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A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)

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ClinicalTrials.gov Identifier: NCT01256658
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : November 25, 2013
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malaria
Intervention Drug: COA566
Enrollment 14075
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Intervention Control
Hide Arm/Group Description Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. Participants received COA566 treatment for symptomatic malaria episodes only.
Period Title: Period 1
Started 6817 7258
Completed 5897 6510
Not Completed 920 748
Reason Not Completed
Lost to Follow-up             837             661
Withdrawal by Subject             35             43
Death             48             44
Period Title: Period 2 - Follow up Only - No Treatment
Started 5854 [1] 6372 [2]
Lost to Follow up 71 77
Death 6 8
Study Termination 5777 [1] 6287 [2]
Completed 0 0
Not Completed 5854 6372
[1]
43 participants who completed period 1 did not enroll to continue on period 2
[2]
138 participants who completed period 1 did not enroll to continue on period 2
Arm/Group Title Intervention Control Total
Hide Arm/Group Description Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. Participants received COA566 treatment for symptomatic malaria episodes only. Total of all reporting groups
Overall Number of Baseline Participants 6817 7258 14075
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6817 participants 7258 participants 14075 participants
23.02  (20.67) 22.62  (20.31) 22.82  (20.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6817 participants 7258 participants 14075 participants
Female
3656
  53.6%
3816
  52.6%
7472
  53.1%
Male
3161
  46.4%
3442
  47.4%
6603
  46.9%
1.Primary Outcome
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)
Hide 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.

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.

Time Frame Month 12 of period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 1255 1235
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: SMRC5000 per person-year
1.69  (0.436) 1.60  (0.526)
2.Primary Outcome
Title Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)
Hide 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.
Time Frame Day 1 and day 28 of period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 3523 3207
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: g/dL
Day 1 (n = 2387, 2116) 11.81  (0.329) 12.06  (0.345)
Day 28 (n = 1136, 1091) 12.33  (0.318) 11.86  (0.373)
3.Secondary Outcome
Title Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)
Hide 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.
Time Frame Month 12 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 297 113
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Error)
Unit of Measure: participants
4.9  (0.41) 5.1  (0.41)
4.Secondary Outcome
Title Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)
Hide 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.
Time Frame Month 12 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 2023 815
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Error)
Unit of Measure: participants
34.6  (1.86) 37.6  (1.86)
5.Secondary Outcome
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)
Hide 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.
Time Frame Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 1167 1148
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: g/dL
CSC1/Day 1 (n= 819, 827) 10.24  (0.371) 10.04  (0.476)
CSC4/Day 1 (n= 348,321) 10.99  (0.267) 11.13  (0.360)
6.Secondary Outcome
Title Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)
Hide 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.

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.

Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 6817 7258
Measure Type: Number
Unit of Measure: SMRC5000 per person-year
0.45 0.39
7.Secondary Outcome
Title Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)
Hide Description Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.
Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 6817 7258
Measure Type: Number
Unit of Measure: participants
Hospitalizations 68 57
Severe malaria episodes 10 9
Death 31 31
8.Secondary Outcome
Title Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)
Hide 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.
Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 1023 1040
Measure Type: Number
Unit of Measure: participants
Hospitalizations 20 21
Severe malaria episodes 4 5
Death 2 2
9.Secondary Outcome
Title Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)
Hide 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.

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.

Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 4859 3542
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: participants
CSC1/ day 1 (n= 2428, 1153) 42.8  (5.67) 47.5  (8.05)
CSC2/ day 1 (n= 237, 833) 4.1  (1.62) 35.7  (4.94)
CSC3/ day 1 (n= 171, 741) 2.8  (0.92) 32.2  (9.26)
CSC4/ day 1 (n= 2023, 815) 34.4  (3.92) 37.8  (6.37)
10.Secondary Outcome
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)
Hide 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.

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.

Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 878 633
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: participants
CSC1/Day 1 (n= 543, 246) 9.5  (2.95) 10.2  (4.54)
CSC2/Day 1 (n= 33, 130) 0.6  (0.38) 5.5  (2.54)
CSC3/Day 1 (n= 23, 144) 0.4  (0.40) 5.8  (1.77)
CSC4/Day 1 (n= 279, 113) 4.8  (1.34) 5.1  (1.38)
11.Secondary Outcome
Title Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)
Hide 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.
Time Frame Month 12 (CSC4/day 1) - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 1023 976
Measure Type: Number
Unit of Measure: participants
Positive 508 462
Negative 514 511
Not evaluable 1 3
12.Secondary Outcome
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
Hide 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).
Time Frame Day 1 and day 28 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 432 179
Mean (Standard Deviation)
Unit of Measure: g/dL
CSC1/Day 1 (n=432 ; 179 ) 9.78  (1.763) 9.67  (1.707)
CSC1/Day 28 (n=406 ; 174 ) 10.95  (1.543) 10.17  (1.748)
13.Secondary Outcome
Title Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)
Hide 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).
Time Frame Day 1 (CSC1/day 1) - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 819 348
Measure Type: Number
Unit of Measure: participants
CSC1/Day 1 Severe 3 1
CSC1/Day 1 Moderate 80 36
CSC1/Day 1 Mild 458 195
CSC1/Day 1 No symptoms 278 116
14.Secondary Outcome
Title Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)
Hide 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).
Time Frame Month 12 (CSC4/day 1) - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 827 321
Measure Type: Number
Unit of Measure: participants
CSC4/Day 1 Severe 1 1
CSC4/Day 1 Moderate 29 9
CSC4/Day 1 Mild 349 117
CSC4/Day 1 No 448 194
15.Secondary Outcome
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)
Hide 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.
Time Frame Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 4677 2090
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: g/dL
CSC1 5- 9 years (n= 899, 431) 11.63  (0.223) 11.59  (0.239)
CSC4 5 - 9 years (n= 900, 396) 11.97  (0.224) 12.13  (0.324)
CSC1 10 - 14 years (n= 873, 380) 12.32  (0.227) 12.71  (0.301)
CSC4 10 - 14 years (n= 837, 359) 12.58  (0.161) 12.72  (0.487)
CSC1 >= 15 years (n= 2904, 1279) 13.13  (0.304) 13.49  (0.355)
CSC4 >= 15 years (n= 2760, 1136) 13.25  (0.167) 13.42  (0.266)
16.Secondary Outcome
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
Hide 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.
Time Frame Day 7 of CSC1, CSC2 and CSC3 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Not applicable to this outcome measure
Overall Number of Participants Analyzed 2450 0
Measure Type: Number
Unit of Measure: percentage of participants
CSC1 (n= 2151) 99.5
CSC2 (n=182) 100
CSC3 (n=117) 96.7
17.Secondary Outcome
Title Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers
Hide 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).
Time Frame Day 1, day 7 and day 28 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Not applicable to this outcome measure
Overall Number of Participants Analyzed 3970 0
Measure Type: Number
Unit of Measure: percentage of participants
CSC1 Day 1 (n= 3045) 15.7
CSC 1 Day 7 (n= 3045) 1.4
CSC 1 Day 28 (n= 3045) 0.1
CSC2 Day 1 (n= 850) 2.6
CSC2 Day 7 (n= 850) 0.1
CSC3 Day 1 (n= 75) 4.0
CSC3 Day 7 (n= 75) 0
18.Secondary Outcome
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
Hide 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.
Time Frame Day 1 to Day 28- period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 434 180
Measure Type: Number
Unit of Measure: participants
288 79
19.Secondary Outcome
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
Hide 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.

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.

Time Frame Day 1 to day 28 - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 434 180
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: participants
66.1  (9.17) 43.2  (12.45)
20.Secondary Outcome
Title Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)
Hide 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.
Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 2740 1381
Overall Number of Units Analyzed
Type of Units Analyzed: Number of units
9 9
Mean (Standard Deviation)
Unit of Measure: percentage of participants
1 SMRC5000 15.25  (3.531) 9.49  (3.123)
2 SMRC5000 3.56  (1.258) 2.78  (1.759)
3 SMRC5000 1.28  (0.693) 0.97  (0.934)
>3 SMRC5000 0.67  (0.664) 0.31  (0.417)
21.Secondary Outcome
Title Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined
Hide 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.
Time Frame 12 months - period 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 2740 1381
Measure Type: Number
Unit of Measure: participants
1 SMRC5000 413 136
2 SMRC5000 96 38
3 SMRC5000 34 12
>3 SMRC5000 17 5
22.Secondary Outcome
Title Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50
Hide 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.

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.

Time Frame Week 1 to Week 50
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Participants received COA566 treatment for symptomatic malaria episodes only.
Overall Number of Participants Analyzed 2397 1138
Measure Type: Number
Unit of Measure: participants
Week (1-2) n at risk= 2397, 1138 1 4
Week (3-4) n at risk= 2396, 1133 3 8
Week (5-6) n at risk= 2391, 1129 4 12
Week (7-8) n at risk= 2390, 1124 4 13
Week (9-10) n at risk= 2390, 1123 4 15
Week (11-12) n at risk= 2390, 1121 4 17
Week (13-14) n at risk= 2390, 1103 4 18
Week (15-16) n at risk= 2390, 1102 4 18
Week (17-18) n at risk= 2390, 1102 4 18
Week (19-20) n at risk= 2390, 1102 7 20
Week (21-22) n at risk= 2337, 1083 30 24
Week (23-24) n at risk= 2311, 1077 92 38
Week (25-26) n at risk= 2246, 1063 188 59
Week (27-28) n at risk= 2148, 1041 287 79
Week (29-30) n at risk= 2047, 1020 347 98
Week (31-32) n at risk= 1979, 996 391 114
Week (33-34) n at risk= 1931, 979 421 121
Week (35-36) n at risk= 1894, 968 440 130
Week (37-38) n at risk= 1868, 956 460 144
Week (39-40) n at risk= 1837, 935 477 149
Week (41-42) n at risk= 1816, 927 483 154
Week (43-44) n at risk= 1805, 920 486 158
Week (45-46) n at risk= 1785, 913 490 159
Week (47-48) n at risk= 1773, 910 492 161
Week (49-50) n at risk= 1758, 904 493 161
Time Frame Safety assessed throughout duration of study.
Adverse Event Reporting 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.
 
Arm/Group Title Intervention - Period 1 Control - Period 1 Intervention - Period 2 - Follow-up Only Control - Period 2- Follow-up Only
Hide Arm/Group Description Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes. Participants received COA566 treatment for symptomatic malaria episodes 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. 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.
All-Cause Mortality
Intervention - Period 1 Control - Period 1 Intervention - Period 2 - Follow-up Only Control - Period 2- Follow-up Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention - Period 1 Control - Period 1 Intervention - Period 2 - Follow-up Only Control - Period 2- Follow-up Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   156/4826 (3.23%)   134/2275 (5.89%)   23/467 (4.93%)   39/386 (10.10%) 
Blood and lymphatic system disorders         
ANAEMIA  1  1/4826 (0.02%)  1/2275 (0.04%)  1/467 (0.21%)  2/386 (0.52%) 
Cardiac disorders         
CARDIAC FAILURE  1  2/4826 (0.04%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
Congenital, familial and genetic disorders         
HEART DISEASE CONGENITAL  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
SICKLE CELL ANAEMIA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
SICKLE CELL ANAEMIA WITH CRISIS  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Eye disorders         
CONJUNCTIVAL PALLOR  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
EYELID OEDEMA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Gastrointestinal disorders         
ABDOMINAL HERNIA  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
ABDOMINAL PAIN  1  5/4826 (0.10%)  4/2275 (0.18%)  0/467 (0.00%)  2/386 (0.52%) 
ABDOMINAL PAIN LOWER  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
ABDOMINAL PAIN UPPER  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
DIARRHOEA  1  2/4826 (0.04%)  1/2275 (0.04%)  1/467 (0.21%)  2/386 (0.52%) 
FOOD POISONING  1  3/4826 (0.06%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
GASTROINTESTINAL HAEMORRHAGE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
INGUINAL HERNIA  1  1/4826 (0.02%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
INGUINAL HERNIA STRANGULATED  1  2/4826 (0.04%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
INTESTINAL OBSTRUCTION  1  0/4826 (0.00%)  1/2275 (0.04%)  1/467 (0.21%)  0/386 (0.00%) 
LIP OEDEMA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
NAUSEA  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
PEPTIC ULCER  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
VOMITING  1  14/4826 (0.29%)  16/2275 (0.70%)  1/467 (0.21%)  1/386 (0.26%) 
General disorders         
ASTHENIA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
DEATH  1  11/4826 (0.23%)  13/2275 (0.57%)  2/467 (0.43%)  1/386 (0.26%) 
PYREXIA  1  5/4826 (0.10%)  4/2275 (0.18%)  3/467 (0.64%)  0/386 (0.00%) 
SUDDEN DEATH  1  2/4826 (0.04%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Hepatobiliary disorders         
JAUNDICE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Infections and infestations         
APPENDICITIS  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
BACTERIAL INFECTION  1  4/4826 (0.08%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
BREAST ABSCESS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
BRONCHITIS  1  3/4826 (0.06%)  2/2275 (0.09%)  0/467 (0.00%)  1/386 (0.26%) 
EXTRAPULMONARY TUBERCULOSIS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
GASTROENTERITIS  1  7/4826 (0.15%)  5/2275 (0.22%)  1/467 (0.21%)  0/386 (0.00%) 
GASTROENTERITIS SHIGELLA  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
HEPATIC AMOEBIASIS  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
HIV INFECTION  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
HYDROCELE MALE INFECTED  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
INFECTION  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
INFECTION PARASITIC  1  0/4826 (0.00%)  1/2275 (0.04%)  2/467 (0.43%)  0/386 (0.00%) 
MALARIA  1  42/4826 (0.87%)  39/2275 (1.71%)  9/467 (1.93%)  8/386 (2.07%) 
MENINGITIS  1  1/4826 (0.02%)  4/2275 (0.18%)  0/467 (0.00%)  1/386 (0.26%) 
OESOPHAGEAL CANDIDIASIS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
ORCHITIS  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
PARASITIC GASTROENTERITIS  1  1/4826 (0.02%)  2/2275 (0.09%)  0/467 (0.00%)  0/386 (0.00%) 
PERITONEAL TUBERCULOSIS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
PNEUMONIA  1  28/4826 (0.58%)  23/2275 (1.01%)  3/467 (0.64%)  7/386 (1.81%) 
RESPIRATORY TRACT INFECTION  1  2/4826 (0.04%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
SEPSIS  1  1/4826 (0.02%)  2/2275 (0.09%)  0/467 (0.00%)  1/386 (0.26%) 
TUBERCULOSIS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
TYPHOID FEVER  1  2/4826 (0.04%)  6/2275 (0.26%)  1/467 (0.21%)  1/386 (0.26%) 
Injury, poisoning and procedural complications         
CHEMICAL POISONING  1  0/4826 (0.00%)  2/2275 (0.09%)  0/467 (0.00%)  0/386 (0.00%) 
FEMUR FRACTURE  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
HEAD INJURY  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
LOWER LIMB FRACTURE  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
PELVIC FRACTURE  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
RIB FRACTURE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  2/4826 (0.04%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
SNAKE BITE  1  3/4826 (0.06%)  2/2275 (0.09%)  1/467 (0.21%)  0/386 (0.00%) 
TOXICITY TO VARIOUS AGENTS  1  1/4826 (0.02%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
WOUND  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
MALNUTRITION  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Musculoskeletal and connective tissue disorders         
INTERVERTEBRAL DISC DEGENERATION  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BLADDER NEOPLASM  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Nervous system disorders         
COMA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
CONVULSION  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
DIZZINESS  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
EPILEPSY  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
HEADACHE  1  2/4826 (0.04%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
LOSS OF CONSCIOUSNESS  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
NERVOUS SYSTEM DISORDER  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
SOMNOLENCE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
ABORTION SPONTANEOUS  1  2/4826 (0.04%)  3/2275 (0.13%)  1/467 (0.21%)  2/386 (0.52%) 
ABORTION THREATENED  1  1/4826 (0.02%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
CERVIX DYSTOCIA  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
COMPLICATION OF DELIVERY  1  3/4826 (0.06%)  2/2275 (0.09%)  1/467 (0.21%)  1/386 (0.26%) 
ECTOPIC PREGNANCY  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
FOETAL DISTRESS SYNDROME  1  1/4826 (0.02%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
FOETAL MALPRESENTATION  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
POLYHYDRAMNIOS  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
STILLBIRTH  1  2/4826 (0.04%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
THIRD STAGE POSTPARTUM HAEMORRHAGE  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
UTERINE CERVICAL LACERATION DURING LABOUR  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Psychiatric disorders         
AFFECTIVE DISORDER  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
COMPLETED SUICIDE  1  2/4826 (0.04%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
PERSONALITY CHANGE  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Renal and urinary disorders         
NEPHROTIC SYNDROME  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
RENAL COLIC  1  2/4826 (0.04%)  3/2275 (0.13%)  0/467 (0.00%)  0/386 (0.00%) 
RENAL FAILURE  1  4/4826 (0.08%)  3/2275 (0.13%)  0/467 (0.00%)  0/386 (0.00%) 
URINARY TRACT DISORDER  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Reproductive system and breast disorders         
EPIDIDYMITIS  1  0/4826 (0.00%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
TESTICULAR TORSION  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
ASTHMA  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
ASTHMATIC CRISIS  1  1/4826 (0.02%)  1/2275 (0.04%)  0/467 (0.00%)  1/386 (0.26%) 
BRONCHOPNEUMOPATHY  1  0/4826 (0.00%)  0/2275 (0.00%)  1/467 (0.21%)  0/386 (0.00%) 
EPISTAXIS  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
HAEMOPTYSIS  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  0/386 (0.00%) 
Vascular disorders         
HYPERTENSION  1  1/4826 (0.02%)  0/2275 (0.00%)  0/467 (0.00%)  1/386 (0.26%) 
HYPOTENSION  1  0/4826 (0.00%)  1/2275 (0.04%)  0/467 (0.00%)  0/386 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention - Period 1 Control - Period 1 Intervention - Period 2 - Follow-up Only Control - Period 2- Follow-up Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4826 (0.00%)   0/2275 (0.00%)   0/467 (0.00%)   0/386 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 41 61 324 1111
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01256658     History of Changes
Other Study ID Numbers: CCOA566B2401
CCOA566B2401E1 ( Other Identifier: Novartis )
First Submitted: December 6, 2010
First Posted: December 8, 2010
Results First Submitted: July 23, 2013
Results First Posted: November 25, 2013
Last Update Posted: February 10, 2014