Trial Outcomes & Findings for A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria (NCT NCT02563496)
NCT ID: NCT02563496
Last Updated: 2020-11-02
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic analysis of tafenoquine. Pharmacokinetic parameters were determined using standard non-compartmental methods. AUC(0-infinity) of tafenoquine was evaluated for participants aged \>=2 years to \<16 years (weighing \>=5 kg). Pharmacokinetic (PK) population consisted of all participants with at least one PK sample taken at Days 3, 15, 29 and 60, with accurate dosing and sample time histories.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Days 3, 15, 29 and 60 post dose
Results posted on
2020-11-02
Participant Flow
This was an open label, Phase 2, multicenter study to assess the pharmacokinetics, safety and efficacy of tafenoquine in participants with Plasmodium Vivax Malaria.
A total of 66 participants were screened, of which 6 participants failed screening. Hence, 60 participants were enrolled in this study. The cohort Tafenoquine 50mg was initiated, but study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort. Hence, no participants were enrolled in this cohort.
Participant milestones
| Measure |
Tafenoquine 50 mg
Participants with weight band of \>=5 to \<=10 kilogram (kg) were planned to receive 50 milligram (mg) tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 100 mg
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
14
|
5
|
22
|
19
|
|
Overall Study
COMPLETED
|
0
|
14
|
5
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
Baseline characteristics by cohort
| Measure |
Tafenoquine 50 mg
Participants with weight band of \>=5 to \<=10 kilogram (kg) were planned to receive 50 milligram (mg) tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
4.6 Years
STANDARD_DEVIATION 1.99 • n=7 Participants
|
4.8 Years
STANDARD_DEVIATION 2.05 • n=5 Participants
|
10.2 Years
STANDARD_DEVIATION 1.82 • n=4 Participants
|
12.8 Years
STANDARD_DEVIATION 1.62 • n=21 Participants
|
9.3 Years
STANDARD_DEVIATION 3.80 • n=8 Participants
|
|
Sex: Female, Male
Female
|
—
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
—
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
—
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian: South East Asian Heritage
|
—
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 3, 15, 29 and 60 post dosePopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tafenoquine. Pharmacokinetic parameters were determined using standard non-compartmental methods. AUC(0-infinity) of tafenoquine was evaluated for participants aged \>=2 years to \<16 years (weighing \>=5 kg). Pharmacokinetic (PK) population consisted of all participants with at least one PK sample taken at Days 3, 15, 29 and 60, with accurate dosing and sample time histories.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=4 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=18 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Area Under the Curve From Time 0 Extrapolated to Infinite Time (AUC[0-infinity]) of Tafenoquine by Weight Band in Participants Aged >=2 Years to <16 Years (Weighing >=5 kg)
|
85.1 Hours*microgram per milliliter
Interval 47.1 to 116.2
|
154.7 Hours*microgram per milliliter
Interval 107.4 to 247.1
|
111.4 Hours*microgram per milliliter
Interval 73.8 to 143.0
|
120.8 Hours*microgram per milliliter
Interval 36.1 to 181.2
|
SECONDARY outcome
Timeframe: Up to Day 120Population: Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Number of participants experiencing gastrointestinal adverse events including vomiting, abdominal pain, diarrhea, gastrointestinal disorder, epigastric discomfort and nausea were assessed. Number of participants with gastrointestinal adverse events for each treatment group have been presented. Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine).
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Gastrointestinal Adverse Events
Vomiting
|
2 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Gastrointestinal Adverse Events
Abdominal pain
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gastrointestinal Adverse Events
Diarrhea
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gastrointestinal Adverse Events
Gastrointestinal disorder
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gastrointestinal Adverse Events
Epigastric discomfort
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gastrointestinal Adverse Events
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Day 10Population: Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency is known to be a risk factor for hemolysis in participants treated with 8-aminoquinolines. Blood samples were collected for the evaluation of hemoglobin levels. Hemoglobin decrease of \>=30 percent (%) of \>30 grams per liter (g/L) from Baseline; or, an overall drop in hemoglobin below 60.0 g/L in the first 15 days of the study were considered as protocol defined serious adverse events (SAEs). Number of participants with hemoglobin decline from Baseline over first 10 days have been presented. Baseline was defined as the latest pre-tafenoquine dose assessment on Day 1.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days
<=20 g/L
|
14 Participants
|
5 Participants
|
21 Participants
|
19 Participants
|
|
Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days
>20 g/L to <=30 g/L
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days
>30 g/L or >=30%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 120Population: Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
Non-SAEs
|
10 Participants
|
4 Participants
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Day 8Population: Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Blood samples were collected for analysis of eosinophils, lymphocytes, platelets and reticulocytes. PCI ranges were \>1.5\*10\^9 (high) cells per liter (cells/L) for eosinophils, \<0.5\*10\^9 cells/L (low) or \>4\*10\^9 cells/L (high) for lymphocytes, \<50\*10\^9 cells/L (low) for platelet count and \>1\*upper limit of normal (ULN) 10\^12 cells/L (high) for reticulocyte count. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Baseline value is the latest pre-tafenoquine dose assessment on Day 1.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To within Range or No Change
|
12 Participants
|
4 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To High
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To within Range or No Change
|
9 Participants
|
3 Participants
|
20 Participants
|
16 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To High
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelet count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelet count: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelet count: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Reticulocyte count: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Reticulocyte count: To within Range or No Change
|
13 Participants
|
5 Participants
|
18 Participants
|
15 Participants
|
|
Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Reticulocyte count: To High
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Day 8Population: Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Blood samples were collected for analysis of clinical chemistry parameters. PCI ranges were \>3\*ULN international units per liter (IU/L) (alanine aminotransferase \[ALT\]), \>2.5\*ULN IU/L (alkaline phosphatase), \>3\*ULN IU/L (aspartate aminotransferase \[AST\]), \>1.5\*ULN micromoles/L (mcmol/L) (bilirubin), \>5\*ULN IU/L (creatine kinase \[CK\]), 3\*ULN mcmol/L (creatinine), \>1.5\*ULN mcmol/L (indirect bilirubin), and \>11.067 millimoles/L (urea). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if participant has values that changed "To Low and To High", so the percentages may not add to 100%. Baseline value is the latest pre-Tafenoquine dose assessment on Day 1.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Alkaline phosphatase: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Alkaline phosphatase: To within Range or No Change
|
14 Participants
|
5 Participants
|
21 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Alkaline phosphatase: To High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
CK: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
CK: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
CK: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Creatinine: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Indirect bilirubin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Indirect bilirubin: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Indirect bilirubin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Urea: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Urea: To within Range or No Change
|
14 Participants
|
5 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Urea: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: mITT Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Relapse is defined as positive blood smear with or without vivax malaria symptoms. A participant was considered to have demonstrated relapse-free efficacy if: a) Participant is slide positive for Plasmodium vivax (P. vivax) at Baseline. b) Participant showed initial clearance of P. vivax parasitemia defined as a negative slide at or before the Day 29 visit. c) Participant is not slide-positive for P. vivax at any assessment. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 4 months defined as a negative asexual P. vivax parasite slide at the first parasite assessment performed during study. Microbiologic-Intent-To-Treat (mITT) Population consisted of all participants who received a dose of study treatment (tafenoquine) and had microscopically-confirmed vivax parasitemia at Baseline.
Outcome measures
| Measure |
Tafenoquine 100 mg
n=14 Participants
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 Participants
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 Participants
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 Participants
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|
|
Number of Participants With Relapse-Free Efficacy at 4 Months
|
12 Participants
|
4 Participants
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Days 3, 15, 29 and 60 post dosePopulation: PK Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tafenoquine.
Outcome measures
Outcome data not reported
Adverse Events
Tafenoquine 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tafenoquine 100 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tafenoquine 150 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Tafenoquine 200 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tafenoquine 300 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tafenoquine 50 mg
Participants with weight band of \>=5 to \<=10 kg were planned to receive 50 mg tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 100 mg
n=14 participants at risk
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 participants at risk
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 participants at risk
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 participants at risk
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radius fracture
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
Other adverse events
| Measure |
Tafenoquine 50 mg
Participants with weight band of \>=5 to \<=10 kg were planned to receive 50 mg tafenoquine on Day 1. Participants were planned to receive Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 100 mg
n=14 participants at risk
Participants with weight band of \>10 to \<=20 kg received 100 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 150 mg
n=5 participants at risk
Participants with weight band of \>10 to \<=20 kg received 150 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 200 mg
n=22 participants at risk
Participants with weight band of \>20 to \<=35 kg received 200 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
Tafenoquine 300 mg
n=19 participants at risk
Participants with weight band of \>35 kg received 300 mg tafenoquine on Day 1. Participants received Chloroquine according to local/national guidelines to treat the blood stage of Plasmodium vivax.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
14.3%
2/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
60.0%
3/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
4.5%
1/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
31.6%
6/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
General disorders
Pyrexia
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
14.3%
2/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
22.7%
5/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Investigations
Blood methaemoglobin present
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
13.6%
3/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
13.6%
3/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
14.3%
2/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
4.5%
1/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
20.0%
1/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
4.5%
1/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
14.3%
2/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Pharyngitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
20.0%
1/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
4.5%
1/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Tonsillitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
40.0%
2/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
20.0%
1/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Viral infection
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
20.0%
1/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Impetigo
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Periorbital cellulitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Pyoderma
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Rhinitis
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Investigations
Haemoglobin decreased
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
14.3%
2/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Investigations
Blood alkaline phosphatase increased
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
4.5%
1/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
7.1%
1/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
10.5%
2/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/14 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/5 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
0.00%
0/22 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
5.3%
1/19 • Up to Day 120
Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). All-Cause Mortality, Non-SAEs and SAEs were not collected for tafenoquine 50 mg cohort as no participants were enrolled, because the study sites were unable to find any participants who met the inclusion/exclusion criteria for this cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER