
|
7
|
5
|
|
Second Intervention
STARTED
|
23
|
25
|
|
Second Intervention
COMPLETED
|
20
|
22
|
|
Second Intervention
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Pyronaridine-artesunate Tablets First, Then Pyronaridine-artesunate Granules
Participants first received a single administration of 3 180:60 mg pyronaridine-artesunate tablets. After a washout period of 60-days, they then received a single administration of 9 sachets of 60:20 mg pyronaridine-artesunate granules. Total doses for both formulations were 540mg pyronaridine + 180mg artesunate.
|
Pyronaridine-artesunate Granules First, Then Pyronaridine-artesunate Tablets
Participants first received a single administration of 9 sachets of 60:20 mg pyronaridine-artesunate granules. of. After a washout period of 60-days, they then received a single administration of 3 180:60 mg pyronaridine-artesunate tablets. Total doses for both formulations were 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
5
|
1
|
|
First Intervention
Lost to Follow-up
|
2
|
3
|
|
First Intervention
Meeting the non-redosing criteria
|
0
|
1
|
|
Second Intervention
Adverse Event
|
3
|
3
|
Baseline Characteristics
Relative Bioavailability of Pyronaridine-artesunate in Tablet and Granule Formulations in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Volunteers Enrolled
n=60 Participants
Includes both tablets and granules groups
|
|---|---|
|
Age, Customized
20-24 years
|
33 Participants
n=5 Participants
|
|
Age, Customized
25-29 years
|
18 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
40-45 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
60 Participants
n=5 Participants
|
|
BMI
|
22.78 kg/m^2
STANDARD_DEVIATION 1.60 • n=5 Participants
|
PRIMARY outcome
Timeframe: First intervention: Day 1 pre-dose to Day 43 visit (D1, 2, 3, 4, 6, 8, 15, 22, 29, 36, 43) ; second intervention: Day 61 pre-dose to Day 103 visit (D61, 62, 63, 64, 66, 68, 75, 82, 89, 96, 103)Population: Number analyzed includes only subjects completing both periods with estimable parameters.
Pharmacokinetic blood sampling for first or second intervention dose
Outcome measures
| Measure |
Total Receiving Pyronaridine-artesunate Tablets
n=42 Participants
Sequence 1: period 1 single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 2: period 2 cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
|
Total Receiving Pyronaridine-artesunate Granules
n=42 Participants
Sequence 2: period 1 single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 1: period 2 cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Hour 0 to the Last Sampling Point (AUC 0-t) for Pyronaridine and Dihydroartemisinin (DHA)
AUC 0-t pyronaridine
|
11640 ng*h/ml
Standard Deviation 4344
|
11324 ng*h/ml
Standard Deviation 3927
|
|
Area Under the Concentration-time Curve From Hour 0 to the Last Sampling Point (AUC 0-t) for Pyronaridine and Dihydroartemisinin (DHA)
AUC 0-t DHA
|
1119 ng*h/ml
Standard Deviation 364
|
829 ng*h/ml
Standard Deviation 328
|
SECONDARY outcome
Timeframe: First intervention: Day 1 pre-dose to Day 43 visit (D1, 2, 3, 4, 6, 8, 15, 22, 29, 36, 43) ; second intervention: Day 61 pre-dose to Day 103 visit (D61, 62, 63, 64, 66, 68, 75, 82, 89, 96, 103)Population: Number analyzed includes only subjects completing both periods with estimable parameters.
Pharmacokinetic blood sampling for first or second intervention dose
Outcome measures
| Measure |
Total Receiving Pyronaridine-artesunate Tablets
n=42 Participants
Sequence 1: period 1 single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 2: period 2 cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
|
Total Receiving Pyronaridine-artesunate Granules
n=42 Participants
Sequence 2: period 1 single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 1: period 2 cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Tmax pyronaridine
|
2.1 hours
Standard Deviation 2
|
1.7 hours
Standard Deviation 1.6
|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Half-life pyronaridine
|
639 hours
Standard Deviation 262.2
|
591.8 hours
Standard Deviation 372.9
|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Tmax artesunate
|
0.98 hours
Standard Deviation 0.544
|
1.52 hours
Standard Deviation 0.921
|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Half-life artesunate
|
0.33 hours
Standard Deviation 0.0852
|
0.71 hours
Standard Deviation 0.112
|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Tmax DHA
|
1.46 hours
Standard Deviation 0.69
|
2.26 hours
Standard Deviation 0.871
|
|
Tmax and Terminal Half Life for Pyronaridine, Artesunate and DHA
Half-life DHA
|
1.50 hours
Standard Deviation 0.713
|
1.43 hours
Standard Deviation 0.718
|
SECONDARY outcome
Timeframe: End of study (Day 103)Outcome measures
| Measure |
Total Receiving Pyronaridine-artesunate Tablets
n=55 Participants
Sequence 1: period 1 single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 2: period 2 cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
|
Total Receiving Pyronaridine-artesunate Granules
n=53 Participants
Sequence 2: period 1 single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 1: period 2 cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
Safety Evaluation - Summary of Adverse Events
Adverse event before treatment
|
2 Participants
|
0 Participants
|
|
Safety Evaluation - Summary of Adverse Events
Treatment-emergent adverse event
|
22 Participants
|
23 Participants
|
|
Safety Evaluation - Summary of Adverse Events
Treatment-related adverse event
|
14 Participants
|
14 Participants
|
|
Safety Evaluation - Summary of Adverse Events
Serious adverse event
|
0 Participants
|
0 Participants
|
|
Safety Evaluation - Summary of Adverse Events
Serious adverse drug reaction
|
0 Participants
|
0 Participants
|
|
Safety Evaluation - Summary of Adverse Events
Adverse event leading to discontinuation
|
3 Participants
|
3 Participants
|
Adverse Events
Total Receiving Pyronaridine-artesunate Tablets
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Total Receiving Pyronaridine-artesunate Granules
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Total Receiving Pyronaridine-artesunate Tablets
n=55 participants at risk
Sequence 1: period 1 single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 2: period 2 cross-over to single administration of pyronaridine-artesunate tablets: total dose 540mg pyronaridine + 180mg artesunate.
|
Total Receiving Pyronaridine-artesunate Granules
n=53 participants at risk
Sequence 2: period 1 single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
Sequence 1: period 2 cross-over to single administration of pyronaridine-artesunate granules: total dose 540mg pyronaridine + 180mg artesunate.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.3%
4/55 • Number of events 4 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
11.3%
6/53 • Number of events 6 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
2/55 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
11.3%
6/53 • Number of events 6 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
3/55 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
5.7%
3/53 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.6%
2/55 • Number of events 2 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
5.7%
3/53 • Number of events 4 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
2/55 • Number of events 2 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
9.4%
5/53 • Number of events 5 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Investigations
Neutrophil count decreased
|
5.5%
3/55 • Number of events 4 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
5.7%
3/53 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Investigations
Blood bilrubin increased
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
2/55 • Number of events 2 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorroea
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Nervous system disorders
Headache
|
7.3%
4/55 • Number of events 7 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.6%
2/55 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/55 • Number of events 3 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
General disorders
Pyrexia
|
3.6%
2/55 • Number of events 2 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
General disorders
Chills
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
General disorders
Fatigue
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
General disorders
Feeling hot
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Infections and infestations
Hordeolum
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Eye disorders
Xanthopsia
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
0.00%
0/53 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/55 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
1.9%
1/53 • Number of events 1 • 103 days (end of study). All adverse events (AEs) were to be monitored up to resolution or if at the end of the study until <Grade 1 according to the World Health Organization (WHO) toxicity scale. Any serious AE (SAE) was to be monitored up to resolution or until no new medical information was expected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place