Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-03-03 @ 3:38 PM
Study NCT ID:
NCT02497612
Status:
TERMINATED
Last Update Posted:
2022-03-24
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479230', 'term': 'ferroquine'}, {'id': 'C558165', 'term': 'artefenomel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early because all treatment arms met the futility criteria for efficacy during the pre-planned interim analysis. On 02-August-2018, recruitment in Asia was stopped due to lack of efficacy.'}}, 'adverseEventsModule': {'timeFrame': 'From Baseline up to Day 63', 'description': 'Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 77, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 79, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 77, 'seriousNumAtRisk': 96, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 74, 'seriousNumAtRisk': 91, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 75, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 65, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 49, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 45, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 37, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Electrocardiogram Qt Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Drug-Induced Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '64.7', 'upperLimit': '88.7'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '73.4', 'upperLimit': '92.9'}, {'value': '89.5', 'groupId': 'OG002', 'lowerLimit': '78.5', 'upperLimit': '96.0'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '81.6', 'upperLimit': '97.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\>Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5 degree Celsius (°C); or parasite count on Day 3\\>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT\\>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT\\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\<=5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '94.0'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '73.5', 'upperLimit': '100'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\>5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: Asian PP Population at Day 28 (APP28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Asian PP28 population: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP Population at Day 42 (PP42)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000', 'lowerLimit': '53.9', 'upperLimit': '82.8'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '90.9'}, {'value': '84.0', 'groupId': 'OG002', 'lowerLimit': '70.9', 'upperLimit': '92.8'}, {'value': '87.7', 'groupId': 'OG003', 'lowerLimit': '76.3', 'upperLimit': '94.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'ACPR: negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 42, or LPF: presence of parasitemia between Day 7 and 42 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\<=5 years PP42: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 42, excluding those who received rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP Population at Day 63 (PP63)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '78.8'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '88.2'}, {'value': '81.8', 'groupId': 'OG002', 'lowerLimit': '67.3', 'upperLimit': '91.8'}, {'value': '87.2', 'groupId': 'OG003', 'lowerLimit': '74.3', 'upperLimit': '95.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 63', 'description': 'ACPR: negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 63, or LPF: presence of parasitemia between Day 7 and 63 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\<=5 years PP63: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 63, excluding those who received rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28: African <=5 Years PP28 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '37.0', 'upperLimit': '61.6'}, {'value': '71.6', 'groupId': 'OG001', 'lowerLimit': '59.3', 'upperLimit': '82.0'}, {'value': '76.2', 'groupId': 'OG002', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '87.1', 'groupId': 'OG003', 'lowerLimit': '76.1', 'upperLimit': '94.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR was defined as negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28 or, LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish re-infection (new clone of parasite) or recrudescence.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years PP28 population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP42 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '51.6'}, {'value': '50.8', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '63.4'}, {'value': '61.0', 'groupId': 'OG002', 'lowerLimit': '47.4', 'upperLimit': '73.5'}, {'value': '68.9', 'groupId': 'OG003', 'lowerLimit': '55.7', 'upperLimit': '80.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'ACPR was defined as negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 42 or, LPF: presence of parasitemia between Day 7 and 42 and AT \\<37.5°C or having rescue therapy for malaria PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years PP42 population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP63 Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '47.8'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '33.7', 'upperLimit': '59.0'}, {'value': '57.6', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '70.4'}, {'value': '58.3', 'groupId': 'OG003', 'lowerLimit': '44.9', 'upperLimit': '70.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 63', 'description': 'Crude ACPR was defined as negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 63 or, LPF: presence of parasitemia between Day 7 and 63 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years PP63 population.'}, {'type': 'SECONDARY', 'title': 'Time to Re-emergence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '24.00', 'upperLimit': '63.00'}, {'value': '61.0', 'comment': 'Upper limit of 95% confidence interval (CI) was not estimable due to very low number of participants with the events.', 'groupId': 'OG001', 'lowerLimit': '43.00', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '64.0', 'groupId': 'OG003', 'lowerLimit': '63.00', 'upperLimit': '65.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 63', 'description': 'Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Re-emergence was confirmed by microscopy (positive blood smear). Kaplan-Maier method was used for estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\<=5 years modified Intent-To-Treat (mITT) population: all randomized African participants \\<=5 years with parasitological confirmed Plasmodium falciparum (P. falciparum) malaria at baseline, who received the single administration of OZ439/FQ and excluding participants who required rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Time to Recrudescence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 63', 'description': 'Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'type': 'SECONDARY', 'title': 'Time to Re-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '65.0', 'comment': '95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 63', 'description': 'Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differs from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance Time (PCT): African <=5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '24.23', 'upperLimit': '36.07'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '35.93', 'upperLimit': '36.10'}, {'value': '36.1', 'groupId': 'OG002', 'lowerLimit': '36.00', 'upperLimit': '48.00'}, {'value': '36.1', 'groupId': 'OG003', 'lowerLimit': '24.25', 'upperLimit': '36.42'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, in the data table "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African\\<=5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance Time: African >5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '18.00', 'upperLimit': '24.18'}, {'value': '24.3', 'groupId': 'OG001', 'lowerLimit': '18.07', 'upperLimit': '36.00'}, {'value': '24.3', 'groupId': 'OG002', 'lowerLimit': '12.23', 'upperLimit': '36.00'}, {'value': '27.2', 'groupId': 'OG003', 'lowerLimit': '6.15', 'upperLimit': '36.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'African \\>5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance Time: Asian PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.0', 'comment': 'Upper limit of 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG000', 'lowerLimit': '79.97', 'upperLimit': 'NA'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '53.93', 'upperLimit': '95.82'}, {'value': '79.8', 'comment': 'Upper limit of 95% CI was not estimable due to very low number of participants with the events.', 'groupId': 'OG002', 'lowerLimit': '36.00', 'upperLimit': 'NA'}, {'value': '72.2', 'groupId': 'OG003', 'lowerLimit': '60.08', 'upperLimit': '79.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Asian PP population: participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time (FCT): African <=5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '24.00'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '18.00'}, {'value': '1.0', 'comment': '95% CI was not estimable as all 4 participants had the same value.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '12.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first assessment. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed performed on African \\<=5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time: African >5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '18.00'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '2.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\>5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time: Asian PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Asian PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, \'0\' in "overall number of participants analyzed"=no participants were evaluable since they had paracetamol within 96 hours of study drug administration.'}, {'type': 'SECONDARY', 'title': 'Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'title': 'PRR24 (log10)', 'categories': [{'measurements': [{'value': '2.867', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '5.35'}, {'value': '3.011', 'groupId': 'OG001', 'lowerLimit': '1.10', 'upperLimit': '5.63'}, {'value': '2.397', 'groupId': 'OG002', 'lowerLimit': '1.25', 'upperLimit': '4.75'}, {'value': '2.587', 'groupId': 'OG003', 'lowerLimit': '1.52', 'upperLimit': '5.24'}]}]}, {'title': 'PRR48 (log10)', 'categories': [{'measurements': [{'value': '5.734', 'groupId': 'OG000', 'lowerLimit': '2.39', 'upperLimit': '10.69'}, {'value': '6.023', 'groupId': 'OG001', 'lowerLimit': '2.20', 'upperLimit': '11.27'}, {'value': '4.794', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '9.50'}, {'value': '5.174', 'groupId': 'OG003', 'lowerLimit': '3.04', 'upperLimit': '10.48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\<=5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'title': 'PRR24 (log10)', 'categories': [{'measurements': [{'value': '2.979', 'groupId': 'OG000', 'lowerLimit': '2.41', 'upperLimit': '4.30'}, {'value': '4.069', 'groupId': 'OG001', 'lowerLimit': '2.16', 'upperLimit': '5.00'}, {'value': '3.288', 'groupId': 'OG002', 'lowerLimit': '2.30', 'upperLimit': '4.81'}, {'value': '3.054', 'groupId': 'OG003', 'lowerLimit': '1.76', 'upperLimit': '5.59'}]}]}, {'title': 'PRR48 (log10)', 'categories': [{'measurements': [{'value': '5.957', 'groupId': 'OG000', 'lowerLimit': '4.83', 'upperLimit': '8.60'}, {'value': '8.137', 'groupId': 'OG001', 'lowerLimit': '4.32', 'upperLimit': '10.00'}, {'value': '6.577', 'groupId': 'OG002', 'lowerLimit': '4.61', 'upperLimit': '9.63'}, {'value': '6.108', 'groupId': 'OG003', 'lowerLimit': '3.52', 'upperLimit': '11.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on African \\>5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'title': 'PRR24 (log10)', 'categories': [{'measurements': [{'value': '1.167', 'groupId': 'OG000', 'lowerLimit': '1.01', 'upperLimit': '1.28'}, {'value': '1.125', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.44'}, {'value': '1.688', 'groupId': 'OG002', 'lowerLimit': '1.07', 'upperLimit': '3.12'}, {'value': '1.353', 'groupId': 'OG003', 'lowerLimit': '1.10', 'upperLimit': '1.65'}]}]}, {'title': 'PRR48 (log10)', 'categories': [{'measurements': [{'value': '2.335', 'groupId': 'OG000', 'lowerLimit': '2.03', 'upperLimit': '2.56'}, {'value': '2.250', 'groupId': 'OG001', 'lowerLimit': '1.99', 'upperLimit': '2.88'}, {'value': '3.377', 'groupId': 'OG002', 'lowerLimit': '2.14', 'upperLimit': '6.24'}, {'value': '2.705', 'groupId': 'OG003', 'lowerLimit': '2.21', 'upperLimit': '3.31'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Asian PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}]}, {'title': 'Any treatment-emergent SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any treatment-emergent AESI', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE led to treatment discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE led to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Day 63', 'description': "An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of the first dose of double-blind drug administration up to the Day 63. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on safety population which included all randomized participants who received at least 1 dose or part of a dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Artefenomel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1072', 'spread': '95', 'groupId': 'OG000'}, {'value': '936.7', 'spread': '91', 'groupId': 'OG001'}, {'value': '771.8', 'spread': '92', 'groupId': 'OG002'}, {'value': '797.8', 'spread': '119', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Cmax is the maximum observed plasma concentration of artefenomel.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population for OZ439 which included all participants who received OZ439 and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Artefenomel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.24', 'spread': '124', 'groupId': 'OG000'}, {'value': '12.41', 'spread': '127', 'groupId': 'OG001'}, {'value': '9.621', 'spread': '130', 'groupId': 'OG002'}, {'value': '9.605', 'spread': '147', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Area under the plasma concentration versus time curve from time zero to infinity.', 'unitOfMeasure': 'micrograms*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population for OZ439.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Apparent Total Clearance of Artefenomel From Plasma After Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and pharmacodynamic \\[PD\\]). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration (Vss/F) of Artefenomel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '148.1', 'spread': '52', 'groupId': 'OG000'}, {'value': '222.8', 'spread': '66', 'groupId': 'OG001'}, {'value': '350', 'spread': '55', 'groupId': 'OG002'}, {'value': '467.6', 'spread': '80', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Cmax is the maximum observed plasma concentration of Ferroquine.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the PK population for FQ which included all participants who received FQ and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Curve From Time 0 to Day 28 (AUC0-day28) of Ferroquine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.92', 'spread': '40', 'groupId': 'OG000'}, {'value': '22.56', 'spread': '48', 'groupId': 'OG001'}, {'value': '33.84', 'spread': '48', 'groupId': 'OG002'}, {'value': '46.4', 'spread': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2, 4, 6, 8, 12, 24, 48, 168, 336 and 672 hours postdose', 'description': 'Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).', 'unitOfMeasure': 'micrograms*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on PK population for FQ. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Apparent Total Clearance of Ferroquine From Plasma After Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration of Ferroquine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Blood/Plasma Ratio for Ferroquine and Its Active Metabolite SSR97213', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'OG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'OG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'OG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'reportingStatus': 'POSTED', 'populationDescription': 'Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since blood plasma ratio of active drug and metabolite was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams \\[mg\\]) oral suspension as follows: BW greater than or equal to (\\>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'FG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'FG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'FG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '93'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '91'}]}, {'type': 'Cohort 1: >14 Years to <70 Years', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Cohort 2: >5 Years to <=14 Years', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Cohort 3: >2 Years to <=5 Years', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'Cohort 4: >6 Months to <=2 Years', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Met >=1 anti-malarial treatment criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': "Participant's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': "Investigator's judgement", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Not eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study conducted at 12 active sites in 7 countries. Total of 806 participants were screened between 25 July 2015 and 22 July 2019, of which 377 were randomized to 1 of 4 treatment arms (via Integrated Web Recognition System using permuted block randomization schedules). 429 participants failed screening mainly due to meeting exclusion criteria.', 'preAssignmentDetails': 'In each arm, participants were divided in 4 cohorts (C):C1 (greater than \\[\\>\\] 14 years (yrs) to less than \\[\\<\\] 70 yrs); C2 (\\>5 yrs to less than or equal to \\[\\<=\\] 14 yrs );C3 (\\>2 yrs to \\<=5 yrs); C4 (\\>6 months to \\<=2 yrs). Day 0 (drug administration day, per protocol) was Day 1 for safety reporting as per Clinical Data Interchange Standards Consortium.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW \\>= 35 kg: FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.'}, {'id': 'BG001', 'title': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.'}, {'id': 'BG002', 'title': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.'}, {'id': 'BG003', 'title': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': '9.94', 'groupId': 'BG000'}, {'value': '6.97', 'spread': '8.97', 'groupId': 'BG001'}, {'value': '7.61', 'spread': '9.60', 'groupId': 'BG002'}, {'value': '7.68', 'spread': '10.44', 'groupId': 'BG003'}, {'value': '7.40', 'spread': '9.71', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '>6 months to <=2 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': '>2 to <=5 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '264', 'groupId': 'BG004'}]}, {'title': '>5 to <=14 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': '>14 to <18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': '>=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '356', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-10', 'size': 1565056, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-20T07:29', 'hasProtocol': True}, {'date': '2019-12-19', 'size': 5441597, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-20T07:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 377}}, 'statusModule': {'whyStopped': 'All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2015-07-08', 'resultsFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2015-07-13', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-22', 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28)', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\>Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5 degree Celsius (°C); or parasite count on Day 3\\>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT\\>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT\\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28)', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'measure': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: Asian PP Population at Day 28 (APP28)', 'timeFrame': 'Day 28', 'description': 'ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'measure': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP Population at Day 42 (PP42)', 'timeFrame': 'Day 42', 'description': 'ACPR: negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 42, or LPF: presence of parasitemia between Day 7 and 42 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'measure': 'Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP Population at Day 63 (PP63)', 'timeFrame': 'Day 63', 'description': 'ACPR: negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 63, or LPF: presence of parasitemia between Day 7 and 63 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.'}, {'measure': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28: African <=5 Years PP28 Population', 'timeFrame': 'Day 28', 'description': 'ACPR was defined as negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 28 or, LPF: presence of parasitemia between Day 7 and 28 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish re-infection (new clone of parasite) or recrudescence.'}, {'measure': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP42 Population', 'timeFrame': 'Day 42', 'description': 'ACPR was defined as negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 42 or, LPF: presence of parasitemia between Day 7 and 42 and AT \\<37.5°C or having rescue therapy for malaria PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.'}, {'measure': 'Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP63 Population', 'timeFrame': 'Day 63', 'description': 'Crude ACPR was defined as negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count \\> Day 0 irrespective of AT; or parasitemia at Day 3 with AT \\>=37.5°C; or parasite count on Day 3 \\>=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT \\>=37.5°C between Day 4 and 63 or, LPF: presence of parasitemia between Day 7 and 63 and AT \\<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.'}, {'measure': 'Time to Re-emergence', 'timeFrame': 'Up to Day 63', 'description': 'Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Re-emergence was confirmed by microscopy (positive blood smear). Kaplan-Maier method was used for estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'measure': 'Time to Recrudescence', 'timeFrame': 'Up to Day 63', 'description': 'Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.'}, {'measure': 'Time to Re-infection', 'timeFrame': 'Up to Day 63', 'description': 'Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differs from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.'}, {'measure': 'Parasite Clearance Time (PCT): African <=5 Years PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, in the data table "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'measure': 'Parasite Clearance Time: African >5 Years PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'measure': 'Parasite Clearance Time: Asian PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first negative film (up to Day 63)', 'description': 'PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken \\>=6 to \\<=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'measure': 'Fever Clearance Time (FCT): African <=5 Years PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first assessment. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.'}, {'measure': 'Fever Clearance Time: African >5 Years PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.'}, {'measure': 'Fever Clearance Time: Asian PP Population', 'timeFrame': 'From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)', 'description': 'FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature \\<37.5°C, confirmed by second assessment, taken within \\>=6 to \\<=12 hours of the first. Only participants with fever (adjusted body temperature \\>=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.'}, {'measure': 'Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.'}, {'measure': 'Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.'}, {'measure': 'Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population', 'timeFrame': '24 and 48 hours post dose', 'description': 'The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)', 'timeFrame': 'From Baseline up to Day 63', 'description': "An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of the first dose of double-blind drug administration up to the Day 63. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required."}, {'measure': 'Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Artefenomel', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Cmax is the maximum observed plasma concentration of artefenomel.'}, {'measure': 'Pharmacokinetics: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Artefenomel', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Area under the plasma concentration versus time curve from time zero to infinity.'}, {'measure': 'Pharmacokinetics (PK): Apparent Total Clearance of Artefenomel From Plasma After Oral Administration', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration (Vss/F) of Artefenomel', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine (Cmax)', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Cmax is the maximum observed plasma concentration of Ferroquine.'}, {'measure': 'Pharmacokinetics: Area Under the Curve From Time 0 to Day 28 (AUC0-day28) of Ferroquine', 'timeFrame': '2, 4, 6, 8, 12, 24, 48, 168, 336 and 672 hours postdose', 'description': 'Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).'}, {'measure': 'Pharmacokinetics: Apparent Total Clearance of Ferroquine From Plasma After Oral Administration', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration of Ferroquine', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Pharmacokinetics: Blood/Plasma Ratio for Ferroquine and Its Active Metabolite SSR97213', 'timeFrame': '2, 4, 6, 12, 24, 48, 72 and 672 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Plasmodium Falciparum Infection']}, 'referencesModule': {'references': [{'pmid': '34011358', 'type': 'DERIVED', 'citation': 'Adoke Y, Zoleko-Manego R, Ouoba S, Tiono AB, Kaguthi G, Bonzela JE, Duong TT, Nahum A, Bouyou-Akotet M, Ogutu B, Ouedraogo A, Macintyre F, Jessel A, Laurijssens B, Cherkaoui-Rbati MH, Cantalloube C, Marrast AC, Bejuit R, White D, Wells TNC, Wartha F, Leroy D, Kibuuka A, Mombo-Ngoma G, Ouattara D, Mugenya I, Phuc BQ, Bohissou F, Mawili-Mboumba DP, Olewe F, Soulama I, Tinto H; FALCI Study Group. A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria. Malar J. 2021 May 19;20(1):222. doi: 10.1186/s12936-021-03749-4.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.\n\nSecondary Objectives:\n\n* To evaluate the efficacy of OZ439/FQ:\n\n * To determine the incidence of recrudescence and re-infection.\n * To determine the time to relief of fever and parasite clearance.\n* To evaluate the safety and tolerability of OZ439/FQ in adults and children.\n* To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood.\n* To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.', 'detailedDescription': 'Total duration was 63 days for each participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nMale or female participant aged greater than (\\>) 6 months old and \\<70 years old:\n\n* Cohort 1 = 14 years \\< age \\<70 years and body weight greater than or equal to (\\>=) 35 kilogram (kg).\n* Cohort 2 = 5 years \\< age less than or equal to (\\<=) 14 years.\n* Cohort 3 = 2 years \\< age \\<=5 years.\n* Cohort 4 = 6 months \\< age \\<=2 years.\n\nBody weight \\>=5 kg and \\<=90 kg.\n\nPresence of mono-infection by Plasmodium falciparum with:\n\n* Fever, as defined by axillary temperature \\>=37.5 degrees Celsius (°C) or oral/rectal/tympanic temperature \\>=38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,\n* Microscopically (blood smear) confirmed parasite infection, ranging from 1000 to 100 000 asexual parasites/microliter of blood.\n\nInformed consent form signed by the participant or by the legally acceptable representative of the minor participant.\n\nExclusion criteria:\n\nPresence of severe malaria.\n\nAnti-malarial treatment:\n\n* With piperaquine-based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine (SP) within the previous 6 weeks (after their inhibition of new infections had fallen below 50%).\n* With amodiaquine or chloroquine within the previous 4 weeks.\n* With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days.\n* With any herbal products or traditional medicines, within the past 7 days.\n\nKnown history or evidence of clinically significant disorders.\n\nPrevious treatment within 5 times the half-life or within the last 14 days, whichever the longest which are: P-glycoprotein substrates, Cytochrome P450 (CYP) 2D6 main substrates and/or strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but inhibiting both CYP2C and CYP3A and/or CYP inducers.\n\nMixed plasmodium infection.\n\nSevere vomiting.\n\nSevere malnutrition.\n\nLaboratory parameters with clinically significant abnormalities and/or reaching critical values. For Liver Function Test. Aspartate aminotransferase (\\>2 \\[upper limit of normal\\] ULN), or alanine aminotransferase (\\>2 ULN) or total bilirubin \\>1.5 ULN.\n\nPresence of Hepatitis A Immunoglobulin M, Hepatitis B surface antigen or Hepatitis C antibody.\n\nHad received an investigational drug within the past 4 weeks.\n\nPrevious participation in any malaria vaccine study or received malaria vaccine in any other circumstance.\n\nMeasles and yellow fever vaccine injection within the last 15 days and or planned for the 28 days after randomization.\n\nFemale participant of child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study.\n\nPositive serum or urine beta-human chorionic gonadotropin pregnancy test at study screening for female participants of childbearing potential.\n\nBreastfeeding women.\n\nMale participant having a partner of child bearing potential not willing to use an effective method of birth control during the study treatment period.\n\nSplenectomized participants or presence of surgical scar on left hypochondrium. Participant unable to drink.\n\nKnown history of hypersensitivity, allergic or anaphylactoid reactions to ferroquine or other amino-quinolines or to OZ439 or OZ277 or to any of the excipients.\n\nFamily history of sudden death or of congenital prolongation of the Corrected QT (QTc) interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval e.g., participants with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.\n\nQTc using Fridericia's formula \\>450 millisecond at screening or pre-dose.\n\nHypokalemia (\\<3.5 millimoles per liter \\[mmol/L\\]), hypocalcemia (\\<2.0 mmol/L) or hypomagnesemia (\\<0.5 mmol/L) at screening or pre-dose.\n\nAny treatment known to induce a lengthening of QT interval.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02497612', 'acronym': 'FALCI', 'briefTitle': 'To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria', 'orgStudyIdInfo': {'id': 'DRI12805'}, 'secondaryIdInfos': [{'id': 'U1111-1155-7960', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams \\[mg\\]) oral suspension as follows: BW greater than or equal to (\\>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW \\>=24 kg to less than (\\<) 35 kg: FQ 300 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 200 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 150 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 100 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 75 mg + OZ439 150 mg.', 'interventionNames': ['Drug: Ferroquine SSR97193', 'Drug: Artefenomel', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 600 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 450 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 300 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 225 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 150 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 115 mg + OZ439 150 mg.', 'interventionNames': ['Drug: Ferroquine SSR97193', 'Drug: Artefenomel', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 900 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 675 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 450 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 335 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 225 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 170 mg + OZ439 150 mg.', 'interventionNames': ['Drug: Ferroquine SSR97193', 'Drug: Artefenomel', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'description': 'On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW \\>= 35 kg: FQ 1200 mg + OZ439 800 mg; BW \\>=24 kg to \\<35 kg: FQ 900 mg + OZ439 600 mg; BW \\>=15 kg to \\<24 kg: FQ 600 mg + OZ439 400 mg; BW \\>=10 kg to \\<15 kg: FQ 450 mg + OZ439 300 mg; BW \\>=7 kg to \\<10 kg: FQ 300 mg + OZ439 200 mg; \\>=5 kg to \\<7kg: FQ 225 mg + OZ439 150 mg.', 'interventionNames': ['Drug: Ferroquine SSR97193', 'Drug: Artefenomel', 'Other: Placebo']}], 'interventions': [{'name': 'Ferroquine SSR97193', 'type': 'DRUG', 'description': 'Pharmaceutical form:Capsules Route of administration: oral', 'armGroupLabels': ['Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)']}, {'name': 'Artefenomel', 'type': 'DRUG', 'description': 'Pharmaceutical form:Granules for suspension Route of administration: oral', 'armGroupLabels': ['Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Capsules. Placebo capsules were used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No participant received placebo only.', 'armGroupLabels': ['Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg)', 'Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cotonou', 'country': 'Benin', 'facility': 'Investigational Site Number 204001', 'geoPoint': {'lat': 6.36536, 'lon': 2.41833}}, {'city': 'Comoé', 'country': 'Burkina Faso', 'facility': 'Investigational Site Number 854002'}, {'city': 'Niangoloko', 'country': 'Burkina Faso', 'facility': 'Investigational Site Number 854003', 'geoPoint': {'lat': 10.28333, 'lon': -4.91667}}, {'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Investigational Site Number 854001', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Lambaréné', 'country': 'Gabon', 'facility': 'Investigational Site Number 266002', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}, {'city': 'Libreville', 'country': 'Gabon', 'facility': 'Investigational Site Number 266001', 'geoPoint': {'lat': 0.39241, 'lon': 9.45356}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Investigational Site Number 404003', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Investigational Site Number 404002', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'city': 'Chokwé', 'country': 'Mozambique', 'facility': 'Investigational Site Number 508001', 'geoPoint': {'lat': -24.53333, 'lon': 32.98333}}, {'city': 'Tororo', 'country': 'Uganda', 'facility': 'Investigational Site Number 800002', 'geoPoint': {'lat': 0.69299, 'lon': 34.18085}}, {'city': 'Bình Phước', 'country': 'Vietnam', 'facility': 'Investigational Site Number 704003', 'geoPoint': {'lat': 10.66438, 'lon': 106.77636}}, {'city': 'Pleiku', 'country': 'Vietnam', 'facility': 'Investigational Site Number 704004', 'geoPoint': {'lat': 13.98333, 'lon': 108.0}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medicines for Malaria Venture', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}