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    Clinical Trial Results:
    Phase 3, Open-Label, Randomized, Comparative Study to Evaluate Azithromycin plus Chloroquine and Sulfadoxine plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Malaria Infection in Pregnant Women in Africa

    Summary
    EudraCT number
    		 2014-004952-80
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Nov 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jun 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Few data issues/errors in this EU BR which were not present originally.

    Trial information

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    Trial identification
    Sponsor protocol code
    A0661158
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01103063
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To establish superiority of azithromycin/chloroquine (AZCQ) over sulfadoxine-pyrimethamine (SP) in protective efficacy for intermittent preventive treatment in pregnancy (IPTp) as measured by the proportion of subjects with sub-optimal pregnancy outcome.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Malawi: 611
    Country: Number of subjects enrolled
    Benin: 62
    Country: Number of subjects enrolled
    Tanzania, United Republic of: 839
    Country: Number of subjects enrolled
    Kenya: 1029
    Country: Number of subjects enrolled
    Uganda: 350
    Worldwide total number of subjects
    2891
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    142
    Adults (18-64 years)
    2749
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Phase 3, open label, randomized, parallel group study screened a total of 3259 subjects in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.

    Pre-assignment
    Screening details
    		 Pregnant women (all gravidae) with greater than equal to (≥) 14 and less than equal to (≤) 26 weeks of gestational age were to be enrolled in this study. Approximately half of the subjects were to be primigravidae and secundigravidae pregnant women since they had a higher risk for suboptimal pregnancy outcomes due to malaria.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Azithromycin + Chloroquine
    Arm description
    		 The subjects received Azithromycin (AZ) and Chloroquine (CQ) base by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azithromycin + Chloroquine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Azithromycin (AZ) and Chloroquine (CQ) was administered orally at a dose of 1000 mg AZ and 620 mg CQ (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), once daily for 3 days (Days 0, 1, 2) per treatment.

    Arm title
    		 Sulfadoxine + Pyrimethamine
    Arm description
    		 The subjects received sulfadoxine-pyrimethamine (SP) (Fansidar) single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sulfadoxine + Pyrimethamine
    Investigational medicinal product code
    Other name
    Fansidar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sulfadoxine-Pyrimethamine (SP) (Fansidar) was administered orally at a dose of 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg) on Day 0 of each treatment.

    Number of subjects in period 1
    		Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Started
    1446
    1445
    Completed
    969
    1024
    Not completed
    477
    421
         Consent withdrawn by subject
    60
    15
         Study terminated by Sponsor
    326
    342
         Adverse Event
    3
    1
         Death
    3
    1
         Not specified
    16
    11
         Protocol Violation
    1
    -
         Lost to follow-up
    68
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Azithromycin + Chloroquine
    Reporting group description
    		 The subjects received Azithromycin (AZ) and Chloroquine (CQ) base by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.

    Reporting group title
    Sulfadoxine + Pyrimethamine
    Reporting group description
    		 The subjects received sulfadoxine-pyrimethamine (SP) (Fansidar) single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.

    Reporting group values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine Total
    Number of subjects
    		 1446 1445 2891
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 23.3 ± 4.5 23.3 ± 4.6 -
    Gender categorical
    Units: Subjects
        Female
    		 1446 1445 2891
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Azithromycin + Chloroquine
    Reporting group description
    		 The subjects received Azithromycin (AZ) and Chloroquine (CQ) base by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.

    Reporting group title
    Sulfadoxine + Pyrimethamine
    Reporting group description
    		 The subjects received sulfadoxine-pyrimethamine (SP) (Fansidar) single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.

    Primary: Percentage Subjects With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population

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    End point title
    		 Percentage Subjects With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
    End point description
    Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (less than (<)2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (less than equal to (≤)28 weeks), still birth (greater than (>)28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. Intent To Treat (ITT) set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Primary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: Percentage of subjects
        number (confidence interval 95%)
    26.16 (23.89 to 28.43)
    23.67 (21.48 to 25.86)
    Statistical analysis title
    		 Sub-optimal Pregnancy in ITT Population
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12237
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.25
    Variability estimate
    Standard deviation
    Dispersion value
    0.0647

    Secondary: Percentage of Subjects With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population

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    End point title
    		 Percentage of Subjects With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
    End point description
    Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. Subset of ITT subjects: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1089
    1176
    Units: percentage of Psubjects
        number (confidence interval 95%)
    10.38 (8.57 to 12.19)
    10.12 (8.4 to 11.84)
    Statistical analysis title
    		 Sub-optimal Pregnancy Efficacy in PP Population
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2265
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.84117
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.31
    Variability estimate
    Standard deviation
    Dispersion value
    0.1243

    Secondary: Percentage of Neonates With LBW (<2500 g) in ITT Population

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    End point title
    		 Percentage of Neonates With LBW (<2500 g) in ITT Population
    End point description
    LBW was defined as live birth weight <2500 g (up to and including 2499 g). ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1140 [1]
    1190 [2]
    Units: percentage of neonates
        number (confidence interval 95%)
    5.01 (3.74 to 6.28)
    5.72 (4.4 to 7.04)
    Notes
    [1] - N=Total live births.
    [2] - N=Total live births.
    Statistical analysis title
    		 LBW in ITT Population
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4428
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.23
    Variability estimate
    Standard deviation
    Dispersion value
    0.1745

    Secondary: Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population

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    End point title
    		 Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
    End point description
    LBW was defined as live birth weight <2500 g (up to and including 2499 g). Subset of ITT subjects: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1041 [3]
    1134 [4]
    Units: percentage of neonates
        number (confidence interval 95%)
    4.72 (3.43 to 6.01)
    5.21 (3.92 to 6.5)
    Notes
    [3] - N=Total Live Births.
    [4] - N=Total Live Births.
    Statistical analysis title
    		 LBW in PP Population
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6086
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.31
    Variability estimate
    Standard deviation
    Dispersion value
    0.1882

    Secondary: Percentage of Subjects With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
    End point description
    Severe maternal anemia was defined as Hb <8 gram per decilite (g/dL). ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1222 [5]
    1299 [6]
    Units: percentage of subjects
        number (confidence interval 95%)
    1.08 (1.05 to 2.55)
    2 (1.24 to 2.76)
    Notes
    [5] - N=Number of subjects with Hb measurement at 36-38 weeks gestation.
    [6] - N=Number of subjects with Hb measurement at 36-38 weeks gestation.
    Statistical analysis title
    		 Severe Maternal Anemia at 36-38 Weeks
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.7035
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.57
    Variability estimate
    Standard deviation
    Dispersion value
    0.2866
    Notes
    [7] - Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.

    Secondary: Percentage of Subjects With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
    End point description
    Anemia was defined as Hb <11 g/dL. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation.
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1222 [8]
    1299 [9]
    Units: percentage of subjects
        number (confidence interval 95%)
    50.57 (47.77 to 53.37)
    49.11 (46.39 to 51.83)
    Notes
    [8] - N=Number of subjects with Hb measurement at 36-38 weeks gestation.
    [9] - N=Number of subjects with Hb measurement at 36-38 weeks gestation.
    Statistical analysis title
    		 Maternal Anemia at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2521
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4605
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.11
    Variability estimate
    Standard deviation
    Dispersion value
    0.04

    Secondary: Percentage of Subjects With Placental Parasitemia at Delivery

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    End point title
    		 Percentage of Subjects With Placental Parasitemia at Delivery
    End point description
    Subjects with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from subjects who deliver at hospital. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age.
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1019 [10]
    1076 [11]
    Units: percentage of subjects
        number (confidence interval 95%)
    5.3 (3.92 to 6.67)
    5.67 (4.29 to 7.05)
    Notes
    [10] - N=Number of subjects with placental parasite counts at delivery.
    [11] - N=Number of subjects with placental parasite counts at delivery.
    Statistical analysis title
    		 Placental Parasitemia Delivery
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2095
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7105
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.33
    Variability estimate
    Standard deviation
    Dispersion value
    0.1817

    Secondary: Percentage of Subjects With Placental Malaria at Delivery Based on Histology

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    End point title
    		 Percentage of Subjects With Placental Malaria at Delivery Based on Histology
    End point description
    Subjects positive for placental malaria at delivery were evaluated based on placental histology. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1040 [12]
    1100 [13]
    Units: percentage of subjects
        number (confidence interval 95%)
    4.81 (3.51 to 6.11)
    5.73 (4.36 to 7.1)
    Notes
    [12] - N=Number of subjects with a histology parasite evaluation at delivery.
    [13] - N=Number of subjects with a histology parasite evaluation at delivery.
    Statistical analysis title
    		 Placental Malaria
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2140
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3468
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.21
    Variability estimate
    Standard deviation
    Dispersion value
    0.1842

    Secondary: Sexually Transmitted Infection (STI) Episodes Per Subject

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    End point title
    		 Sexually Transmitted Infection (STI) Episodes Per Subject
    End point description
    Number of episodes of sexually transmitted infection episodes per subjects were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results). ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445 [14]
    1445 [15]
    Units: number of episodes
        least squares mean (confidence interval 95%)
    0.14 (0.11 to 0.16)
    0.19 (0.17 to 0.21)
    Notes
    [14] - N=Number of subjects with available data.
    [15] - N=Number of subjects with available data.
    Statistical analysis title
    		 STI Episodes Per Subjects
    Statistical analysis description
    Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs). The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0011
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Percentage of Subjects With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation

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    End point title
    		 Percentage of Subjects With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
    End point description
    Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), ND, CM, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445 [16]
    1445 [17]
    Units: percentage of subjects
        number (confidence interval 95%)
    28.51 (26.18 to 30.84)
    26.51 (24.23 to 28.79)
    Notes
    [16] - N=Total Outcomes.
    [17] - N=Total Outcomes.
    Statistical analysis title
    		 Sub-optimal Pregnancy:neonatal death, malformation
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2265
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.21
    Variability estimate
    Standard deviation
    Dispersion value
    0.0604

    Secondary: Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration

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    End point title
    		 Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration
    End point description
    Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Baseline, at 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1221 [18]
    1298 [19]
    Units: grams per deciliter (g/dL)
        least squares mean (confidence interval 95%)
    0.13 (0.05 to 0.21)
    0.27 (0.19 to 0.34)
    Notes
    [18] - N=Number of subjects with available data.
    [19] - N=Number of subjects with available data.
    Statistical analysis title
    		 Change;Baseline-36-38 Weeks;Hb concentration
    Statistical analysis description
    Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable. The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2519
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0131
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 -0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05

    Secondary: Percentage of Neonates With Congenital Abnormalities at Birth

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    End point title
    		 Percentage of Neonates With Congenital Abnormalities at Birth
    End point description
    Neonates with congenital abnormalities at birth were noted. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1140 [20]
    1190 [21]
    Units: percentage of neonates
        number (confidence interval 95%)
    2.19 (1.34 to 3.04)
    2.44 (1.56 to 3.31)
    Notes
    [20] - N=Number of total live births.
    [21] - N=Number of total live births.
    Statistical analysis title
    		 Neonates With Congenital Abnormalities at Birth
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6978
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.53
    Variability estimate
    Standard deviation
    Dispersion value
    0.2694

    Secondary: Percentage of Perinatal or Neonatal Deaths

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    End point title
    		 Percentage of Perinatal or Neonatal Deaths
    End point description
    Percentage of perinatal or neonatal deaths were noted. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Day 28 after delivery
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1140 [22]
    1190 [23]
    Units: percentage of neonates
        number (confidence interval 95%)
    2.19 (1.34 to 3.04)
    1.85 (1.08 to 2.62)
    Notes
    [22] - N=Number of total live births.
    [23] - N=Number of total live births.
    Statistical analysis title
    		 Percentage of Perinatal or Neonatal Deaths
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6542
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 2.01
    Variability estimate
    Standard deviation
    Dispersion value
    0.2908

    Secondary: Birth Weight of Live Borne Neonate

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    End point title
    		 Birth Weight of Live Borne Neonate
    End point description
    Birth weight of live borne neonates were calculated in grams. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1138 [24]
    1188 [25]
    Units: grams
        least squares mean (confidence interval 95%)
    3148.3 (3120 to 3176)
    3146.2 (3119 to 3174)
    Notes
    [24] - N=Number of live births with available data.
    [25] - N=Number of live births with available data.
    Statistical analysis title
    		 Birth Weight of Live Borne Neonate
    Statistical analysis description
    Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2326
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9145
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.5
         upper limit
    		 40.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    19.71

    Secondary: Number of Episodes of Symptomatic Malaria Per Subject From First Intermittent Preventive Treatment of Falciparum Dose to Delivery

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    End point title
    		 Number of Episodes of Symptomatic Malaria Per Subject From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
    End point description
    This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the subject presented with clinical symptoms of malaria (fever >37.5 degree celsius (°C), oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: number of episodes
        least squares mean (confidence interval 95%)
    0.06 (0.04 to 0.08)
    0.13 (0.11 to 0.15)
    Statistical analysis title
    		 Symptomatic Malaria
    Statistical analysis description
    Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria). The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01

    Secondary: Percentage of Subjects Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery

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    End point title
    		 Percentage of Subjects Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
    End point description
    This outcome measure evaluated the subjects requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results). ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: percentage of subjects
        number (confidence interval 95%)
    5.74 (4.54 to 6.94)
    10.52 (8.94 to 12.1)
    Statistical analysis title
    		 Additional Treatment for Symptomatic Malaria
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.62
    Variability estimate
    Standard deviation
    Dispersion value
    0.1221

    Secondary: Percentage of Subjects With Peripheral Parasitemia at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Peripheral Parasitemia at 36-38 Weeks of Gestation
    End point description
    This outcome measure evaluated the percentage of subjects positive for peripheral parasitemia at 36-38 weeks of gestation. A subjects was positive for parasitemia if the number of asexual parasites per microliter (μL) was >0. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1069 [26]
    1142 [27]
    Units: percentage of subjects
        number (confidence interval 95%)
    2.71 (1.74 to 3.68)
    4.38 (3.19 to 5.57)
    Notes
    [26] - N = Number of subjects with peripheral blood smear parasite counts at 36-38 weeks of gestation.
    [27] - N = Number of subjects with peripheral blood smear parasite counts at 36-38 weeks of gestation.
    Statistical analysis title
    		 Peripheral Parasitemia at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.97
    Variability estimate
    Standard deviation
    Dispersion value
    0.2295

    Secondary: Percentage of Subjects With Peripheral Parasitemia at Delivery

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    End point title
    		 Percentage of Subjects With Peripheral Parasitemia at Delivery
    End point description
    This outcome measure evaluated the percentage of subjects positive for peripheral parasitemia at delivery. A subject was positive for parasitemia if the number of asexual parasites per μL was >0. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1025 [28]
    1086 [29]
    Units: percentage of subjects
        number (confidence interval 95%)
    6.05 (4.59 to 7.51)
    7.46 (5.9 to 9.02)
    Notes
    [28] - N = Number of subjects with peripheral blood smear parasite counts at delivery.
    [29] - N = Number of subjects with peripheral blood smear parasite counts at delivery.
    Statistical analysis title
    		 Peripheral Parasitemia at Delivery
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2111
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1975
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1.12
    Variability estimate
    Standard deviation
    Dispersion value
    0.163

    Secondary: Percentage of Subjects With Cord Blood Parasitemia at Delivery

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    End point title
    		 Percentage of Subjects With Cord Blood Parasitemia at Delivery
    End point description
    This outcome measure evaluated the percentage of subjects positive for cord blood parasitemia at delivery. A subject was positive for parasitemia if the number of asexual parasites per μL was >0. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1015 [30]
    1072 [31]
    Units: percentage of subjects
        number (confidence interval 95%)
    0.49 (0.06 to 0.92)
    0.75 (0.23 to 1.27)
    Notes
    [30] - N = Number of subjects with cord blood smear parasite counts at delivery.
    [31] - N = Number of subjects with cord blood smear parasite counts at delivery.
    Statistical analysis title
    		 Cord Blood Parasitemia at Delivery
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2087
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4655
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 2.01
    Variability estimate
    Standard deviation
    Dispersion value
    0.5675

    Secondary: Percentage of Subjects With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
    End point description
    Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Up to 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: percentage of subjects
        number (confidence interval 95%)
    12.32 (10.63 to 14.01)
    16.47 (14.56 to 18.38)
    Statistical analysis title
    		 Sexually Transmitted Infections; 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.9
    Variability estimate
    Standard deviation
    Dispersion value
    0.0918

    Secondary: Percentage of Subjects With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
    End point description
    Subjects positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and polymerase chain reaction (PCR) assay was used for analysis. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    746 [32]
    794 [33]
    Units: percentage of subjects
        number (confidence interval 95%)
    1.47 (0.61 to 2.33)
    0.63 (0.08 to 1.18)
    Notes
    [32] - N=Number of sibjects with lab test results at 36-38 weeks of gestation.
    [33] - N=Number of sibjects with lab test results at 36-38 weeks of gestation.
    Statistical analysis title
    		 Chlamydia Trachomatis Infection at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    1540
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1113
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    2.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 6.66
    Variability estimate
    Standard deviation
    Dispersion value
    0.5338

    Secondary: Percentage of Subjects With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
    End point description
    Subjects positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    746 [34]
    794 [35]
    Units: percentage of subjects
        number (confidence interval 95%)
    0.4 (0 to 0.85)
    1.64 (0.76 to 2.52)
    Notes
    [34] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    [35] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    Statistical analysis title
    		 Neisseria Gonorrhoeae Infection at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    1540
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0284
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.86
    Variability estimate
    Standard deviation
    Dispersion value
    0.6386

    Secondary: Percentage of Subjects With Treponema Pallidum Infection at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Treponema Pallidum Infection at 36-38 Weeks of Gestation
    End point description
    Subjects positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    751 [36]
    797 [37]
    Units: percentage of subjects
        number (confidence interval 95%)
    0.93 (0.24 to 1.62)
    2.01 (1.04 to 2.98)
    Notes
    [36] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    [37] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    Statistical analysis title
    		 Treponema Pallidum Infection at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Sulfadoxine + Pyrimethamine v Azithromycin + Chloroquine
    Number of subjects included in analysis
    1548
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0188
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 0.88
    Variability estimate
    Standard deviation
    Dispersion value
    0.3291

    Secondary: Percentage of Subjects With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
    End point description
    Subjects positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1068 [38]
    1143 [39]
    Units: percentage of subjects
        number (confidence interval 95%)
    8.24 (6.59 to 9.89)
    10.67 (8.88 to 12.46)
    Notes
    [38] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    [39] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    Statistical analysis title
    		 Trichomonas Vaginalis Infection at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Sulfadoxine + Pyrimethamine v Azithromycin + Chloroquine
    Number of subjects included in analysis
    2211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0527
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1
    Variability estimate
    Standard deviation
    Dispersion value
    0.1336

    Secondary: Percentage of Subjects With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation

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    End point title
    		 Percentage of Subjects With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation
    End point description
    Bacterial vaginosis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    At 36-38 weeks of gestation
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    746 [40]
    794 [41]
    Units: percentage of subjects
        number (confidence interval 95%)
    8.58 (6.57 to 10.59)
    11.84 (9.59 to 14.09)
    Notes
    [40] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    [41] - N=Number of subjects with laboratory test results at 36-38 weeks of gestation.
    Statistical analysis title
    		 Bacterial Vaginosis Infection at 36-38 Weeks
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    1540
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0384
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.98
    Variability estimate
    Standard deviation
    Dispersion value
    0.1536

    Secondary: Percentage of Neonates With Ophthalmia Neonatorum at Birth Period

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    End point title
    		 Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
    End point description
    Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1140 [42]
    1190 [43]
    Units: percentage of neonates
        number (confidence interval 95%)
    0.35 (0.01 to 0.69)
    0.17 (0 to 0.4)
    Notes
    [42] - N=Total live births.
    [43] - N=Total live births.
    Statistical analysis title
    		 Neonates; Ophthalmia Neonatorum at Birth Period
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3942
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 11.38
    Variability estimate
    Standard deviation
    Dispersion value
    0.8648

    Secondary: Percentage of Subjects With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery

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    End point title
    		 Percentage of Subjects With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
    End point description
    Subjects positive for bacterial infections including other lower respiratory tract infections (LRTI) were measured anytime from first dose administration to delivery. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    Up to approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445 [44]
    1445 [45]
    Units: percentage of subjects
        number (confidence interval 95%)
    0.48 (0.13 to 0.84)
    1.25 (0.67 to 1.82)
    Notes
    [44] - N=Number of subjects with available data.
    [45] - N=Number of subjects with available data.
    Statistical analysis title
    		 Bacterial Infections;Pneumonia;LRTI
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Azithromycin + Chloroquine v Sulfadoxine + Pyrimethamine
    Number of subjects included in analysis
    2890
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0332
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.93
    Variability estimate
    Standard deviation
    Dispersion value
    0.4439

    Secondary: Percentage of Subjects With Pre-eclampsia From Week 20 to Delivery

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    End point title
    		 Percentage of Subjects With Pre-eclampsia From Week 20 to Delivery
    End point description
    Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 millimeter of mercury (mmHg) and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.
    End point type
    Secondary
    End point timeframe
    From Week 20 to approximately 40 weeks of gestational age
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1440 [46]
    1443 [47]
    Units: percentage of subjects
        number (confidence interval 95%)
    0.63 (0.22 to 1.03)
    1.04 (0.51 to 1.55)
    Notes
    [46] - N= Number of subjects with available data.
    [47] - N= Number of subjects with available data.
    Statistical analysis title
    		 Pre-Eclampsia; Week 20 to Delivery
    Statistical analysis description
    Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint). The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1. The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.
    Comparison groups
    Sulfadoxine + Pyrimethamine v Azithromycin + Chloroquine
    Number of subjects included in analysis
    2883
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2321
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.38
    Variability estimate
    Standard deviation
    Dispersion value
    0.4195

    Secondary: Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae

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    End point title
    		 Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
    End point description
    This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. Here "N"= Number of subject with nasopharyngeal swabs isolating Streptococcus pneumoniae at specified visit.
    End point type
    Secondary
    End point timeframe
    Visits 6 and 7
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: percentage of subjects
    number (not applicable)
        Visit 6 (N = 8, 17)
    0
    11.76
        Visit 7 (N = 16, 11)
    0
    0
    Attachments
    		 Statistical Analysis Attachment
    No statistical analyses for this end point

    Secondary: Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae

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    End point title
    		 Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
    End point description
    This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics. ITT set was used which consisted of subjects who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. Here "N"= Number of subject with nasopharyngeal swabs isolating Streptococcus pneumoniae at specified visit.
    End point type
    Secondary
    End point timeframe
    Visits 6 and 7
    End point values
    		 Azithromycin + Chloroquine Sulfadoxine + Pyrimethamine
    Number of subjects analysed
    1445
    1445
    Units: percentage of subjects
    number (not applicable)
        Visit 6 (N = 8, 17)
    0
    0
        Visit 7 (N = 16, 11)
    0
    0
    Attachments
    		 Statistical Analysis Attachment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates
    Adverse event reporting additional description
    Same event may appear as AE and SAE,what is presented are distinct events. Some events seen only in neonates (neonatal malformation/anomalies, LBW);not expected in mothers and vice versa. Such events designated as ‘0’ in respective ‘familial status- neonate/mother’. EU BR specific AE tables generated separately as per EU format using latest coding.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Mother (Azithromycin + Chloroquine)
    Reporting group description
    		 The subjects received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. Number of deaths due to adverse events = 3. Number of deaths related to treatment = 0.

    Reporting group title
    Neonate (Sulfadoxine + Pyrimethamine)
    Reporting group description
    		 Live births of subjects who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. Number of deaths due to adverse events = 22. Number of deaths related to treatment = 0.

    Reporting group title
    Neonate (Azithromycin + Chloroquine)
    Reporting group description
    		 Live births of subjects who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals. Number of deaths due to adverse events = 25. Number of deaths related to treatment = 0.

    Reporting group title
    Mother (Sulfadoxine + Pyrimethamine)
    Reporting group description
    		 The subjects received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals. Number of deaths due to adverse events = 1. Number of deaths related to treatment = 0.

    Serious adverse events
    		 Mother (Azithromycin + Chloroquine) Neonate (Sulfadoxine + Pyrimethamine) Neonate (Azithromycin + Chloroquine) Mother (Sulfadoxine + Pyrimethamine)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    65 / 1446 (4.50%)
    104 / 1196 (8.70%)
    101 / 1149 (8.79%)
    42 / 1445 (2.91%)
         number of deaths (all causes)
    3
    22
    25
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    2 / 1445 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous complete
         subjects affected / exposed
    2 / 1446 (0.14%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion threatened
         subjects affected / exposed
    4 / 1446 (0.28%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eclampsia
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Foetal death
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    2 / 1446 (0.14%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HELLP syndrome
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage in pregnancy
         subjects affected / exposed
    7 / 1446 (0.48%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Imminent abortion
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice neonatal
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    3 / 1149 (0.26%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low birth weight baby
         subjects affected / exposed
    0 / 1446 (0.00%)
    10 / 1196 (0.84%)
    9 / 1149 (0.78%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 10
    0 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    Neonatal disorder
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructed labour
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental disorder
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Placental infarction
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    2 / 1446 (0.14%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    5 / 1445 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    0 / 1446 (0.00%)
    12 / 1196 (1.00%)
    17 / 1149 (1.48%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 12
    0 / 17
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 6
    0 / 7
    0 / 0
    Premature delivery
         subjects affected / exposed
    7 / 1446 (0.48%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    5 / 1445 (0.35%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    4 / 1446 (0.28%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    4 / 1445 (0.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    2 / 1445 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Preterm premature rupture of membranes
         subjects affected / exposed
    4 / 1446 (0.28%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    3 / 1445 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    5 / 1446 (0.35%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    7 / 1445 (0.48%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    3 / 1445 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical cord around neck
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death neonatal
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 1446 (0.07%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal asphyxia
         subjects affected / exposed
    0 / 1446 (0.00%)
    9 / 1196 (0.75%)
    6 / 1149 (0.52%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 9
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 5
    0 / 4
    0 / 0
    Neonatal aspiration
         subjects affected / exposed
    0 / 1446 (0.00%)
    5 / 1196 (0.42%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 1446 (0.00%)
    4 / 1196 (0.33%)
    2 / 1149 (0.17%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 1446 (0.00%)
    3 / 1196 (0.25%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    3 / 1149 (0.26%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Investigations
    Apgar score low
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    HIV test positive
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Uterine rupture
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Anal atresia
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cerebellar hypoplasia
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Congenital hand malformation
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital malaria
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    3 / 1149 (0.26%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital umbilical hernia
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    2 / 1149 (0.17%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystic lymphangioma
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Dysmorphism
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exomphalos
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart disease congenital
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hypospadias
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    2 / 1149 (0.17%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microgenia
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Polydactyly
         subjects affected / exposed
    0 / 1446 (0.00%)
    21 / 1196 (1.76%)
    16 / 1149 (1.39%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 21
    0 / 16
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Talipes
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tricuspid valve disease
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 1446 (0.07%)
    2 / 1196 (0.17%)
    3 / 1149 (0.26%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic disease of newborn
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 1446 (0.21%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising colitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectourethral fistula
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 1446 (0.00%)
    3 / 1196 (0.25%)
    2 / 1149 (0.17%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis cholestatic
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal vessel disorder
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bartholin's abscess
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 1446 (0.00%)
    2 / 1196 (0.17%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    2 / 1446 (0.14%)
    3 / 1196 (0.25%)
    2 / 1149 (0.17%)
    9 / 1445 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 1446 (0.07%)
    1 / 1196 (0.08%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    Neonatal infection
         subjects affected / exposed
    0 / 1446 (0.00%)
    4 / 1196 (0.33%)
    5 / 1149 (0.44%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1446 (0.07%)
    10 / 1196 (0.84%)
    9 / 1149 (0.78%)
    1 / 1445 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
    0 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1446 (0.07%)
    3 / 1196 (0.25%)
    2 / 1149 (0.17%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Sepsis neonatal
         subjects affected / exposed
    0 / 1446 (0.00%)
    13 / 1196 (1.09%)
    11 / 1149 (0.96%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 13
    0 / 11
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    2 / 1445 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 1446 (0.07%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 1446 (0.00%)
    0 / 1196 (0.00%)
    1 / 1149 (0.09%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 1446 (0.00%)
    1 / 1196 (0.08%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Mother (Azithromycin + Chloroquine) Neonate (Sulfadoxine + Pyrimethamine) Neonate (Azithromycin + Chloroquine) Mother (Sulfadoxine + Pyrimethamine)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1177 / 1446 (81.40%)
    326 / 1196 (27.26%)
    301 / 1149 (26.20%)
    888 / 1445 (61.45%)
    Pregnancy, puerperium and perinatal conditions
    Low birth weight baby
         subjects affected / exposed
    0 / 1446 (0.00%)
    39 / 1196 (3.26%)
    29 / 1149 (2.52%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    39
    29
    0
    Premature baby
         subjects affected / exposed
    0 / 1446 (0.00%)
    28 / 1196 (2.34%)
    28 / 1149 (2.44%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    28
    28
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    239 / 1446 (16.53%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    40 / 1445 (2.77%)
         occurrences all number
    239
    0
    0
    40
    Fatigue
         subjects affected / exposed
    81 / 1446 (5.60%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    22 / 1445 (1.52%)
         occurrences all number
    81
    0
    0
    22
    Pyrexia
         subjects affected / exposed
    10 / 1446 (0.69%)
    28 / 1196 (2.34%)
    40 / 1149 (3.48%)
    26 / 1445 (1.80%)
         occurrences all number
    10
    28
    40
    26
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    15 / 1446 (1.04%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    10 / 1445 (0.69%)
         occurrences all number
    15
    0
    0
    10
    Investigations
    White blood cells urine positive
         subjects affected / exposed
    149 / 1446 (10.30%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    162 / 1445 (11.21%)
         occurrences all number
    149
    0
    0
    162
    Injury, poisoning and procedural complications
    Perineal injury
         subjects affected / exposed
    19 / 1446 (1.31%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    20 / 1445 (1.38%)
         occurrences all number
    19
    0
    0
    20
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    460 / 1446 (31.81%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    84 / 1445 (5.81%)
         occurrences all number
    460
    0
    0
    84
    Headache
         subjects affected / exposed
    300 / 1446 (20.75%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    219 / 1445 (15.16%)
         occurrences all number
    300
    0
    0
    219
    Somnolence
         subjects affected / exposed
    38 / 1446 (2.63%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    0 / 1445 (0.00%)
         occurrences all number
    38
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    205 / 1446 (14.18%)
    14 / 1196 (1.17%)
    21 / 1149 (1.83%)
    192 / 1445 (13.29%)
         occurrences all number
    205
    14
    21
    192
    Eye disorders
    Vision blurred
         subjects affected / exposed
    145 / 1446 (10.03%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    1 / 1445 (0.07%)
         occurrences all number
    145
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    123 / 1446 (8.51%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    50 / 1445 (3.46%)
         occurrences all number
    123
    0
    0
    50
    Abdominal pain
         subjects affected / exposed
    120 / 1446 (8.30%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    36 / 1445 (2.49%)
         occurrences all number
    120
    0
    0
    36
    Abdominal pain lower
         subjects affected / exposed
    50 / 1446 (3.46%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    45 / 1445 (3.11%)
         occurrences all number
    50
    0
    0
    45
    Diarrhoea
         subjects affected / exposed
    205 / 1446 (14.18%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    14 / 1445 (0.97%)
         occurrences all number
    205
    0
    0
    14
    Dyspepsia
         subjects affected / exposed
    8 / 1446 (0.55%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    15 / 1445 (1.04%)
         occurrences all number
    8
    0
    0
    15
    Gastritis
         subjects affected / exposed
    23 / 1446 (1.59%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    7 / 1445 (0.48%)
         occurrences all number
    23
    0
    0
    7
    Nausea
         subjects affected / exposed
    216 / 1446 (14.94%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    58 / 1445 (4.01%)
         occurrences all number
    216
    0
    0
    58
    Vomiting
         subjects affected / exposed
    650 / 1446 (44.95%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    96 / 1445 (6.64%)
         occurrences all number
    650
    0
    0
    96
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    46 / 1446 (3.18%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    23 / 1445 (1.59%)
         occurrences all number
    46
    0
    0
    23
    Pruritus generalised
         subjects affected / exposed
    22 / 1446 (1.52%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    8 / 1445 (0.55%)
         occurrences all number
    22
    0
    0
    8
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    33 / 1446 (2.28%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    29 / 1445 (2.01%)
         occurrences all number
    33
    0
    0
    29
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 1446 (0.00%)
    10 / 1196 (0.84%)
    15 / 1149 (1.31%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    10
    15
    0
    Gastroenteritis
         subjects affected / exposed
    44 / 1446 (3.04%)
    37 / 1196 (3.09%)
    48 / 1149 (4.18%)
    21 / 1445 (1.45%)
         occurrences all number
    44
    37
    48
    21
    Infection parasitic
         subjects affected / exposed
    14 / 1446 (0.97%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    18 / 1445 (1.25%)
         occurrences all number
    14
    0
    0
    18
    Malaria
         subjects affected / exposed
    49 / 1446 (3.39%)
    37 / 1196 (3.09%)
    37 / 1149 (3.22%)
    121 / 1445 (8.37%)
         occurrences all number
    49
    37
    37
    121
    Pneumonia
         subjects affected / exposed
    0 / 1446 (0.00%)
    25 / 1196 (2.09%)
    34 / 1149 (2.96%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    25
    34
    0
    Sepsis
         subjects affected / exposed
    0 / 1446 (0.00%)
    9 / 1196 (0.75%)
    18 / 1149 (1.57%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    9
    18
    0
    Sepsis neonatal
         subjects affected / exposed
    0 / 1446 (0.00%)
    21 / 1196 (1.76%)
    21 / 1149 (1.83%)
    0 / 1445 (0.00%)
         occurrences all number
    0
    21
    21
    0
    Trichomoniasis
         subjects affected / exposed
    58 / 1446 (4.01%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    55 / 1445 (3.81%)
         occurrences all number
    58
    0
    0
    55
    Upper respiratory tract infection
         subjects affected / exposed
    127 / 1446 (8.78%)
    116 / 1196 (9.70%)
    125 / 1149 (10.88%)
    153 / 1445 (10.59%)
         occurrences all number
    127
    116
    125
    153
    Urinary tract infection
         subjects affected / exposed
    105 / 1446 (7.26%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    115 / 1445 (7.96%)
         occurrences all number
    105
    0
    0
    115
    Vulvovaginal candidiasis
         subjects affected / exposed
    75 / 1446 (5.19%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    60 / 1445 (4.15%)
         occurrences all number
    75
    0
    0
    60
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    44 / 1446 (3.04%)
    0 / 1196 (0.00%)
    0 / 1149 (0.00%)
    11 / 1445 (0.76%)
         occurrences all number
    44
    0
    0
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Mar 2013
    1. A new key secondary endpoint which was comprised of the primary endpoint for sub-optimal pregnancy outcome (as defined) and the addition of congenital malformations and neonatal deaths.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This program was terminated by Pfizer based on the results of the pre-planned interim analysis for this pivotal study. The interim analysis showed no benefit of the study drug (AZCQ) compared to standard of care (SP).
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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