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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines. Sites will have up to 48 hours to obtain consent. Once full consent is provided, all subjects will be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose on Day 1. All study medication should be taken with food. After the treatment period, subjects will attend up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and 120). The main cohort will consist of subjects aged >=2 years to <16 years with no restriction on gender. Subjects will be dosed according to four weight bands. Within the total of 60 enrolled pediatric subjects, a second cohort of up to 6 infants aged >=6 months to <2 years (weighing >=5 kilogram [kg]) will be recruited following completion of a planned first interim analysis. An interim analysis will be conducted once sufficient data from 16 subjects is available to assess pharmacokinetic (PK) and safety parameters. If needed, a second interim analysis will be conducted after a total of 32 subjects have enrolled. The primary objective of this PK bridging study is to adequately characterize the systemic TQ exposure in the pediatric population in order to identify appropriate doses that achieve a similar exposure to that of the TQ adult dose of 300 milligram (mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tafenoquine 50 mg | Experimental | Subjects with weight band of >=5 to <=10 kilogram (kg) will receive 50 mg tafenoquine on Day 1. Subject may receive CQ per local/national guidelines. |
|
| Tafenoquine 100 mg | Experimental | Subjects with weight band of >10 to <=20 kg will receive 100 mg tafenoquine on Day 1. Subject may receive CQ per local/national guidelines. |
|
| Tafenoquine 150 mg | Experimental | Subjects with weight band of >10 to <=20 kg will receive 150 mg tafenoquine on Day 1. Subject may receive CQ per local/national guidelines. |
|
| Tafenoquine 200 mg | Experimental | Subjects with weight band of >20 to <=35 kg will receive 200 mg tafenoquine on Day 1. Subject may receive CQ per local/national guidelines. |
|
| Tafenoquine 300 mg | Experimental | Subjects with weight band of >35 kg will receive 300 mg tafenoquine on Day 1. Subject may receive CQ per local/national guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafenoquine | Drug | Tafenoquine tablet is supplied as film-coated tablet (100 mg, 150 mg, 200 mg and 300 mg) and fast-dispersing film coated tablet (50 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Days 3, 15, 29 and 60 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Gastrointestinal Adverse Events | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | MonterÃa | Colombia | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34871570 | Derived | Velez ID, Hien TT, Green JA, Martin A, Sharma H, Rousell VM, Breton JJ, Ernest TB, Rolfe K, Taylor M, Mohamed K, Jones SW, Chau NH, Hoa NT, Duparc S, Tan LK, Goyal N. Tafenoquine exposure assessment, safety, and relapse prevention efficacy in children with Plasmodium vivax malaria: open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 trial. Lancet Child Adolesc Health. 2022 Feb;6(2):86-95. doi: 10.1016/S2352-4642(21)00328-X. Epub 2021 Dec 3. |
Not provided
Not provided
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.
This was an open label, Phase 2, multicenter study to assess the pharmacokinetics, safety and efficacy of tafenoquine in participants with Plasmodium Vivax Malaria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The tafenoquine 50 mg cohort 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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Tafenoquine 100 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | PK Population. | Posted | Median | Full Range | Hours*microgram per milliliter | Days 3, 15, 29 and 60 post dose |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2018 | Sep 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2020 | Sep 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016780 | Malaria, Vivax |
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C055852 | tafenoquine |
| D002738 | Chloroquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Chloroquine | Drug | Subjects may receive chloroquine according to local/national treatment guidelines. |
|
| Up to Day 120 |
| Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days | 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. | Baseline and up to Day 10 |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | 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. | Up to Day 120 |
| Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | 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. | Baseline (Day 1) and up to Day 8 |
| Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | 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. | Baseline (Day 1) and up to Day 8 |
| Number of Participants With Relapse-Free Efficacy at 4 Months | 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. | 4 months |
| AUC(0-infinity) of Tafenoquine by Weight Band in Participants Aged >=6 Months to <2 Years (Weighing >=5 kg) | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tafenoquine. | Days 3, 15, 29 and 60 post dose |
| Hanoi |
| 100000 |
| Vietnam |
| GSK Investigational Site | Ho Chi Minh City | 700000 | Vietnam |
| GSK Investigational Site | Ho Chi Minh City | Vietnam |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Safety Population consisted of all participants who received at least one dose of study medication (tafenoquine). | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Number of Participants With Gastrointestinal Adverse Events | 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). | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With Hemoglobin Decline From Baseline Over First 10 Days | 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. | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | Baseline and up to Day 10 |
|
|
|
| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | 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. | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | Up to Day 120 |
|
|
|
| Secondary | Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline | 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. | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to Day 8 |
|
|
|
| Secondary | Number of Participants With Worst Case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline | 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. | Safety Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to Day 8 |
|
|
|
| Secondary | Number of Participants With Relapse-Free Efficacy at 4 Months | 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. | mITT Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | AUC(0-infinity) of Tafenoquine by Weight Band in Participants Aged >=6 Months to <2 Years (Weighing >=5 kg) | Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tafenoquine. | PK Population. Data is not presented for the cohort Tafenoquine 50 mg; as no participants were enrolled in this cohort. | Posted | Days 3, 15, 29 and 60 post dose |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 10 | 14 |
| EG002 | 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. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG003 | 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. | 0 | 22 | 0 | 22 | 10 | 22 |
| EG004 | 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. | 0 | 19 | 1 | 19 | 13 | 19 |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Blood methaemoglobin present | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
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.
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 | Heterocyclic Compounds |
| Abdominal pain |
|
| Diarrhea |
|
| Gastrointestinal disorder |
|
| Epigastric discomfort |
|
| Nausea |
|
| >20 g/L to <=30 g/L |
|
| >30 g/L or >=30% |
|
| SAEs |
|
| Eosinophils: To within Range or No Change |
|
| Eosinophils: To High |
|
| Lymphocytes: To Low |
|
| Lymphocytes: To within Range or No Change |
|
| Lymphocytes: To High |
|
| Platelet count: To Low |
|
| Platelet count: To within Range or No Change |
|
| Platelet count: To High |
|
| Reticulocyte count: To Low |
|
| Reticulocyte count: To within Range or No Change |
|
| Reticulocyte count: To High |
|
| ALT: To within Range or No Change |
|
| ALT: To High |
|
| Alkaline phosphatase: To Low |
|
| Alkaline phosphatase: To within Range or No Change |
|
| Alkaline phosphatase: To High |
|
| AST: To Low |
|
| AST: To within Range or No Change |
|
| AST: To High |
|
| Bilirubin: To Low |
|
| Bilirubin: To within Range or No Change |
|
| Bilirubin: To High |
|
| CK: To Low |
|
| CK: To within Range or No Change |
|
| CK: To High |
|
| Creatinine: To Low |
|
| Creatinine: To within Range or No Change |
|
| Creatinine: To High |
|
| Indirect bilirubin: To Low |
|
| Indirect bilirubin: To within Range or No Change |
|
| Indirect bilirubin: To High |
|
| Urea: To Low |
|
| Urea: To within Range or No Change |
|
| Urea: To High |
|