Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-27 @ 1:03 PM
Study NCT ID:
NCT01256658
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2010-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'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'}, {'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic 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': {'phone': '41 61 324 1111', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety assessed throughout duration of study.', 'description': 'Safety assessments consisted of adverse events (AEs) and serious adverse events (SAEs) collection. AEs were collected during a period of 7 days from treatment administration start, for Asymptomatic Carriers and SMRCs only. SAEs were collected in both arms for the entire course of the study; hence the numbers in denominators are not consistent.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention - Period 1', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.', 'otherNumAtRisk': 4826, 'otherNumAffected': 0, 'seriousNumAtRisk': 4826, 'seriousNumAffected': 156}, {'id': 'EG001', 'title': 'Control - Period 1', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.', 'otherNumAtRisk': 2275, 'otherNumAffected': 0, 'seriousNumAtRisk': 2275, 'seriousNumAffected': 134}, {'id': 'EG002', 'title': 'Intervention - Period 2 - Follow-up Only', 'description': 'Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.', 'otherNumAtRisk': 467, 'otherNumAffected': 0, 'seriousNumAtRisk': 467, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Control - Period 2- Follow-up Only', 'description': 'Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.', 'otherNumAtRisk': 386, 'otherNumAffected': 0, 'seriousNumAtRisk': 386, 'seriousNumAffected': 39}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEART DISEASE CONGENITAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SICKLE CELL ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SICKLE CELL ANAEMIA WITH CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'CONJUNCTIVAL PALLOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'EYELID OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN LOWER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FOOD POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INGUINAL HERNIA STRANGULATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'LIP OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PEPTIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'SUDDEN DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BACTERIAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BREAST ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'EXTRAPULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTROENTERITIS SHIGELLA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEPATIC AMOEBIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HIV INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYDROCELE MALE INFECTED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFECTION PARASITIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MALARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MENINGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'OESOPHAGEAL CANDIDIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ORCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'PARASITIC GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4826, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2275, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 467, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 386, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1255', 'groupId': 'OG000'}, {'value': '1235', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.69', 'spread': '0.436', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.526', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 of period 1', 'description': 'Data is presented "per cluster". Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (\\<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.\n\nNumber of SMRC5000: sum of all SMRC5000 for all infants and children (\\<5 years) in post CSC.\n\nPerson-year observed: sum of duration (in days) for all infants and children (\\<5 years) in post CSC present in study /365.25.\n\nNumber of SMRC5000 per person-year = number of SMRC5000/person-year observed.', 'unitOfMeasure': 'SMRC5000 per person-year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized infants and children (\\<5 years) for which CSCs 1, 2, and 3 were conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'PRIMARY', 'title': 'Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3523', 'groupId': 'OG000'}, {'value': '3207', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'Day 1 (n = 2387, 2116)', 'categories': [{'measurements': [{'value': '11.81', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '12.06', 'spread': '0.345', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n = 1136, 1091)', 'categories': [{'measurements': [{'value': '12.33', 'spread': '0.318', 'groupId': 'OG000'}, {'value': '11.86', 'spread': '0.373', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and day 28 of period 1', 'description': 'Data is presented "per cluster". Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), \\> 6 months of age, at day 1 and at day 28.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized, \\> 6 months of age participants for which CSC1 was conducted, data was available and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 - period 1', 'description': 'Data is presented "per cluster". Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically.', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2023', 'groupId': 'OG000'}, {'value': '815', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 - period 1', 'description': 'Data is presented "per cluster". Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter.', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1167', 'groupId': 'OG000'}, {'value': '1148', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1/Day 1 (n= 819, 827)', 'categories': [{'measurements': [{'value': '10.24', 'spread': '0.371', 'groupId': 'OG000'}, {'value': '10.04', 'spread': '0.476', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/Day 1 (n= 348,321)', 'categories': [{'measurements': [{'value': '10.99', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '11.13', 'spread': '0.360', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1', 'description': 'Data is presented "per cluster". Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (\\>6 months and \\<5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all infants and children (\\>6 months and \\<5 years) randomized participants for which CSCs 1 and 4 were conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6817', 'groupId': 'OG000'}, {'value': '7258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000'}, {'value': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months - period 1', 'description': 'Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.\n\nNumber of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.\n\nNumber of SMRC5000 per person-year = number of SMRC5000/person-year observed.', 'unitOfMeasure': 'SMRC5000 per person-year', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6817', 'groupId': 'OG000'}, {'value': '7258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'Hospitalizations', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Severe malaria episodes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months - period 1', 'description': 'Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyzable asymptomatic carriers set consisted of all consenting inhabitants from intervention clusters confirmed positive by RDT for P. falciparum asexual forms at any CSC or when migrating into the cluster, in the absence of clinical signs and symptoms who received at least one dose of COA566 to treat the diagnosed asymptomatic infection.'}, {'type': 'SECONDARY', 'title': 'Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1023', 'groupId': 'OG000'}, {'value': '1040', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'Hospitalizations', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Severe malaria episodes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months - period 1', 'description': 'Total number of participants (infants and children (\\> 6 months and \\< 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analyzable carriers set consisted of all infants and children (\\> 6 months and \\< 5 years)) from intervention clusters confirmed positive for P. falciparum asexual forms at any CSC or when migrating into the cluster, who in the absence of clinical signs and symptoms received at least one dose of COA566 for the diagnosed asymptomatic infection.'}, {'type': 'SECONDARY', 'title': 'Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4859', 'groupId': 'OG000'}, {'value': '3542', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1/ day 1 (n= 2428, 1153)', 'categories': [{'measurements': [{'value': '42.8', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '8.05', 'groupId': 'OG001'}]}]}, {'title': 'CSC2/ day 1 (n= 237, 833)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '4.94', 'groupId': 'OG001'}]}]}, {'title': 'CSC3/ day 1 (n= 171, 741)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '9.26', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/ day 1 (n= 2023, 815)', 'categories': [{'measurements': [{'value': '34.4', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '6.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.\n\nMean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category.', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized participants for which CSC 1, 2 3 and 4 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '878', 'groupId': 'OG000'}, {'value': '633', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1/Day 1 (n= 543, 246)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '4.54', 'groupId': 'OG001'}]}]}, {'title': 'CSC2/Day 1 (n= 33, 130)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.54', 'groupId': 'OG001'}]}]}, {'title': 'CSC3/Day 1 (n= 23, 144)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/Day 1 (n= 279, 113)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.\n\nMean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category.', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Eligible clusters set consisted of all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1023', 'groupId': 'OG000'}, {'value': '976', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '514', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}]}]}, {'title': 'Not evaluable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 (CSC4/day 1) - period 1', 'description': 'Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1/Day 1 (n=432 ; 179 )', 'categories': [{'measurements': [{'value': '9.78', 'spread': '1.763', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '1.707', 'groupId': 'OG001'}]}]}, {'title': 'CSC1/Day 28 (n=406 ; 174 )', 'categories': [{'measurements': [{'value': '10.95', 'spread': '1.543', 'groupId': 'OG000'}, {'value': '10.17', 'spread': '1.748', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and day 28 - period 1', 'description': 'Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (\\>6 Months and \\<5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all infants and children (\\>6 months and \\<5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '819', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1/Day 1 Severe', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CSC1/Day 1 Moderate', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'CSC1/Day 1 Mild', 'categories': [{'measurements': [{'value': '458', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'CSC1/Day 1 No symptoms', 'categories': [{'measurements': [{'value': '278', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (CSC1/day 1) - period 1', 'description': 'Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (\\>6 months and \\<5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all infants and children (\\>6 months and \\<5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC4/Day 1 Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/Day 1 Moderate', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/Day 1 Mild', 'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'CSC4/Day 1 No', 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 (CSC4/day 1) - period 1', 'description': 'Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (\\>6 months and \\<5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all infants and children (\\>6 months and \\<5 years) randomized for which CSC4 was conducted, data was available, and census data was obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4677', 'groupId': 'OG000'}, {'value': '2090', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'CSC1 5- 9 years (n= 899, 431)', 'categories': [{'measurements': [{'value': '11.63', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '11.59', 'spread': '0.239', 'groupId': 'OG001'}]}]}, {'title': 'CSC4 5 - 9 years (n= 900, 396)', 'categories': [{'measurements': [{'value': '11.97', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '12.13', 'spread': '0.324', 'groupId': 'OG001'}]}]}, {'title': 'CSC1 10 - 14 years (n= 873, 380)', 'categories': [{'measurements': [{'value': '12.32', 'spread': '0.227', 'groupId': 'OG000'}, {'value': '12.71', 'spread': '0.301', 'groupId': 'OG001'}]}]}, {'title': 'CSC4 10 - 14 years (n= 837, 359)', 'categories': [{'measurements': [{'value': '12.58', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '12.72', 'spread': '0.487', 'groupId': 'OG001'}]}]}, {'title': 'CSC1 >= 15 years (n= 2904, 1279)', 'categories': [{'measurements': [{'value': '13.13', 'spread': '0.304', 'groupId': 'OG000'}, {'value': '13.49', 'spread': '0.355', 'groupId': 'OG001'}]}]}, {'title': 'CSC4 >= 15 years (n= 2760, 1136)', 'categories': [{'measurements': [{'value': '13.25', 'spread': '0.167', 'groupId': 'OG000'}, {'value': '13.42', 'spread': '0.266', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1', 'description': 'Data is presented "per cluster". Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all randomized participants (ages 5-9 years, 10-14 years, and ≥15 years) clusters for which CSC1 and CSC4 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2450', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Not applicable to this outcome measure'}], 'classes': [{'title': 'CSC1 (n= 2151)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}, {'title': 'CSC2 (n=182)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'CSC3 (n=117)', 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 of CSC1, CSC2 and CSC3 - period 1', 'description': 'Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3970', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Not applicable to this outcome measure'}], 'classes': [{'title': 'CSC1 Day 1 (n= 3045)', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}]}]}, {'title': 'CSC 1 Day 7 (n= 3045)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'CSC 1 Day 28 (n= 3045)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'CSC2 Day 1 (n= 850)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'CSC2 Day 7 (n= 850)', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'CSC3 Day 1 (n= 75)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'CSC3 Day 7 (n= 75)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, day 7 and day 28 - period 1', 'description': 'Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.'}, {'type': 'SECONDARY', 'title': 'Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 28- period 1', 'description': 'Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (\\>6 months and \\<5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all infants and children (\\>6 months and \\<5 years) randomized for which CSC1 was conducted, data was available, and census data was obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '43.2', 'spread': '12.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to day 28 - period 1', 'description': 'Data is presented "per cluster". Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (\\>6 months and \\<5 years) was measured by Hemoglobin levels based on microscopy reading.\n\nMean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category.', 'unitOfMeasure': 'participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all infants and children (\\>6 months and \\<5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '1381', 'groupId': 'OG001'}]}, {'units': 'number of units', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': '1 SMRC5000', 'categories': [{'measurements': [{'value': '15.25', 'spread': '3.531', 'groupId': 'OG000'}, {'value': '9.49', 'spread': '3.123', 'groupId': 'OG001'}]}]}, {'title': '2 SMRC5000', 'categories': [{'measurements': [{'value': '3.56', 'spread': '1.258', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '1.759', 'groupId': 'OG001'}]}]}, {'title': '3 SMRC5000', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.693', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.934', 'groupId': 'OG001'}]}]}, {'title': '>3 SMRC5000', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.664', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.417', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of units', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The number of units represents the number of clusters that include all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) were collected and census data were obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2740', 'groupId': 'OG000'}, {'value': '1381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': '1 SMRC5000', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': '2 SMRC5000', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': '3 SMRC5000', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '>3 SMRC5000', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months - period 1', 'description': 'Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and \\>3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible clusters set defined as all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and census data was obtained as per protocol.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2397', 'groupId': 'OG000'}, {'value': '1138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'classes': [{'title': 'Week (1-2) n at risk= 2397, 1138', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week (3-4) n at risk= 2396, 1133', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week (5-6) n at risk= 2391, 1129', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week (7-8) n at risk= 2390, 1124', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week (9-10) n at risk= 2390, 1123', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week (11-12) n at risk= 2390, 1121', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week (13-14) n at risk= 2390, 1103', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week (15-16) n at risk= 2390, 1102', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week (17-18) n at risk= 2390, 1102', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week (19-20) n at risk= 2390, 1102', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week (21-22) n at risk= 2337, 1083', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week (23-24) n at risk= 2311, 1077', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week (25-26) n at risk= 2246, 1063', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Week (27-28) n at risk= 2148, 1041', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Week (29-30) n at risk= 2047, 1020', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Week (31-32) n at risk= 1979, 996', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Week (33-34) n at risk= 1931, 979', 'categories': [{'measurements': [{'value': '421', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Week (35-36) n at risk= 1894, 968', 'categories': [{'measurements': [{'value': '440', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Week (37-38) n at risk= 1868, 956', 'categories': [{'measurements': [{'value': '460', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Week (39-40) n at risk= 1837, 935', 'categories': [{'measurements': [{'value': '477', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}, {'title': 'Week (41-42) n at risk= 1816, 927', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Week (43-44) n at risk= 1805, 920', 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Week (45-46) n at risk= 1785, 913', 'categories': [{'measurements': [{'value': '490', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Week (47-48) n at risk= 1773, 910', 'categories': [{'measurements': [{'value': '492', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}, {'title': 'Week (49-50) n at risk= 1758, 904', 'categories': [{'measurements': [{'value': '493', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 to Week 50', 'description': 'Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density \\> or = 5000/uL by microscopy.\n\nWeek (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individual subject data from eligible randomized participants from Community Screening Campaign 1 (CSC1) for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and available form analysis and census data was obtained as per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6817'}, {'groupId': 'FG001', 'numSubjects': '7258'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5897'}, {'groupId': 'FG001', 'numSubjects': '6510'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '920'}, {'groupId': 'FG001', 'numSubjects': '748'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '837'}, {'groupId': 'FG001', 'numSubjects': '661'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '44'}]}]}, {'title': 'Period 2 - Follow up Only - No Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '43 participants who completed period 1 did not enroll to continue on period 2', 'groupId': 'FG000', 'numSubjects': '5854'}, {'comment': '138 participants who completed period 1 did not enroll to continue on period 2', 'groupId': 'FG001', 'numSubjects': '6372'}]}, {'type': 'Lost to Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Death', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Study Termination', 'achievements': [{'comment': '43 participants who completed period 1 did not enroll to continue on period 2', 'groupId': 'FG000', 'numSubjects': '5777'}, {'comment': '138 participants who completed period 1 did not enroll to continue on period 2', 'groupId': 'FG001', 'numSubjects': '6287'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5854'}, {'groupId': 'FG001', 'numSubjects': '6372'}]}]}], 'recruitmentDetails': 'This was an 18 clusters randomized study (1 cluster = 1 village). 14,075 participants were recruited during Period 1 (treatment); of these, 12,226 participants continued onto Period 2 (1 year follow-up) to assess longer term impact of initial intervention on malaria episodes. Period 2 was stopped and all participants discontinued.', 'preAssignmentDetails': 'During period 1 clusters were randomized 1:1 to either the control or the intervention arm (9 clusters per arm). In the intervention arm subjects were screened for asymptomatic carriage of P. falciparum status and treated with COA566. In both arms, subjects were treated for symptomatic malaria episodes. During period 2 there was no study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6817', 'groupId': 'BG000'}, {'value': '7258', 'groupId': 'BG001'}, {'value': '14075', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.02', 'spread': '20.67', 'groupId': 'BG000'}, {'value': '22.62', 'spread': '20.31', 'groupId': 'BG001'}, {'value': '22.82', 'spread': '20.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3656', 'groupId': 'BG000'}, {'value': '3816', 'groupId': 'BG001'}, {'value': '7472', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3161', 'groupId': 'BG000'}, {'value': '3442', 'groupId': 'BG001'}, {'value': '6603', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14075}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2010-12-06', 'resultsFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-22', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)', 'timeFrame': 'Month 12 of period 1', 'description': 'Data is presented "per cluster". Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (\\<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.\n\nNumber of SMRC5000: sum of all SMRC5000 for all infants and children (\\<5 years) in post CSC.\n\nPerson-year observed: sum of duration (in days) for all infants and children (\\<5 years) in post CSC present in study /365.25.\n\nNumber of SMRC5000 per person-year = number of SMRC5000/person-year observed.'}, {'measure': 'Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)', 'timeFrame': 'Day 1 and day 28 of period 1', 'description': 'Data is presented "per cluster". Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), \\> 6 months of age, at day 1 and at day 28.'}], 'secondaryOutcomes': [{'measure': 'Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)', 'timeFrame': 'Month 12 - period 1', 'description': 'Data is presented "per cluster". Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically.'}, {'measure': 'Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)', 'timeFrame': 'Month 12 - period 1', 'description': 'Data is presented "per cluster". Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter.'}, {'measure': 'Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)', 'timeFrame': 'Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1', 'description': 'Data is presented "per cluster". Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (\\>6 months and \\<5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant.'}, {'measure': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)', 'timeFrame': '12 months - period 1', 'description': 'Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.\n\nNumber of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.\n\nNumber of SMRC5000 per person-year = number of SMRC5000/person-year observed.'}, {'measure': 'Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)', 'timeFrame': '12 months - period 1', 'description': 'Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.'}, {'measure': 'Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)', 'timeFrame': '12 months - period 1', 'description': 'Total number of participants (infants and children (\\> 6 months and \\< 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.'}, {'measure': 'Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.\n\nMean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category.'}, {'measure': 'Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.\n\nMean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category.'}, {'measure': 'Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)', 'timeFrame': 'Month 12 (CSC4/day 1) - period 1', 'description': 'Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.'}, {'measure': 'Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1', 'timeFrame': 'Day 1 and day 28 - period 1', 'description': 'Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (\\>6 Months and \\<5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).'}, {'measure': 'Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)', 'timeFrame': 'Day 1 (CSC1/day 1) - period 1', 'description': 'Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (\\>6 months and \\<5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).'}, {'measure': 'Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)', 'timeFrame': 'Month 12 (CSC4/day 1) - period 1', 'description': 'Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (\\>6 months and \\<5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) \\<5 g/dL = severe anemia, Hb 5 to \\<8 g/dL = moderate anemia, Hb 8 to \\<11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).'}, {'measure': 'Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)', 'timeFrame': 'Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1', 'description': 'Data is presented "per cluster". Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant.'}, {'measure': 'Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7', 'timeFrame': 'Day 7 of CSC1, CSC2 and CSC3 - period 1', 'description': 'Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.'}, {'measure': 'Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers', 'timeFrame': 'Day 1, day 7 and day 28 - period 1', 'description': 'Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).'}, {'measure': 'Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data', 'timeFrame': 'Day 1 to Day 28- period 1', 'description': 'Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (\\>6 months and \\<5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.'}, {'measure': 'Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data', 'timeFrame': 'Day 1 to day 28 - period 1', 'description': 'Data is presented "per cluster". Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (\\>6 months and \\<5 years) was measured by Hemoglobin levels based on microscopy reading.\n\nMean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category.'}, {'measure': 'Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)', 'timeFrame': '12 months - period 1', 'description': 'Data is presented "per cluster". Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.'}, {'measure': 'Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined', 'timeFrame': '12 months - period 1', 'description': 'Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and \\>3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.'}, {'measure': 'Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50', 'timeFrame': 'Week 1 to Week 50', 'description': 'Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density \\> or = 5000/uL by microscopy.\n\nWeek (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['P. falciparum', 'malaria', 'asymptomatic carriers', 'bed-nets', 'ITN-insecticide-treated net', 'idiopathic trigeminal neuralgia', 'RDT-Rapid diagnostic test'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '20096111', 'type': 'BACKGROUND', 'citation': 'Ogutu B, Tiono AB, Makanga M, Premji Z, Gbadoe AD, Ubben D, Marrast AC, Gaye O. Treatment of asymptomatic carriers with artemether-lumefantrine: an opportunity to reduce the burden of malaria? Malar J. 2010 Jan 22;9:30. doi: 10.1186/1475-2875-9-30.'}, {'pmid': '24215306', 'type': 'DERIVED', 'citation': 'Tiono AB, Guelbeogo MW, Sagnon NF, Nebie I, Sirima SB, Mukhopadhyay A, Hamed K. Dynamics of malaria transmission and susceptibility to clinical malaria episodes following treatment of Plasmodium falciparum asymptomatic carriers: results of a cluster-randomized study of community-wide screening and treatment, and a parallel entomology study. BMC Infect Dis. 2013 Nov 12;13:535. doi: 10.1186/1471-2334-13-535.'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on a number of clinical malaria cases in children less than 5 years of age and the improvement of hemoglobin levels in the overall population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).\n* Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)\n\nExclusion:\n\n* Body weight \\<5 kg.\n* Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.\n* Presence of severe malaria signs and symptoms\n* First trimester of pregnancy.\n* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.\n* Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.\n* Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.\n* Taking drugs which may be metabolized by cytochrome enzyme CYP2D6'}, 'identificationModule': {'nctId': 'NCT01256658', 'briefTitle': 'A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Cluster Randomized, Single-centre, Controlled, Parallel,12-month Prospective Study and Additional 12-month Follow-up in Africa of Malaria Incidence in a Community Setting Following Systematic Treatment of P. Falciparum Asymptomatic Carriers With Artemether-lumefantrine (Coartem® / Coartem® Dispersible)', 'orgStudyIdInfo': {'id': 'CCOA566B2401'}, 'secondaryIdInfos': [{'id': 'CCOA566B2401E1', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.', 'interventionNames': ['Drug: COA566']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Participants received COA566 treatment for symptomatic malaria episodes only.', 'interventionNames': ['Drug: COA566']}], 'interventions': [{'name': 'COA566', 'type': 'DRUG', 'otherNames': ['Artemether-lumefantrine'], 'description': 'COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ouagadougou', 'state': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Centre National de Recherche et de Formation sur le Paludisme', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Ouagadougou', 'state': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'zip': '2208', 'city': 'Burkina Faso', 'country': 'Burkina Faso', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}