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| ID | Type | Description | Link |
|---|---|---|---|
| CCOA566B2401E1 | Other Identifier | Novartis |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. |
|
| Control | Experimental | Participants received COA566 treatment for symptomatic malaria episodes only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COA566 | Drug | COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC. Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25. Number of SMRC5000 per person-year = number of SMRC5000/person-year observed. | Month 12 of period 1 |
| Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster) | 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. | Day 1 and day 28 of period 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster) | 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. | Month 12 - period 1 |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre National de Recherche et de Formation sur le Paludisme | Ouagadougou | Ouagadougou | Burkina Faso | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20096111 | Background | 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. | |
| 24215306 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. |
| FG001 | Control | Participants received COA566 treatment for symptomatic malaria episodes only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 - Follow up Only - No Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. |
| BG001 | Control | Participants received COA566 treatment for symptomatic malaria episodes only. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC. Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25. Number of SMRC5000 per person-year = number of SMRC5000/person-year observed. | 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. | Posted | Mean | Standard Deviation | SMRC5000 per person-year | Month 12 of period 1 | number of units | Participants |
Safety assessed throughout duration of study.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Period 1 | Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 41 61 324 1111 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster) | 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. | Month 12 - period 1 |
| Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster) | 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. | Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1 |
| Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC) | 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. Number 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. Number of SMRC5000 per person-year = number of SMRC5000/person-year observed. | 12 months - period 1 |
| Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) | Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed. | 12 months - period 1 |
| Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) | 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. | 12 months - period 1 |
| Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster) | 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. Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category. | 12 months - period 1 |
| 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) | 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. Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category. | 12 months - period 1 |
| Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) | 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. | Month 12 (CSC4/day 1) - period 1 |
| 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 | 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). | Day 1 and day 28 - period 1 |
| Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years) | 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). | Day 1 (CSC1/day 1) - period 1 |
| Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years) | 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). | Month 12 (CSC4/day 1) - period 1 |
| Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster) | 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. | Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1 |
| 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 | 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. | Day 7 of CSC1, CSC2 and CSC3 - period 1 |
| Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers | 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). | Day 1, day 7 and day 28 - period 1 |
| 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 | 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. | Day 1 to Day 28- period 1 |
| 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 | 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. Mean 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. | Day 1 to day 28 - period 1 |
| Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster) | 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. | 12 months - period 1 |
| Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined | 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. | 12 months - period 1 |
| Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50 | 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. Week (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. | Week 1 to Week 50 |
| Novartis Investigative site |
| Ouagadougou |
| Ouagadougou |
| Burkina Faso |
| Novartis Investigative Site | Burkina Faso | 2208 | Burkina Faso |
| Death |
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| Death |
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| Study Termination |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Intervention | Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. |
| OG001 | Control | Participants received COA566 treatment for symptomatic malaria episodes only. |
|
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| Primary | Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster) | 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. | 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. | Posted | Mean | Standard Deviation | g/dL | Day 1 and day 28 of period 1 | number of units | Participants |
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| Secondary | Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster) | 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. | 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. | Posted | Mean | Standard Error | participants | Month 12 - period 1 | number of units | Participants |
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| Secondary | Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster) | 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. | 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. | Posted | Mean | Standard Error | participants | Month 12 - period 1 | number of units | Participants |
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| Secondary | Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster) | 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. | 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. | Posted | Mean | Standard Deviation | g/dL | Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1 | number of units | Participants |
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| Secondary | Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC) | 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. Number 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. Number of SMRC5000 per person-year = number of SMRC5000/person-year observed. | 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. | Posted | Number | SMRC5000 per person-year | 12 months - period 1 |
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| Secondary | Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) | Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed. | 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. | Posted | Number | participants | 12 months - period 1 |
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| Secondary | Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC) | 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. | 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. | Posted | Number | participants | 12 months - period 1 |
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| Secondary | Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster) | 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. Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category. | 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. | Posted | Mean | Standard Deviation | participants | 12 months - period 1 | number of units | Participants |
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| Secondary | 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) | 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. Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category. | 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. | Posted | Mean | Standard Deviation | participants | 12 months - period 1 | number of units | Participants |
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| Secondary | Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) | 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. | 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. | Posted | Number | participants | Month 12 (CSC4/day 1) - period 1 |
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| Secondary | 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 | 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). | 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. | Posted | Mean | Standard Deviation | g/dL | Day 1 and day 28 - period 1 |
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| Secondary | Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years) | 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). | 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. | Posted | Number | participants | Day 1 (CSC1/day 1) - period 1 |
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| Secondary | Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years) | 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). | 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. | Posted | Number | participants | Month 12 (CSC4/day 1) - period 1 |
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|
|
| Secondary | Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster) | 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. | 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. | Posted | Mean | Standard Deviation | g/dL | Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1 | number of units | Participants |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | Day 7 of CSC1, CSC2 and CSC3 - period 1 |
|
|
|
| Secondary | Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers | 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). | 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. | Posted | Number | percentage of participants | Day 1, day 7 and day 28 - period 1 |
|
|
|
| Secondary | 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 | 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. | 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. | Posted | Number | participants | Day 1 to Day 28- period 1 |
|
|
|
| Secondary | 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 | 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. Mean 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. | 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. | Posted | Mean | Standard Deviation | participants | Day 1 to day 28 - period 1 | number of units | Participants |
|
|
|
| Secondary | Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster) | 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. | 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. | Posted | Mean | Standard Deviation | percentage of participants | 12 months - period 1 | number of units | Participants |
|
|
|
| Secondary | Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined | 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. | 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. | Posted | Number | participants | 12 months - period 1 |
|
|
|
| Secondary | Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50 | 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. Week (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. | 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. | Posted | Number | participants | Week 1 to Week 50 |
|
|
|
| 156 |
| 4,826 |
| 0 |
| 4,826 |
| EG001 | Control - Period 1 | Participants received COA566 treatment for symptomatic malaria episodes only. | 134 | 2,275 | 0 | 2,275 |
| EG002 | Intervention - Period 2 - Follow-up Only | 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. | 23 | 467 | 0 | 467 |
| EG003 | Control - Period 2- Follow-up Only | 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. | 39 | 386 | 0 | 386 |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| HEART DISEASE CONGENITAL | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| SICKLE CELL ANAEMIA | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| SICKLE CELL ANAEMIA WITH CRISIS | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| CONJUNCTIVAL PALLOR | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| EYELID OEDEMA | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| INGUINAL HERNIA STRANGULATED | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| LIP OEDEMA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| PEPTIC ULCER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| SUDDEN DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| JAUNDICE | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| BACTERIAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| BREAST ABSCESS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| EXTRAPULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| GASTROENTERITIS SHIGELLA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| HEPATIC AMOEBIASIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| HIV INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| HYDROCELE MALE INFECTED | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| INFECTION PARASITIC | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| MALARIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| MENINGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| OESOPHAGEAL CANDIDIASIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| ORCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| PARASITIC GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| PERITONEAL TUBERCULOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| TUBERCULOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| TYPHOID FEVER | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| CHEMICAL POISONING | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| SNAKE BITE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| WOUND | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| BLADDER NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| COMA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| CONVULSION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| EPILEPSY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| ABORTION THREATENED | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| CERVIX DYSTOCIA | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| COMPLICATION OF DELIVERY | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| FOETAL DISTRESS SYNDROME | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| FOETAL MALPRESENTATION | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| POLYHYDRAMNIOS | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| STILLBIRTH | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| THIRD STAGE POSTPARTUM HAEMORRHAGE | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| UTERINE CERVICAL LACERATION DURING LABOUR | Pregnancy, puerperium and perinatal conditions | MedDRA 15.1 | Systematic Assessment |
|
| AFFECTIVE DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| PERSONALITY CHANGE | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| RENAL COLIC | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| URINARY TRACT DISORDER | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| EPIDIDYMITIS | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| TESTICULAR TORSION | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ASTHMATIC CRISIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| BRONCHOPNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| D000079426 |
| Vector Borne Diseases |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Death |
|
| Death |
|
| CSC3/ day 1 (n= 171, 741) |
|
| CSC4/ day 1 (n= 2023, 815) |
|
| CSC3/Day 1 (n= 23, 144) |
|
| CSC4/Day 1 (n= 279, 113) |
|
| Not evaluable |
|
| CSC1/Day 1 Mild |
|
| CSC1/Day 1 No symptoms |
|
| CSC4/Day 1 Mild |
|
| CSC4/Day 1 No |
|
| CSC1 10 - 14 years (n= 873, 380) |
|
| CSC4 10 - 14 years (n= 837, 359) |
|
| CSC1 >= 15 years (n= 2904, 1279) |
|
| CSC4 >= 15 years (n= 2760, 1136) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| CSC2 Day 1 (n= 850) |
|
| CSC2 Day 7 (n= 850) |
|
| CSC3 Day 1 (n= 75) |
|
| CSC3 Day 7 (n= 75) |
|
| 3 SMRC5000 |
|
| >3 SMRC5000 |
|
| 3 SMRC5000 |
|
| >3 SMRC5000 |
|
| Week (5-6) n at risk= 2391, 1129 |
|
| Week (7-8) n at risk= 2390, 1124 |
|
| Week (9-10) n at risk= 2390, 1123 |
|
| Week (11-12) n at risk= 2390, 1121 |
|
| Week (13-14) n at risk= 2390, 1103 |
|
| Week (15-16) n at risk= 2390, 1102 |
|
| Week (17-18) n at risk= 2390, 1102 |
|
| Week (19-20) n at risk= 2390, 1102 |
|
| Week (21-22) n at risk= 2337, 1083 |
|
| Week (23-24) n at risk= 2311, 1077 |
|
| Week (25-26) n at risk= 2246, 1063 |
|
| Week (27-28) n at risk= 2148, 1041 |
|
| Week (29-30) n at risk= 2047, 1020 |
|
| Week (31-32) n at risk= 1979, 996 |
|
| Week (33-34) n at risk= 1931, 979 |
|
| Week (35-36) n at risk= 1894, 968 |
|
| Week (37-38) n at risk= 1868, 956 |
|
| Week (39-40) n at risk= 1837, 935 |
|
| Week (41-42) n at risk= 1816, 927 |
|
| Week (43-44) n at risk= 1805, 920 |
|
| Week (45-46) n at risk= 1785, 913 |
|
| Week (47-48) n at risk= 1773, 910 |
|
| Week (49-50) n at risk= 1758, 904 |
|