Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-05 @ 8:35 PM
Study NCT ID:
NCT00677833
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Zambia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}], 'ancestors': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Cohort 1 was a screening cohort, meant for safety evaluation, but not included in the efficacy assessments.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between \\>=5 years of age and \\<=12 years of age.', 'otherNumAtRisk': 55, 'otherNumAffected': 40, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 1: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \\>=5 years of age and \\<=12 years of age.', 'otherNumAtRisk': 51, 'otherNumAffected': 36, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.', 'otherNumAtRisk': 124, 'otherNumAffected': 103, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.', 'otherNumAtRisk': 131, 'otherNumAffected': 99, 'seriousNumAtRisk': 131, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Conjunctival pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Infection parasitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 9}, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.27', 'groupId': 'OG000', 'lowerLimit': '82.77', 'upperLimit': '95.77'}, {'value': '98.37', 'groupId': 'OG001', 'lowerLimit': '95.59', 'upperLimit': '100.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.10', 'ciLowerLimit': '-16.02', 'ciUpperLimit': '-2.18', 'groupDescription': 'Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \\>= -10% points.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures \\[LCF\\] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter \\[mcL\\];fever/history of fever \\>=38 degree Celsius\\[C\\] \\[rectal\\],37.2 degree C \\[axillary\\] or \\>=37.5 degree C \\[oral\\] within last 24 hours).Participants in Ivory Coast center excluded from analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.08', 'groupId': 'OG000', 'lowerLimit': '87.32', 'upperLimit': '98.84'}, {'value': '99.16', 'groupId': 'OG001', 'lowerLimit': '96.97', 'upperLimit': '100.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.08', 'ciLowerLimit': '-12.10', 'ciUpperLimit': '-0.05', 'groupDescription': 'Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \\>= -10% points.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PCR-corrected ACPR in the mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '94.17', 'groupId': 'OG000', 'lowerLimit': '89.55', 'upperLimit': '98.78'}, {'value': '99.21', 'groupId': 'OG001', 'lowerLimit': '97.25', 'upperLimit': '100.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '92.47', 'groupId': 'OG000', 'lowerLimit': '87.30', 'upperLimit': '97.64'}, {'value': '99.21', 'groupId': 'OG001', 'lowerLimit': '97.24', 'upperLimit': '100.00'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '91.59', 'groupId': 'OG000', 'lowerLimit': '86.04', 'upperLimit': '97.14'}, {'value': '98.37', 'groupId': 'OG001', 'lowerLimit': '95.65', 'upperLimit': '100.00'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '89.27', 'groupId': 'OG000', 'lowerLimit': '82.68', 'upperLimit': '95.86'}, {'value': '96.19', 'groupId': 'OG001', 'lowerLimit': '91.85', 'upperLimit': '100.00'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '87.55', 'groupId': 'OG000', 'lowerLimit': '80.08', 'upperLimit': '95.03'}, {'value': '96.19', 'groupId': 'OG001', 'lowerLimit': '91.79', 'upperLimit': '100.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.04', 'ciLowerLimit': '-9.93', 'ciUpperLimit': '-0.15', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.74', 'ciLowerLimit': '-12.15', 'ciUpperLimit': '-1.32', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.78', 'ciLowerLimit': '-12.82', 'ciUpperLimit': '-0.75', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.92', 'ciLowerLimit': '-14.59', 'ciUpperLimit': '0.76', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.63', 'ciLowerLimit': '-17.08', 'ciUpperLimit': '-0.18', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 35, 42', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PCR-corrected ACPR in PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '98.25', 'groupId': 'OG000', 'lowerLimit': '95.39', 'upperLimit': '100.00'}, {'value': '100.00', 'comment': 'Confidence interval was not calculable as standard error for 100% rate could not be estimated from Kaplan-Meier method.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '96.46', 'groupId': 'OG000', 'lowerLimit': '92.59', 'upperLimit': '100.00'}, {'value': '100.00', 'comment': 'Confidence interval was not calculable as standard error for 100% rate could not be estimated from Kaplan-Meier method.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '95.53', 'groupId': 'OG000', 'lowerLimit': '91.10', 'upperLimit': '99.96'}, {'value': '99.16', 'groupId': 'OG001', 'lowerLimit': '97.03', 'upperLimit': '100.00'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '93.08', 'groupId': 'OG000', 'lowerLimit': '87.22', 'upperLimit': '98.95'}, {'value': '96.96', 'groupId': 'OG001', 'lowerLimit': '92.90', 'upperLimit': '100.00'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '91.29', 'groupId': 'OG000', 'lowerLimit': '84.31', 'upperLimit': '98.28'}, {'value': '96.96', 'groupId': 'OG001', 'lowerLimit': '92.84', 'upperLimit': '100.00'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.63', 'ciLowerLimit': '-8.40', 'ciUpperLimit': '1.14', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.', 'statisticalMethod': 'Kaplan-Meier, curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.87', 'ciLowerLimit': '-10.79', 'ciUpperLimit': '3.04', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.', 'statisticalMethod': 'Kaplan-Meier, curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.66', 'ciLowerLimit': '-13.55', 'ciUpperLimit': '2.22', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.', 'statisticalMethod': 'Kaplan-Meier, curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 35, 42', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PCR-uncorrected ACPR in the mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '94.17', 'groupId': 'OG000', 'lowerLimit': '89.55', 'upperLimit': '98.78'}, {'value': '99.21', 'groupId': 'OG001', 'lowerLimit': '97.25', 'upperLimit': '100.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '89.08', 'groupId': 'OG000', 'lowerLimit': '83.05', 'upperLimit': '95.11'}, {'value': '96.79', 'groupId': 'OG001', 'lowerLimit': '93.28', 'upperLimit': '100.00'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '67.87', 'groupId': 'OG000', 'lowerLimit': '59.02', 'upperLimit': '76.72'}, {'value': '82.96', 'groupId': 'OG001', 'lowerLimit': '75.91', 'upperLimit': '90.01'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '51.55', 'groupId': 'OG000', 'lowerLimit': '42.07', 'upperLimit': '61.02'}, {'value': '73.31', 'groupId': 'OG001', 'lowerLimit': '65.10', 'upperLimit': '81.52'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '44.67', 'groupId': 'OG000', 'lowerLimit': '35.24', 'upperLimit': '54.11'}, {'value': '62.91', 'groupId': 'OG001', 'lowerLimit': '54.00', 'upperLimit': '71.82'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '37.80', 'groupId': 'OG000', 'lowerLimit': '28.58', 'upperLimit': '47.02'}, {'value': '56.29', 'groupId': 'OG001', 'lowerLimit': '47.12', 'upperLimit': '65.46'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.04', 'ciLowerLimit': '-9.93', 'ciUpperLimit': '-0.15', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.71', 'ciLowerLimit': '-14.54', 'ciUpperLimit': '-0.88', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.09', 'ciLowerLimit': '-26.24', 'ciUpperLimit': '-3.94', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.76', 'ciLowerLimit': '-34.14', 'ciUpperLimit': '-9.39', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.24', 'ciLowerLimit': '-31.05', 'ciUpperLimit': '-5.43', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.49', 'ciLowerLimit': '-31.33', 'ciUpperLimit': '-5.65', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PCR-uncorrected ACPR in PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '98.25', 'groupId': 'OG000', 'lowerLimit': '95.39', 'upperLimit': '100.00'}, {'value': '100.00', 'comment': 'Confidence interval not calculable when rate is 100%.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '92.89', 'groupId': 'OG000', 'lowerLimit': '87.69', 'upperLimit': '98.08'}, {'value': '97.56', 'groupId': 'OG001', 'lowerLimit': '94.42', 'upperLimit': '100.00'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '70.56', 'groupId': 'OG000', 'lowerLimit': '61.67', 'upperLimit': '79.45'}, {'value': '83.62', 'groupId': 'OG001', 'lowerLimit': '76.65', 'upperLimit': '90.60'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '54.28', 'groupId': 'OG000', 'lowerLimit': '44.57', 'upperLimit': '63.98'}, {'value': '73.90', 'groupId': 'OG001', 'lowerLimit': '65.71', 'upperLimit': '82.08'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '47.04', 'groupId': 'OG000', 'lowerLimit': '37.31', 'upperLimit': '56.77'}, {'value': '63.41', 'groupId': 'OG001', 'lowerLimit': '54.49', 'upperLimit': '72.34'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '39.80', 'groupId': 'OG000', 'lowerLimit': '30.24', 'upperLimit': '49.36'}, {'value': '56.74', 'groupId': 'OG001', 'lowerLimit': '47.54', 'upperLimit': '65.94'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.67', 'ciLowerLimit': '-10.60', 'ciUpperLimit': '1.25', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.07', 'ciLowerLimit': '-24.21', 'ciUpperLimit': '-1.92', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.62', 'ciLowerLimit': '-32.16', 'ciUpperLimit': '-7.08', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.38', 'ciLowerLimit': '-29.42', 'ciUpperLimit': '-3.33', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)-(AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR Percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.94', 'ciLowerLimit': '-30.04', 'ciUpperLimit': '-3.83', 'groupDescription': 'A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \\[(AZ-CQ)- (AL)\\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.', 'statisticalMethod': 'Kaplan-Meier curves', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.83', 'groupId': 'OG000'}, {'value': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 3', 'description': 'ETF defined as participants who met the following criteria:\n\n1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia\n2. Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.\n3. Parasitemia (P. falciparum) on Day 3 with fever or\n4. Last available P. falciparum parasite count on Day 3 \\>=25% of the first available parasite count on Day 0 (Baseline).\n\nPCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, participants in Ivory Coast center were excluded from mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ETF in PP Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 3', 'description': 'ETF defined as participants who met the following criteria:\n\n1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia\n2. Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.\n3. Parasitemia (P.falciparum) on Day 3 with fever or\n4. Last available P.falciparum parasite count on Day 3 \\>=25% of the first available parasite count on Day 0 (Baseline).\n\nPCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population, participants in Ivory Coast center were excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LCF included participants who met any of the following criteria:\n\n1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)\n2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, participants in Ivory Coast center were excluded from mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LCF in PP Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LCF included participants who met any of the following criteria:\n\n1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)\n2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population, participants in Ivory Coast center were excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000'}, {'value': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000'}, {'value': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000'}, {'value': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000'}, {'value': '2.38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, participants in Ivory Coast center were excluded from mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LPF in PP Population (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.75', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 21', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000'}, {'value': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '4.39', 'groupId': 'OG000'}, {'value': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Day 35', 'categories': [{'measurements': [{'value': '4.39', 'groupId': 'OG000'}, {'value': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'Day 42', 'categories': [{'measurements': [{'value': '5.26', 'groupId': 'OG000'}, {'value': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population, participants in Ivory Coast center were excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7 (n=120, 128)', 'categories': [{'measurements': [{'value': '93.33', 'groupId': 'OG000'}, {'value': '99.22', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (n=120, 127)', 'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG000'}, {'value': '99.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 21 (n=120, 128)', 'categories': [{'measurements': [{'value': '90.83', 'groupId': 'OG000'}, {'value': '98.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=120, 127)', 'categories': [{'measurements': [{'value': '89.17', 'groupId': 'OG000'}, {'value': '98.43', 'groupId': 'OG001'}]}]}, {'title': 'Day 35 (n=120, 128)', 'categories': [{'measurements': [{'value': '89.17', 'groupId': 'OG000'}, {'value': '96.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (n=120, 127)', 'categories': [{'measurements': [{'value': '88.33', 'groupId': 'OG000'}, {'value': '96.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.89', 'ciLowerLimit': '-11.02', 'ciUpperLimit': '-0.75', 'groupDescription': 'Day 7', 'statisticalMethod': 'large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.55', 'ciLowerLimit': '-13.14', 'ciUpperLimit': '-1.95', 'groupDescription': 'Day 14', 'statisticalMethod': 'large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.60', 'ciLowerLimit': '-13.61', 'ciUpperLimit': '-1.60', 'groupDescription': 'Day 21', 'statisticalMethod': 'large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.26', 'ciLowerLimit': '-15.64', 'ciUpperLimit': '-2.87', 'groupDescription': 'Day 28', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.71', 'ciLowerLimit': '-14.45', 'ciUpperLimit': '-0.97', 'groupDescription': 'Day 35', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.52', 'ciLowerLimit': '-15.43', 'ciUpperLimit': '-1.60', 'groupDescription': 'Day 42', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, 14, 21, 28, 35, 42', 'description': 'Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Gametocytologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Day 7 (n=122, 129)', 'categories': [{'measurements': [{'value': '81.97', 'groupId': 'OG000'}, {'value': '91.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 14 (n=122, 130)', 'categories': [{'measurements': [{'value': '81.15', 'groupId': 'OG000'}, {'value': '91.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 21 (n=122, 130)', 'categories': [{'measurements': [{'value': '80.33', 'groupId': 'OG000'}, {'value': '93.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=122, 130)', 'categories': [{'measurements': [{'value': '81.97', 'groupId': 'OG000'}, {'value': '93.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 35 (n=122, 130)', 'categories': [{'measurements': [{'value': '81.97', 'groupId': 'OG000'}, {'value': '92.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 42 (n=122, 130)', 'categories': [{'measurements': [{'value': '80.33', 'groupId': 'OG000'}, {'value': '91.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.51', 'ciLowerLimit': '-18.27', 'ciUpperLimit': '-0.74', 'groupDescription': 'Day 7', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.39', 'ciLowerLimit': '-19.23', 'ciUpperLimit': '-1.55', 'groupDescription': 'Day 14', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.75', 'ciLowerLimit': '-21.45', 'ciUpperLimit': '-4.04', 'groupDescription': 'Day 21', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-19.62', 'ciUpperLimit': '-2.60', 'groupDescription': 'Day 28', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.34', 'ciLowerLimit': '-18.97', 'ciUpperLimit': '-1.71', 'groupDescription': 'Day 35', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.21', 'ciLowerLimit': '-20.14', 'ciUpperLimit': '-2.28', 'groupDescription': 'Day 42', 'statisticalMethod': 'Large sample approximation to binomial', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "N"= participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.000', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '504'}, {'value': '24.000', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '336'}]}]}], 'analyses': [{'pValue': '0.2564', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Time to event data was analyzed using the Kaplan-Meier curve.', 'statisticalMethod': 'Kaplan-Meier, log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Day 42', 'description': 'Calculated as time of first occurrence of two consecutive time points with temperature less than (\\<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or \\<37.5 degrees C/99.5 degrees F (oral).', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, including participants in the Ivory Coast center.'}, {'type': 'SECONDARY', 'title': 'Asexual Plasmodium Falciparum Parasite Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.000', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '504'}, {'value': '24.000', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '48'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Time to event data was analyzed using the Kaplan-Meier curve.', 'statisticalMethod': 'Kaplan-Meier, log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Day 42', 'description': 'Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, including participants in the Ivory Coast center.'}, {'type': 'SECONDARY', 'title': 'Nadir Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.63', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '9.82', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 through Day 3', 'description': 'Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.', 'unitOfMeasure': 'grams per deciliter (g/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, including participants in the Ivory Coast center.'}, {'type': 'SECONDARY', 'title': 'Change From Nadir Hemoglobin Level at Days 14, 28, and 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'title': 'Change at Day 14 (n=122, 127)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 28 (n=122, 127)', 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 42 (n=122, 128)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14, 28, 42', 'description': 'Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "N" = number of participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Recurrence of Parasitemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '42'}, {'value': 'NA', 'comment': 'Median time to recurrence could not be calculated for participants in the Artemether-Lumefantrine treatment groups since fewer than 50% of the participants experienced recurrent parasitemia during the study.', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '43'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Time to event data was analyzed using the Kaplan-Meier curve.', 'statisticalMethod': 'Kaplan-Meier, log rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0) to Day 42', 'description': 'Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population, including participants in the Ivory Coast center.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'timeFrame': 'Baseline to Day 42', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not analyzed as per change in planned analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PfCRT in True Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'OG001', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'timeFrame': 'Baseline to Day 42', 'description': 'A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this outcome measure was not analyzed as per change in planned analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (\\>=) 5 years of age and less than or equal to (\\<=) 12 years of age.'}, {'id': 'FG001', 'title': 'Cohort 1: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \\>=5 years of age and \\<=12 years of age.'}, {'id': 'FG002', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'FG003', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited in 2 age-based Cohorts. Cohort 1=participants between 5-12 years of age, assumed to have some degree of immunity and at less risk for untoward outcome. After demonstration of successful treatment, safety and tolerability in Cohort 1, participants between \\>=6 months of age to \\<=59 months of age were enrolled in Cohort 2.', 'preAssignmentDetails': 'Participants were enrolled in 2 cohorts based on different age criteria. All participants in Cohort 1 met the age criteria where as 3 participants enrolled in Cohort 2 were slightly older than 5 years (by less than 2 months).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '361', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between \\>=5 years of age and \\<=12 years of age.'}, {'id': 'BG001', 'title': 'Cohort 1: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2.\n\nCohort 1 included participants between \\>=5 years of age and \\<=12 years of age.'}, {'id': 'BG002', 'title': 'Cohort 2: Azithromycin + Chloroquine', 'description': 'Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \\[mg\\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'BG003', 'title': 'Cohort 2: Artemether + Lumefantrine', 'description': 'Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \\>=6 months of age to \\<=59 months of age.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 months - less than 5 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}]}, {'title': '5 years - 12 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2010-11-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2008-05-12', 'dispFirstSubmitQcDate': '2010-11-05', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2008-05-12', 'dispFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-27', 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population', 'timeFrame': 'Day 28', 'description': 'ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures \\[LCF\\] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population', 'timeFrame': 'Day 28', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With PCR-corrected ACPR in the mITT Population', 'timeFrame': 'Days 7, 14, 21, 35, 42', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With PCR-corrected ACPR in PP Population', 'timeFrame': 'Days 7, 14, 21, 35, 42', 'description': 'ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With PCR-uncorrected ACPR in the mITT Population', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.'}, {'measure': 'Percentage of Participants With PCR-uncorrected ACPR in PP Population', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.'}, {'measure': 'Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)', 'timeFrame': 'Day 0 up to Day 3', 'description': 'ETF defined as participants who met the following criteria:\n\n1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia\n2. Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.\n3. Parasitemia (P. falciparum) on Day 3 with fever or\n4. Last available P. falciparum parasite count on Day 3 \\>=25% of the first available parasite count on Day 0 (Baseline).\n\nPCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With ETF in PP Population (PCR-corrected)', 'timeFrame': 'Day 0 up to Day 3', 'description': 'ETF defined as participants who met the following criteria:\n\n1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia\n2. Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature.\n3. Parasitemia (P.falciparum) on Day 3 with fever or\n4. Last available P.falciparum parasite count on Day 3 \\>=25% of the first available parasite count on Day 0 (Baseline).\n\nPCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected)', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LCF included participants who met any of the following criteria:\n\n1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)\n2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With LCF in PP Population (PCR-corrected)', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LCF included participants who met any of the following criteria:\n\n1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8)\n2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected)', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With LPF in PP Population (PCR-corrected)', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With Asexual Parasitologic Response (PCR-corrected)', 'timeFrame': 'Day 7, 14, 21, 28, 35, 42', 'description': 'Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Percentage of Participants With Gametocytologic Response', 'timeFrame': 'Days 7, 14, 21, 28, 35, 42', 'description': 'Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.'}, {'measure': 'Fever Clearance Time', 'timeFrame': 'Baseline to Day 42', 'description': 'Calculated as time of first occurrence of two consecutive time points with temperature less than (\\<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or \\<37.5 degrees C/99.5 degrees F (oral).'}, {'measure': 'Asexual Plasmodium Falciparum Parasite Clearance Time', 'timeFrame': 'Baseline to Day 42', 'description': 'Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.'}, {'measure': 'Nadir Hemoglobin Level', 'timeFrame': 'Day 0 through Day 3', 'description': 'Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.'}, {'measure': 'Change From Nadir Hemoglobin Level at Days 14, 28, and 42', 'timeFrame': 'Day 14, 28, 42', 'description': 'Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.'}, {'measure': 'Time to Recurrence of Parasitemia', 'timeFrame': 'Baseline (Day 0) to Day 42', 'description': 'Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).'}, {'measure': 'Number of Participants With Recurrent Parasitemia Versus Baseline Plasmodium Falciparum Chloroquine Resistance Transporter (PfCRT) Status', 'timeFrame': 'Baseline to Day 42'}, {'measure': 'Percentage of Participants With PfCRT in True Failures', 'timeFrame': 'Baseline to Day 42', 'description': 'A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['P. Falciparum Malaria', 'drug treatment', 'clinical trial'], 'conditions': ['Malaria, Falciparum']}, 'referencesModule': {'references': [{'pmid': '25881046', 'type': 'DERIVED', 'citation': 'Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661157&StudyName=Azithromycin%20Plus%20Chloroquine%20Versus%20Artemether-Lumefantrine%20For%20The%20Treatment%20Of%20Uncomplicated%20P.%20Falciparum%20Malaria%20In%20Children%20In%20Africa', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Girls and boys ≥5 years to ≤12 years (Cohort 1); and ≥6 to ≤59 months of age (Cohort 2) with uncomplicated, symptomatic malaria as indicated by the presence of the following:\n* Blood smears positive for monoinfection with P. falciparum and asexual parasitemia between 1000 -100,000 parasites/µL;\n* Documented fever (38.0°C/100.4°F rectal or tympanic; 37.2°C/99.0°F axillary or 37.5°C/99.5°F oral) or history of fever (as reported by the legally acceptable representative) within the prior 24 hours;\n* Appropriate for outpatient treatment;\n* Blood glucose ≥60 mg/dL;\n* Hemoglobin ≥6 g/dl or hematocrit ≥18% without signs of anemia-induced Congestive Heart Failure (CHF);\n* Negative urine pregnancy test for females ≥10 years of age (and of child bearing potential)\n\nExclusion Criteria:\n\n* Peripheral blood smear positive for mixed infection with multiple Plasmodium spp.\n* Severe or complicated malaria including subjects with any of the following:\n* Impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria;\n* Known hemoglobinuria;\n* Jaundice;\n* Respiratory distress;\n* Persistent vomiting;\n* Gross hematuria, as reported by the subject's legally acceptable representative;\n* Recent history of convulsions;\n* Inability to drink or breastfeed;\n* Unable to sit or stand as appropriate for age;\n* Known pregnancy or breast-feeding or positive urine pregnancy test (females ≥10 years of age and of child bearing potential);\n* History of allergy to or hypersensitivity to azithromycin, any macrolide, chloroquine, artemether, any artemisinin derivative, lumefantrine;\n* Any contraindication to any study drug including AZ, CQ and AL;\n* History of treatment with any antimalarial drug (such as halofantrine, chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment of a subject (and/or of the mother of a subject who is being breastfed) into the study;\n* Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the investigator would place the subject at increased risk to participate in the study."}, 'identificationModule': {'nctId': 'NCT00677833', 'briefTitle': 'Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa', 'orgStudyIdInfo': {'id': 'A0661157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Azithromycin plus Chloroquine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Artemether-lumefantrine']}], 'interventions': [{'name': 'Azithromycin plus Chloroquine', 'type': 'DRUG', 'description': 'Combination of Azithromycin plus Chloroquine Azithromycin (\\~30 mg/kg) + chloroquine (\\~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)', 'armGroupLabels': ['1']}, {'name': 'Artemether-lumefantrine', 'type': 'DRUG', 'description': 'Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nouna', 'country': 'Burkina Faso', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.72939, 'lon': -3.86305}}, {'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Navrongo', 'country': 'Ghana', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 10.89469, 'lon': -1.09083}}, {'zip': '40100', 'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Bamako', 'state': 'West Africa', 'country': 'Mali', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'city': 'Sikasso', 'state': 'West Africa', 'country': 'Mali', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 11.31755, 'lon': -5.66654}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}