Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
Official Title
Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)
Acronym
PROMISE
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 1, 2011Actual
Primary Completion Date
Sep 30, 2016Actual
Completion Date
Sep 30, 2016Actual
First Submitted Date
Feb 1, 2010
First Submission Date that Met QC Criteria
Feb 1, 2010
First Posted Date
Feb 2, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 28, 2017
Results First Submitted that Met QC Criteria
Jan 12, 2018
Results First Posted Date
Feb 9, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 9, 2022
Last Update Posted Date
Feb 11, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants:
What is the optimal intervention for the prevention of antepartum and intrapartum transmission of HIV?
What is the optimal intervention for the prevention of postpartum transmission in breastfeeding (BF) infants?
What is the optimal intervention for the preservation of maternal health after the risk period for prevention of mother-to-child-transmission ends (either at delivery or cessation of BF)?
The overall PROMISE protocol had three separate interventional components to address each of these three questions and was conducted at locations in Africa and other parts of the world. Due to variations in the standard of care for HIV-infected pregnant and postpartum women and their infants at different sites, not all of these questions were relevant. Therefore, two separate versions of the PROMISE protocol were developed, each containing only the relevant components. The 1077BF protocol was used at sites where the standard method of infant feeding was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of infant feeding was formula feeding. The analyses were collapsed across the two protocol versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF protocols.
Detailed Description
The incidence of mother-to-child transmission (MTCT) of HIV has decreased in recent years in the United States, Europe, and other resource-advantaged countries. Several factors have contributed to this decrease, including the administration of HAART during pregnancy, caesarean section delivery methods, and the use of formula instead of breastfeeding to feed infants. However, in resource-limited countries, the incidence of pediatric HIV infection remains high. Many pregnant women in these countries do not receive an adequate course of HAART, and the majority breastfeed their children.
This study was divided into three components (Antepartum, Postpartum, and Maternal Health Components). The following is a description of each of the three open label sequential randomization components, each designed to address one of the following three main objectives:
Antepartum Component: This PROMISE component compared the safety and efficacy of different HAART regimens for preventing the transmission of HIV during pregnancy, labor, and delivery.
Participants were randomly assigned to one of the following three arms:
Maternal Regimens:
Arm A : 1) Zidovudine (ZDV) from study entry through delivery, 2) single dose nevirapine (sdNVP) and emtricitabine-tenofovir disoproxil (TRV ) intrapartum, and 3) TRV postpartum for up to 14 days post-partum. Arm A is also labeled as ZDV+sdNVP+TRV tail.
Arm B: Lamivudine (3TC)-zidovudine (ZDV) + lopinavir (LPV)-ritonavir (RTV) from study entry up to 14 days postpartum. Arm B is also labeled as 3TC-ZDV/LPV-RTV.
Arm C: TRV/LPV-RTV from study entry up to 14 days postpartum. Arm C is also labeled as FTC-TDF/LPV-RTV.
All infants born to women enrolled in this study were to receive NVP once a day as soon as possible after birth through 42 days of age or until the Week 6 study visit, whichever was later. Women switched or initiated HAART if it was needed for their own health.
During pregnancy, participants attended study visits at study entry, 2 and 4 weeks after entry, and then every 4 weeks until labor and delivery. Women and infants were monitored during labor and delivery and attended a study visit 6 to 14 days after delivery. After delivery, eligibility criteria were assessed for subsequent randomizations (either Postpartum or Maternal Health). If they failed the entry criteria for the subsequent randomization, the mothers remained in follow-up for safety assessments and the infants were followed until the 104 week visit; otherwise they were followed under the subsequent component.
All three antepartum arms were not available to all women throughout the PROMISE study. When the trial began, there were limited safety data on tenofovir in pregnancy, and randomization to tenofovir-based ART was limited to women coinfected with HIV and HBV, because benefit was felt to outweigh risk in that group. During period 1 (PROMISE protocol version 2.0 - April 2011 through September 2012), women without HBV coinfection were randomized to either Arm A or Arm B; and Hepatitis B (HBV) co-infected women were randomized to either Arm A, Arm B, or Arm C. However, in October 2012, with increased data on tenofovir in pregnancy, the protocol was modified to allow women regardless of HBV status to be assigned to any of the three regimens during period 2 (PROMISE protocol version 3.0 - October 2012 through the end of antepartum enrollment on October 1, 2014). By arm comparisons were restricted to times in which there were contemporaneous randomizations.
Late Presenters: In addition the Antepartum Component, participants could enter PROMISE through the Late Presenters Registration (LP). Late presenters were identified in early or active labor or in the immediate postpartum period (up to 5 days postpartum). The Late Presenters Registration facilitated a structure to screen women and infants for randomization in the Postpartum Component. Women and infants not randomized in the Postpartum Component of PROMISE were followed through the Week 6 visit.
There were 3543 mothers and 3407 live born infants enrolled in the Antepartum Component. There were 204 mothers and 204 live born infants in the Late Presenters Registration.
Postpartum Component: This PROMISE component compared the safety and efficacy of maternal triple ARV prophylaxis versus daily infant NVP prophylaxis for the prevention of mother-to-child transmission (PMTCT) through breastfeeding. The Postpartum Component consisted of mothers and infants from the Antepartum Component and the Late Presenters Registration who passed the Postpartum Component entry criteria.
Participants were randomly assigned to one of two arms:
Arm A: Women received LPV-RTV plus TRV from the Week 1 postpartum visit through the end of maternal follow-up (2 to 5 years). Infants received NVP once a day through 42 days of age or until the Week 6 study visit, whichever was later.
Arm B: Infants received NVP once a day from the Week 1 postpartum visit until the end of risk for MTCT or until 18 months postpartum (104 weeks). Women did not receive antiretroviral drugs for MTCT prophylaxis.
The maternal study visits were at entry, at postpartum weeks 6, 14, 26, and every 12 weeks thereafter. Infant study visits were at entry, every 4 weeks between postpartum weeks 6-26, every 12 weeks between postpartum week 38-98, and at postpartum week 104. At the end of risk for MTCT or 18 months postpartum, the mothers' eligibility criteria were assessed for a subsequent randomization in the Maternal Health Component. If they did not meet entry criteria for the Maternal Health randomization, they remained in follow-up for safety assessments; otherwise they were followed under the Maternal Health Component. Infants were followed until the 104 week visit.
Women switched or initiated HAART if it was needed for their own health. If a woman in Arm B initiated HAART then her infant discontinued NVP after 12 weeks of HAART or after her viral load was suppressed, whichever came first.
There were 2431 mothers and 2444 infants randomized as part of the Postpartum Component.
Maternal Health Component: This PROMISE component randomized women to continue or discontinue HAART after the end of risk for MTCT, either after delivery or after breastfeeding. Participants included women who were receiving the triple ARV regimen in the Postpartum Component; or receiving the triple ARV regimen in the Antepartum Component and were ineligible for the Postpartum Component.
Participants were randomly assigned to one of two study arms:
Arm A: Participants continued to receive the triple ARV regimen (preferred regimen was LPV-RTV plus TRV).
Arm B: Participants discontinued the triple ARV regimen.
Study visits occurred at Weeks 4 and 12 and then every 3 months thereafter. Study visits included a medical history review, questionnaires, physical exam, and blood collection. Women switched or initiated a triple ARV regimen if it was needed for their own health.
There were 875 mothers randomized as part of the Maternal Health Component.
The analyses for the Maternal Health Component we not solely based on the Maternal Health Randomization. Instead there were four prespecified comparison groups for the Maternal Health Component. The four comparison groups used the three randomizations as appropriate to answer the following questions:
Question 1: What is the effect on women of using a maternal triple ARV regimen to prevent MTCT during pregnancy, relative to using ZDV + sdNVP + TRV tail to prevent MTCT during pregnancy?
Question 2: What is the effect on women of using a maternal triple ARV regimen to prevent MTCT during breastfeeding, relative to using infant NVP to prevent MTCT during breastfeeding?
Question 3: What is the effect on women of extending versus discontinuing the antepartum/intrapartum maternal triple ARV regimen at the time of birth?
Question 4: What is the effect on women of extending versus discontinuing the postpartum maternal triple ARV regimen after the cessation of risk for MTCT during breastfeeding?
There were 1602 mothers included in the analyses for Question 2.
PROMISE mothers were followed for 2 to 5 years, depending on when they enrolled. Infants were followed up to 104 weeks of age. Infant and maternal follow-up ended in September 2016. PROMISE randomizations were halted in the summer of 2014 due to slow accrual to the Later Presenters Registration and the Formula Feeding protocol. Due to the results of an external study, on July 7th 2015 the PROMISE interventions were halted and ART was offered to all participants. Per recommendation from the Data and Safety and Monitoring Board on November 4th 2014, the primary analyses for the Antepartum Component include follow-up through September 10th, 2014. Per recommendation from the Data and Safety and Monitoring Board on November 12th 2015, the primary analyses for the Postpartum Component include follow-up through July 7th, 2015. The Adverse Events in the Reported Adverse Event section include all study follow-up.
Registration to facilitate a structure to screen women and infants for randomization in the Postpartum Component.
Other: No Intervention
Postpartum Arm A (Maternal Prophylaxis)
Experimental
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Zidovudine (ZDV)
Drug
300 mg twice daily
Antepartum Arm A
Nevirapine (NVP): Antepartum Mothers
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Antepartum Component: Number of Confirmed Infant HIV Infections
Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point
Measured at birth or Week 1 study visit
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
Measured through the Week 1 postpartum study visit
Antepartum Component: Number of Mothers With Obstetrical Complications
Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as "Pregnancy, puerperium and perinatal conditions", except if the condition was the death of the fetus: "Abortions not specified as induced or spontaneous", "Abortions spontaneous", or "Stillbirth and foetal death."
Measured through the Week 1 postpartum study visit
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
Composite outcome
Measured at birth
Postpartum Component: Incidence of Confirmed Infant HIV Infection
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.
Secondary Outcomes
Measure
Description
Time Frame
Antepartum Component: Number of Infant HIV Infections
Detected by HIV NAT positivity
Measured at the birth (<= 3 days postpartum) visit
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
Other Outcomes
Measure
Description
Time Frame
Maternal Health Component: Cost-effectiveness
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.
From study entry until July 7, 2015.
Eligibility Module
Eligibility Criteria
Antepartum Component Inclusion Criteria:
Confirmed HIV-1 infection, defined as documented positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.
Currently pregnant and greater than or equal to 14 weeks gestation based on clinical or other obstetrical measurements
CD4 count greater than or equal to 350 cells/mm^3, or greater than or equal to the country-specific threshold for initiation of treatment (if that threshold is greater than 350 cells/mm^3), on a specimen obtained within 30 days prior to study entry
Results of HBV screening (HBsAg testing) available from specimen obtained within 30 days prior to study entry
The following laboratory values from a specimen obtained within 30 days prior to study entry:
Hemoglobin greater than or equal to 7.5 g/dL
White blood cell count (WBC) greater than or equal to 1,500 cells/mm^3
Absolute neutrophil count (ANC) greater than or equal to 750 cells/mm^3
Platelets greater than or equal to 50,000 cells/mm^3
Alanine aminotransferase (ALT) less than or equal to 2.5 times the upper limit of normal (ULN)
Estimated creatinine clearance of greater than or equal to 60 mL/min using the Cockroft-Gault equation for women
Plans to deliver in the study-affiliated clinic or hospital
Has no plans to move outside of the study site area during the 24 months following delivery
Age of legal majority for the respective country and willing and able to provide written informed consent
Antepartum Component Exclusion Criteria:
Participation in PROMISE for a prior pregnancy
Ingestion of any antiretroviral (ARV) regimen with three or more drugs (regardless of duration) or more than 30 days of a single or dual ARV regimen during current pregnancy, according to self report or available medical records
Requires triple ARV therapy (HAART) for own health based on local standard guidelines
World Health Organization (WHO) stage 4 disease
Prior receipt of HAART for maternal treatment indications (e.g., CD4 less than 350 cells/mm^3 or clinical indications); however, could have received ARVs for the sole purpose of prevention of mother-to-child transmission (PMTCT) in previous pregnancies (prior PMTCT regimens could have included a triple ARV regimen, ZDV, 3TC-ZDV, and/or sdNVP for PMTCT, as well as use of a short dual nucleoside reverse transcriptase inhibitor [NRTI] "tail" to reduce risk of NVP resistance.)
In labor - at onset or beyond (may be eligible for the Late Presenter registration)
Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Current or history of tuberculosis (TB) disease (positive PPD without TB disease is not exclusionary)
Use of prohibited medications within 14 days prior to study entry (refer to the protocol for a list of prohibited medications)
Fetus detected to have serious congenital malformation (ultrasound not required to rule out this condition)
Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block [also known as Mobitz I or Wenckebach] is not considered exclusionary)
Known to meet the local standard criteria for treatment of HBV (Note: HBV DNA testing or other specialized assessments are not expected to be performed as part of this study. A woman would be excluded only if this information is documented from other sources and she meets the local standard criteria for HBV treatment based on those assessments.)
Social or other circumstances that would hinder long-term follow-up, in the opinion of the site investigator
Currently incarcerated
Late Presenter Inclusion Criteria:
Age of legal majority for the respective country
HIV-1 infection, defined as documented positive results from tests performed on one sample at any time prior to Late Presenter Registration
In labor (from onset/early labor or beyond) or within 5 days after delivery (with day of delivery considered day 0)
Has provided written informed consent
Has no plans to move outside of the study site area during the 24 months following delivery
If delivered, infant alive and healthy (In the case of a multiple birth, a mother-infant pair will be included in the Late Presenter registration only if both/all infants and the mother meet the eligibility criteria. If only one infant of a multiple birth is alive, the M-I pair may be registered if the infant and the mother otherwise meet all of the eligibility criteria.)
Late Presenter Exclusion Criteria:
Participation in PROMISE in prior pregnancy
Ingestion of any antiretroviral regimen during current pregnancy (including for solely for PMTCT), according to self report and available medical records (Note: Use of ARVs provided as standard of care for PMTCT during labor/delivery or postpartum prior to Late Presenter registration is not exclusionary.)
If known: CD4 count < 350 cells/mm3 or below the country-specific threshold for initiation of treatment, if that threshold is > 350 cells/mm3, on specimen obtained within 30 days prior to study entry (result not required prior to registration)
Requires triple ARV therapy (HAART) for own health according to local standard guidelines
WHO Stage 4 disease
Prior receipt of HAART for maternal treatment indications (e.g., CD4 < 350 cells/mm3 or clinical indications); however, could have received ARVs for the sole purpose of PMTCT in previous pregnancies. (Prior PMTCT regimens could have included a triple ARV regimen, ZDV, 3TCZDV and/or sdNVP for PMTCT, as well as use of a short dual NRTI "tail" to reduce risk of NVP resistance.)
Current or history of TB disease (positive PPD without TB disease is not exclusionary)
Known positive infant HIV nucleic acid test (NAT) result (result not required prior to registration)
Fetal demise or early neonatal death (prior to enrollment/registration)
Fetus detected with serious congenital malformation (ultrasound not required to rule out this condition)
Life threatening infant illness or birth condition incompatible with life
If delivered, infant birth weight < 2.0 kg
Social or other circumstances which would hinder long-term follow-up, in the opinion of the site investigator
Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block (also known as Mobitz I or Wenckebach) is not considered exclusionary)
Postpartum Component Inclusion Criteria:
Participation in the Antepartum Component or registered as a Late Presenter
Provided written informed consent
Has no plans to move outside of the study site area during the 24 months following delivery
Maternal CD4 count greater than or equal to 350 cells/mm^3, or greater than or equal to the country-specific threshold for initiation of treatment (if that threshold is greater than 350 cells/mm^3), from a specimen obtained within 30 days prior to study entry. More information on this criterion can be found in the protocol.
The following maternal laboratory values within 30 days prior to entry:
Hemoglobin greater than or equal to 7.0 g/dL
WBC greater than or equal to 1,500 cells/mm^3
ANC greater than or equal to 750 cells/mm^3
Platelets greater than or equal to 50,000 cells/mm^3
ALT less than or equal to 2.5 times the upper limit of normal (ULN)
Estimated creatinine clearance of greater than or equal to 60 mL/min using the Cockroft-Gault equation for women
Infant alive, healthy, less than or equal to 14 days of age, and uninfected (negative HIV NAT result on specimen drawn prior to study entry)
The following infant lab values on specimen obtained prior to study entry (within 14 days of birth):
Hemoglobin greater than or equal to 10 g/dL
WBC greater than or equal to 1,500 cells/mm^3
ANC greater than or equal to 750 cells/mm^3
Platelets greater than or equal to 50,000 cells/mm^3
ALT less than or equal to 2.5 times the ULN
For Registered Late Presenters: Confirmed maternal HIV-1 infection, defined as documented positive results from two samples collected at different time points at any time prior to entry. More information on this criterion can be found in the protocol.
Postpartum Component Exclusion Criteria:
Positive infant HIV NAT result on specimen drawn prior to entry or no infant HIV NAT result on specimen drawn prior to entry
Life-threatening infant illness or birth condition incompatible with life
Infant birth weight less than 2.0 kg
Social or other circumstances that would hinder long-term follow-up, as judged by the site investigator
Current or history of TB disease (positive PPD without TB disease is not exclusionary)
Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block [also known as Mobitz I or Wenckebach] is not considered exclusionary)
Requires triple ARV therapy (HAART) for own health
Maternal Health Component Inclusion Criteria:
Randomly assigned to triple ARV prophylaxis as part of the Postpartum Component and has continued triple ARV prophylaxis until the current randomization without treatment interruption (defined as more than 14 consecutive days of missed dosing) within the previous 30 days; OR randomly assigned to triple ARV prophylaxis in the Antepartum Component but ineligible for the Postpartum Component and has continued triple ARV prophylaxis until the current randomization without treatment interruption (defined as more than 7 consecutive days of missed dosing) within the previous 30 days
Within two weeks after complete breastfeeding cessation is achieved (defined as completely stopping all exposure to breast milk for greater than or equal to 28 days); i.e., within 29 to 42 days of last breast milk exposure, or reached 18 months postpartum (whichever comes first). Women who reach 18 months postpartum while still breastfeeding will be eligible for entry within 2 weeks before and 4 weeks after the Week 74 visit (Week 72-78); OR if the woman was randomized to triple ARV prophylaxis in the Postpartum Component and her infant is infected and still breastfeeding, she will be eligible for the Maternal Health Component within 42 days of specimen collection for the confirmatory infant HIV NAT; OR if the woman was randomized to triple ARV prophylaxis in the Antepartum Component but mother-infant pair was ineligible for the Postpartum Component she will be eligible for the Maternal Health Component beginning at the Week 1 visit (6-14 days postpartum) through 28 days after delivery; these women should be randomized as soon as possible, ideally within 6-14 days after delivery; OR if the woman was randomized to triple ARV prophylaxis in the Postpartum Component and breastfeeding risk for MTCT ceases for other reasons (e.g., infant death or permanent removal from home through legal services or adoption) within 28 days of event. More information on this criterion can be found in the protocol.
Provided written informed consent
CD4 cell count greater than or equal to 350 cells/mm^3, or greater than or equal to the country-specific threshold for initiation of treatment (if that threshold is greater than 350 cells/mm^3), on a specimen obtained within 30 days prior to study entry
The following laboratory values on a specimen obtained within 30 days prior to study entry:
ANC greater than or equal to 750 cells/mm^3
Hemoglobin greater than or equal to 7.0 gm/dL
Platelet count greater than or equal to 50,000 cells/mm^3
ALT (SGPT) less than or equal to 2.5 times the ULN
Estimated creatinine clearance of greater than or equal to 60 mL/min using the Cockroft-Gault equation for women
Intend to remain in current geographical area of residence for the duration of study
Maternal Health Component Exclusion Criteria:
WHO Stage 4 disease
Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry
Current or history of TB disease (positive PPD without TB disease is not exclusionary)
Use of prohibited medications within 14 days prior to study entry
Social or other circumstances that would hinder long term follow-up as judged by the site investigator
Current documented conduction heart defect (specialized assessments to rule out this condition are not required; a heart murmur alone and/or type 1 second-degree atrioventricular block [also known as Mobitz I or Wenckebach] is not considered exclusionary)
Requires a triple ARV regimen for own health
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Mary Glenn Fowler, MD, MPH
Johns Hopkins Medical Institute, Makerere U.-JHU Research Collaboration
Taha T, Nour S, Li Q, Kumwenda N, Kafulafula G, Nkhoma C, Broadhead R. The effect of human immunodeficiency virus and breastfeeding on the nutritional status of African children. Pediatr Infect Dis J. 2010 Jun;29(6):514-8. doi: 10.1097/INF.0b013e3181cda531.
Becquet R, Ekouevi DK, Arrive E, Stringer JS, Meda N, Chaix ML, Treluyer JM, Leroy V, Rouzioux C, Blanche S, Dabis F. Universal antiretroviral therapy for pregnant and breast-feeding HIV-1-infected women: towards the elimination of mother-to-child transmission of HIV-1 in resource-limited settings. Clin Infect Dis. 2009 Dec 15;49(12):1936-45. doi: 10.1086/648446.
200 mg/300 mg x 2 tablets at onset of labor or as soon as possible thereafter; 200 mg/300 mg orally each day after delivery for 7 days or the date of the Week 1 visit (up to 14 days), whichever is later.
Antepartum Arm A
Lamivudine-Zidovudine (3TC-ZDV)
Drug
150 mg/300 mg twice daily
Antepartum Arm B
Lopinavir-ritonavir (LPV-RTV)
Drug
400 mg/100 mg twice daily beginning at >= 14 weeks gestation; 600 mg/150 mg twice daily beginning at >= 28 weeks gestation or at next visit (during third trimester) through delivery; 400 mg/100 mg twice daily after delivery up to 14 days postpartum.
Oral suspension (dosing according to birth weight) once a day through 42 days of age or through the week 6 visit, whichever is later.
Antepartum Arm A
Antepartum Arm B
Antepartum Arm C
Postpartum Arm A (Maternal Prophylaxis)
Nevirapine (NVP): Infant extended
Drug
Oral suspension (dosing according to birth weight) once a day from 6 (up to 14) days of age until there was no longer any risk of MTCT or until the end of follow-up (104 weeks), whichever came first.
Postpartum Arm B (Infant Prophylaxis)
No Intervention
Other
Women registered before/during labor received the full Antepartum Arm A regimen.
Women registered after labor, and who received nevirapine outside of the study, received the Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail.
Late Presenters
Discontinue triple ARVs
Other
ARVs were discontinued. When protocol specified criteria were met, mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).
Maternal Health Arm B (Discontinue triple ARVs)
Continue triple ARVs
Other
Mothers could be prescribed any licensed antiretroviral medication, as long as the treatment met the definition of HAART (three ARV drugs from two or more drug classes).
Maternal Health Arm A (Continue triple ARVs)
Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function.
Measured from birth through 104 weeks of age
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
Analysis used the principle of intent to treat.
Measured at the time of delivery
Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.
Measured through 24 months post-delivery
Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair)
Measured at 12 and 24 months post-delivery
Maternal Health Component: Incidence of Death
Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence of AIDS-defining Illness
"AIDS-defining illness" refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence of HIV/AIDS-related Events
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events
Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.
Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Other Targeted Medical Conditions
Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence of HIV/AIDS-related Event or Death
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence of Tuberculosis
Incidence of tuberculosis.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 ("Severe"). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic.
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Maternal Health Component: Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since inflammation and thrombogenic markers were not a focus of the study.
From study entry until July 7, 2015.
Maternal Health Component: Quality of Life
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since quality of life was not a focus of the study.
From study entry until July 7, 2015.
Maternal Health Component: Self-reported Adherence
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.
From study entry until July 7, 2015.
Maternal Health Component: Viral Resistance
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.
From study entry until July 7, 2015.
Postpartum Component: Functional Maternal Antibody and HIV-envelope Binding Responses in Breast Milk and Plasma, Until Cessation of Breastfeeding or 18 Months Postpartum, Whichever Comes First
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since functional maternal antibody and HIV-envelope binding responses were not a focus of the study.
Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first
Postpartum Component: Pharmacokinetic Parameters of ARV Drugs Measured in Maternal Plasma, Hair, Breast Milk, and Infant Blood (Plasma or Dried Blood Spot) Samples Collected at Birth; Weeks 1, 6, 14, and 26; and Subsequent Visits During Breastfeeding
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since pharmacokinetics was not a focus of the study.
Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first
Postpartum Component: Cost-effectiveness and Feasibility of the Study ARV Prophylaxis Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.
Measured at the end of the 5-year study period
Postpartum Component: Rates and Patterns of Maternal and Infant Resistance to the Maternal and Infant ARV Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.
Measured at the end of the 5-year study period
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
Adherence is by maternal report; adherence through hair analysis is not included here.
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.
Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).
Antepartum Component: Antepartum Change in HBV DNA Viral Load Between Week 8 and Baseline Levels (Using Log HBV DNA) Among Women With Detectable HBV DNA Viral Loads at Baseline and Other HBV Outcome Measures
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since changes in HBV DNA Viral Load was not a focus of the study.
Measured at Week 8
Antepartum Component: Cost Effectiveness and Feasibility of the Trial ARV Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since cost effectiveness was not a focus of the study.
Measured at the end of the 5-year study period
Antepartum Component: Maternal and Infant Viral Resistance to the Maternal and Infant ARV Strategies
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since viral resistance was not a focus of the study.
Measured at the end of the 5-year study period
Antepartum Component: Adherence to the Maternal Antiretroviral (ARV) Regimen, as Measured by Maternal Report
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since adherence was not a focus of the study.
Measured through the Week 1 postpartum study visit
Blantyre
Malawi
Malawi CRS
Lilongwe
Malawi
Soweto IMPAACT CRS
Johannesburg
Gauteng
1862
South Africa
Shandukani Research CRS
Johannesburg
Gauteng
2001
South Africa
Durban Paediatric HIV CRS
Durban
KwaZulu-Natal
4001
South Africa
Umlazi CRS
Durban
KwaZulu-Natal
4001
South Africa
Family Clinical Research Unit (FAM-CRU) CRS
Cape Town
Western Cape
7505
South Africa
Kilimanjaro Christian Medical Centre (KCMC)
Moshi
Tanzania
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala
Uganda
George CRS
Lusaka
Zambia
Seke North CRS
Chitungwiza
Zimbabwe
St Mary's CRS
Chitungwiza
Zimbabwe
Harare Family Care CRS
Harare
Zimbabwe
Result
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. [Updated August 2009]. Available from: http://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf
Result
WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children, World Health Organization, 2007. Available: http://apps.who.int/iris/handle/10665/43699
Bhattacharya D, Tierney C, Butler K, Kiweewa FM, Moodley D, Govender V, Vhembo T, Mohtashemi N, Ship H, Dula D, George K, Chaktoura N, Fowler MG, Peters MG, Currier JS. Comparison of Antiretroviral Therapies in Pregnant Women Living With Human Immunodeficiency Virus and Hepatitis B Virus: A Randomized Controlled Trial. Obstet Gynecol. 2023 Sep 1;142(3):613-624. doi: 10.1097/AOG.0000000000005302. Epub 2023 Aug 3.
Vhembo T, Baltrusaitis K, Tierney C, Owor M, Dadabhai S, Violari A, Theron G, Moodley D, Mukwasi-Kahari C, George K, Shepherd J, Siberry GK, Browning R, Fowler MG, Stranix-Chibanda L; IMPAACT P1084s study team. Bone and Renal Health in Infants With or Without Breastmilk Exposure to Tenofovir-Based Maternal Antiretroviral Treatment in the PROMISE Randomized Trial. J Acquir Immune Defic Syndr. 2023 Aug 15;93(5):431-437. doi: 10.1097/QAI.0000000000003218.
Nevrekar N, Butler K, Shapiro DE, Atuhaire P, Taha TE, Makanani B, Chinula L, Owor M, Moodley D, Chipato T, McCarthy K, Flynn PM, Currier J, Fowler MG, Gupta A, Suryavanshi N. Self-reported Antiretroviral Adherence: Association With Maternal Viral Load Suppression in Postpartum Women Living With HIV-1 From Promoting Maternal and Infant Survival Everywhere, a Randomized Controlled Trial in Sub-Saharan Africa and India. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):76-83. doi: 10.1097/QAI.0000000000003102. Epub 2022 Sep 28.
Fowler MG, Aizire J, Sikorskii A, Atuhaire P, Ogwang LW, Mutebe A, Katumbi C, Maliwichi L, Familiar I, Taha T, Boivin MJ; PROMISE-NEURODEV study team. Growth deficits in antiretroviral and HIV-exposed uninfected versus unexposed children in Malawi and Uganda persist through 60 months of age. AIDS. 2022 Mar 15;36(4):573-582. doi: 10.1097/QAD.0000000000003122.
Stranix-Chibanda L, Tierney C, Pinilla M, George K, Aizire J, Chipoka G, Mallewa M, Naidoo M, Nematadzira T, Kusakara B, Violari A, Mbengeranwa T, Njau B, Fairlie L, Theron G, Mubiana-Mbewe M, Khadse S, Browning R, Fowler MG, Siberry GK; PROMISE Study Team. Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial. PLoS One. 2021 Aug 20;16(8):e0255250. doi: 10.1371/journal.pone.0255250. eCollection 2021.
Theron G, Brummel S, Fairlie L, Pinilla M, McCarthy K, Owor M, Chinula L, Makanani B, Violari A, Moodley D, Chakhtoura N, Browning R, Hoffman R, Fowler MG. Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy. Clin Infect Dis. 2021 Jul 15;73(2):e312-e320. doi: 10.1093/cid/ciaa805.
Aizire J, Sikorskii A, Ogwang LW, Kawalazira R, Mutebe A, Familiar-Lopez I, Mallewa M, Taha T, Boivin MJ, Fowler MG; PROMISE-NEURODEV study team. Decreased growth among antiretroviral drug and HIV-exposed uninfected versus unexposed children in Malawi and Uganda. AIDS. 2020 Feb 1;34(2):215-225. doi: 10.1097/QAD.0000000000002405.
Hoffman RM, Angelidou KN, Brummel SS, Saidi F, Violari A, Dula D, Mave V, Fairlie L, Theron G, Kamateeka M, Chipato T, Chi BH, Stranix-Chibanda L, Nematadzira T, Moodley D, Bhattacharya D, Gupta A, Coletti A, McIntyre JA, Klingman KL, Chakhtoura N, Shapiro DE, Fowler MG, Currier JS; IMPAACT PROMISE 1077BF/FF team. Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial. HIV Clin Trials. 2018 Dec;19(6):209-224. doi: 10.1080/15284336.2018.1537327.
Registrational component to assess entry criteria for possible randomization in the Postpartum Component
FG000855 subjects
FG001861 subjects
FG00225 subjects
FG003129 subjects
Mothers That Met All Inclusion Criteria
FG000853 subjects
FG001861 subjects
FG00224 subjects
FG003129 subjects
COMPLETED
FG000623 subjects
FG001620 subjects
FG00216 subjects
FG003101 subjects
NOT COMPLETED
FG000232 subjects
FG001241 subjects
FG0029 subjects
FG00328 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Death
FG0006 subjects
FG0019 subjects
FG0021 subjects
FG0032 subjects
Withdrawal by Subject
FG00089 subjects
FG00182 subjects
FG0022 subjects
FG00310 subjects
Lost to Follow-up
FG00073 subjects
FG00165 subjects
FG0022 subjects
FG00310 subjects
Site Closure
FG00015 subjects
FG00119 subjects
FG0021 subjects
FG0030 subjects
Subject Unable to Get to Clinic
FG00044 subjects
FG00161 subjects
FG0022 subjects
FG0035 subjects
Other Reason
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0030 subjects
Protocol Version 3.0: 10/2012-10/2014
Type
Comment
Milestone Data
STARTED
FG000694 subjects
FG001686 subjects
FG002422 subjects
FG00375 subjects
Mothers That Met All Inclusion Criteria
FG000694 subjects
FG001684 subjects
FG002421 subjects
FG00375 subjects
COMPLETED
FG000542 subjects
FG001548 subjects
FG002345 subjects
FG00355 subjects
NOT COMPLETED
FG000152 subjects
FG001138 subjects
FG00277 subjects
FG00320 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
All women in 1077BF/1077FF except those considered ineligible for the analysis after team review.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV tail
BG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
BG002
Antepartum Arm C
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
BG003
Late Presenters
Registrational component to assess entry criteria for possible randomization in the Postpartum Component
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001547
BG0011545
BG002445
BG003204
BG0043741
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Inter-Quartile Range
years
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black Non-Hispanic
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Malawi
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Weight
Some late presenters had incomplete measurements
Median
Inter-Quartile Range
kg
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
BMI
Some participants had incomplete measurements for either weight, height, or both.
Median
Inter-Quartile Range
kg/m^2
Title
Denominators
Categories
ParticipantsBG0001545
ParticipantsBG0011535
ParticipantsBG002
HIV RNA level prior to randomization
Baseline HIV RNA data was incomplete for some participants.
Median
Inter-Quartile Range
copies/ml
Title
Denominators
Categories
ParticipantsBG0001540
ParticipantsBG0011542
ParticipantsBG002
Viral Load at enrollment
Baseline HIV RNA data was incomplete for some participants.
Median
Inter-Quartile Range
log10 copies/mL
Title
Denominators
Categories
ParticipantsBG0001540
ParticipantsBG0011542
ParticipantsBG002
CD4 count at screening
Median
Inter-Quartile Range
cells/mm^3
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
ALT (SGPT)
Baseline Alanine Aminotransferase (ALT) values were incomplete for some late presenters.
Median
Inter-Quartile Range
units/liter
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Hemoglobin
Median
Inter-Quartile Range
g/dl
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
WBC
Baseline White Blood Cell (WBC) values were incomplete for some participants.
Median
Inter-Quartile Range
(cells/mm^3)
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Absolute Neutrophil Count at Baseline
Baseline Absolute Neutrophil Count (ANC) values were incomplete for some participants.
Median
Inter-Quartile Range
cells/mm^3
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Platelet count
Baseline platelet counts were incomplete for some participants.
Median
Inter-Quartile Range
cells/mm^3
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011544
ParticipantsBG002
Serum Creatinine
Baseline Serum Creatinine values were incomplete for some participants.
Median
Inter-Quartile Range
mg/dL
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
WHO Clinical Staging of HIV/AIDS
Clinical staging of HIV/AIDS by WHO definitions (WHO, 2007). Staging is based on clinical findings that guide the diagnosis, evaluation, and management of HIV/AIDS. Clinical stages are categorized as 1 through 4, progressing from primary HIV infection to advanced HIV/AIDS. These stages are defined by specific clinical conditions or symptoms as described in the reference.
Baseline WHO staging category was incomplete for some participants.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0001544
ParticipantsBG001
Calculated Creatinine Clearance (ml/min)
Baseline Calculated Creatinine Clearance values were incomplete for some participants
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002
Gestational age at study entry (weeks)
Baseline gestational age was incomplete for some participants.
Median
Inter-Quartile Range
weeks
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011544
ParticipantsBG002
Gestational age at study entry
Baseline gestational age was incomplete for some participants.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0001547
ParticipantsBG0011544
ParticipantsBG002
The Most Complex ARV Regimen for Prior PMTCT
Baseline ARV history data were incomplete for some participants.
Antepartum Component: Number of Confirmed Infant HIV Infections
Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point
Analysis includes data from periods 1 and 2. Analysis is among the live births with HIV test results summarized for the maternal-infant set (the worst outcome summarized for cases of multiple births). Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured at birth or Week 1 study visit
ID
Title
Description
OG000
Antepartum Arm A
Mothers Received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
OG0001386
OG0011385
OG002325
Title
Denominators
Categories
Title
Measurements
OG00025
OG0017
OG0022
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.
Risk Difference (RD)
-1.3
2-Sided
96.5
-2.1
-0.4
The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).
Superiority
Primary
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
Mothers with no safety data available after baseline were not included. Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured through the Week 1 postpartum study visit
ID
Title
Description
OG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
Primary
Antepartum Component: Number of Mothers With Obstetrical Complications
Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as "Pregnancy, puerperium and perinatal conditions", except if the condition was the death of the fetus: "Abortions not specified as induced or spontaneous", "Abortions spontaneous", or "Stillbirth and foetal death."
Mothers who do not have any obstetrical complications information available after study entry are not included. Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured through the Week 1 postpartum study visit
ID
Title
Description
OG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Primary
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
Composite outcome
Includes mothers with confirmed infant birth outcome as live birth, stillbirth, or spontaneous abortion and outcome assessments. Multiple gestation pregnancies (twins and triplets) were summarized at the unique mother level. Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured at birth
ID
Title
Description
OG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
Primary
Postpartum Component: Incidence of Confirmed Infant HIV Infection
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.
All Mother-Infant (M-I) pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 35 M-I pairs with no post-randomization HIV test results were included and censored at the date of randomization in the analyses. Analyses were intent to treat.
Posted
Number
New cases per 100 person-years
Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
ID
Title
Description
OG000
Postpartum Arm A (Maternal Prophylaxis)
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
OG001
Postpartum Arm B (Infant Prophylaxis)
Infants received extended NVP.
Units
Counts
Primary
Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
All mothers were included in the analyses. 15 mothers with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.
Posted
Number
New cases per 100 person-years
Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
ID
Title
Description
OG000
Postpartum Arm A (Maternal Prophylaxis)
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
OG001
Postpartum Arm B (Infant Prophylaxis)
Infants received extended NVP.
Units
Counts
Participants
Primary
Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
OG000
Secondary
Antepartum Component: Number of Infant HIV Infections
Detected by HIV NAT positivity
Analysis is among the live births with HIV test results summarized in the maternal-infant set (the worst outcome summarized for multiple births to the same mother). Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured at the birth (<= 3 days postpartum) visit
ID
Title
Description
OG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
OG000
Secondary
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function.
Infants in the antepartum component not excluded from analysis; only one infant was included per pregnancy, the one with the earliest failure time. The Periods 1&2 group is infants born to mothers randomized in Arms A and B throughout the PROMISE study (both protocol versions). The period 2 group includes infants born to mothers randomized during the last protocol version only. Since Arm C was only available to all under the last protocol version, this enables unbiased comparison with Arm C.
Posted
Number
95% Confidence Interval
Proportional probability
Measured from birth through 104 weeks of age
ID
Title
Description
OG000
Antepartum Arm A
Mothers received ZDV+sdNVP+TRV tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Secondary
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
Analysis used the principle of intent to treat.
Analysis includes only mothers with HIV RNA data at delivery. Analysis used the principle of intent to treat.
Posted
Count of Participants
Participants
Measured at the time of delivery
ID
Title
Description
OG000
Antepartum Arm A
Mothers Received ZDV+sdNVP+TRV Tail
OG001
Antepartum Arm B
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
OG002
Antepartum Arm C
Mothers Received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
OG000
Secondary
Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.
All M-I pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 3 M-I pairs with no post-randomization data were included and censored at the date of randomization. Analyses were intent to treat.
Posted
Number
95% Confidence Interval
Probability
Measured through 24 months post-delivery
ID
Title
Description
OG000
Postpartum Arm A (Maternal Prophylaxis)
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
OG001
Postpartum Arm B (Infant Prophylaxis)
Infants received extended NVP.
Units
Counts
Participants
Secondary
Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair)
All live-born infants were included in the analyses. 4 infants with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.
Posted
Number
95% Confidence Interval
Probability
Measured at 12 and 24 months post-delivery
ID
Title
Description
OG000
Postpartum Arm A (Maternal Prophylaxis)
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
OG001
Postpartum Arm B (Infant Prophylaxis)
Infants received extended NVP.
Units
Counts
Participants
OG000
Secondary
Maternal Health Component: Incidence of Death
Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
OG000
Secondary
Maternal Health Component: Incidence of AIDS-defining Illness
"AIDS-defining illness" refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
OG000
Secondary
Maternal Health Component: Incidence of HIV/AIDS-related Events
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
Secondary
Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events
Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.
Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
events per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Secondary
Maternal Health Component: Other Targeted Medical Conditions
Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
events per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
Secondary
Maternal Health Component: Incidence of HIV/AIDS-related Event or Death
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
Secondary
Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events
"HIV/AIDS-related event" refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
Secondary
Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
events per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Secondary
Maternal Health Component: Incidence of Tuberculosis
Incidence of tuberculosis.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Units
Counts
Participants
OG000
Secondary
Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
New cases per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Maternal Health Arm B (Discontinue Triple ARVs)
Mothers discontinued triple ARV regimen.
Secondary
Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 ("Severe"). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic.
This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.
Posted
Number
95% Confidence Interval
events per 100 person-years
From study entry until July 7, 2015, an average of 94 weeks of follow-up.
ID
Title
Description
OG000
Maternal Health Arm A (Continue Triple ARVs)
Mothers continued receiving triple ARV regimen [preferred regimen: TRV + LPV-RTV].
OG001
Other Pre-specified
Maternal Health Component: Cost-effectiveness
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.
Not Posted
From study entry until July 7, 2015.
Participants
Other Pre-specified
Maternal Health Component: Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since inflammation and thrombogenic markers were not a focus of the study.
Not Posted
From study entry until July 7, 2015.
Participants
Other Pre-specified
Maternal Health Component: Quality of Life
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since quality of life was not a focus of the study.
Not Posted
From study entry until July 7, 2015.
Participants
Other Pre-specified
Maternal Health Component: Self-reported Adherence
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.
Not Posted
From study entry until July 7, 2015.
Participants
Other Pre-specified
Maternal Health Component: Viral Resistance
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.
Not Posted
From study entry until July 7, 2015.
Participants
Other Pre-specified
Postpartum Component: Functional Maternal Antibody and HIV-envelope Binding Responses in Breast Milk and Plasma, Until Cessation of Breastfeeding or 18 Months Postpartum, Whichever Comes First
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since functional maternal antibody and HIV-envelope binding responses were not a focus of the study.
Not Posted
Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first
Participants
Other Pre-specified
Postpartum Component: Pharmacokinetic Parameters of ARV Drugs Measured in Maternal Plasma, Hair, Breast Milk, and Infant Blood (Plasma or Dried Blood Spot) Samples Collected at Birth; Weeks 1, 6, 14, and 26; and Subsequent Visits During Breastfeeding
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since pharmacokinetics was not a focus of the study.
Not Posted
Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first
Participants
Other Pre-specified
Postpartum Component: Cost-effectiveness and Feasibility of the Study ARV Prophylaxis Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since cost-effectiveness was not a focus of the study.
Not Posted
Measured at the end of the 5-year study period
Participants
Other Pre-specified
Postpartum Component: Rates and Patterns of Maternal and Infant Resistance to the Maternal and Infant ARV Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since viral resistance was not a focus of the study.
Not Posted
Measured at the end of the 5-year study period
Participants
Other Pre-specified
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
Adherence is by maternal report; adherence through hair analysis is not included here.
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study.
Women or infants in the postpartum component who had been included in the primary efficacy analysis (outcome measure #5 above), i.e., who had not yet reached the site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first, and whose adherence questionnaire was filled out.
Posted
Count of Participants
Participants
Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).
ID
Title
Description
OG000
Postpartum Arm A (Maternal Prophylaxis)
Mothers received prophylaxis [preferred regimen: TRV + LPV-RTV]. Infants received short-course NVP.
OG001
Postpartum Arm B (Infant Prophylaxis)
Infants received extended NVP.
Other Pre-specified
Antepartum Component: Antepartum Change in HBV DNA Viral Load Between Week 8 and Baseline Levels (Using Log HBV DNA) Among Women With Detectable HBV DNA Viral Loads at Baseline and Other HBV Outcome Measures
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since changes in HBV DNA Viral Load was not a focus of the study.
Not Posted
Measured at Week 8
Participants
Other Pre-specified
Antepartum Component: Cost Effectiveness and Feasibility of the Trial ARV Regimens
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since cost effectiveness was not a focus of the study.
Not Posted
Measured at the end of the 5-year study period
Participants
Other Pre-specified
Antepartum Component: Maternal and Infant Viral Resistance to the Maternal and Infant ARV Strategies
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since viral resistance was not a focus of the study.
Not Posted
Measured at the end of the 5-year study period
Participants
Other Pre-specified
Antepartum Component: Adherence to the Maternal Antiretroviral (ARV) Regimen, as Measured by Maternal Report
The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome measure since adherence was not a focus of the study.
Not Posted
Measured through the Week 1 postpartum study visit
Participants
Time Frame
From study entry (for mothers) or birth (for infants) until study completion on September 30, 2016, an average of 169 weeks for mothers and through 24 months or September 30, 2016 for infants, whichever came first.
Description
Some women lost their infant before delivery. Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the DAIDS AE Grading Table, Version 1.0, 2009, available on the RSC website (http://rsc.tech-res.com).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Mother, (AP) ZDV+sdNVP+TRV Tail
Mothers received ZDV+sdNVP+TRV tail
9
1,547
267
1,547
1,413
1,547
EG001
Mother, (AP) Triple ARV (3TC-ZDV/LPV-RTV)
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
14
1,545
276
1,545
1,414
1,545
EG002
Mother, (AP) Triple ARV (FTC-TDF/LPV-RTV)
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
2
445
69
445
388
445
EG003
Mother, LP
Registrational component to assess entry criteria for possible randomization in the Postpartum Component
3
204
10
204
169
204
EG004
Infant, (Mother Received ZDV+sdNVP+TRV Tail)
Mothers received ZDV+sdNVP+TRV tail
59
1,500
296
1,500
1,406
1,500
EG005
Infant, (Mother Received Triple ARV (3TC-ZDV/LPV-RTV))
Mothers received Triple ARV (3TC-ZDV/LPV-RTV)
46
1,478
287
1,478
1,388
1,478
EG006
Infant, (Mother Received Triple ARV (FTC-TDF/LPV-RTV))
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
27
429
113
429
403
429
EG007
Infant, LP
Registrational component to assess entry criteria for possible randomization in the Postpartum Component
5
204
20
204
170
204
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG00013 affected1,547 at risk
EG00116 affected1,545 at risk
EG0024 affected445 at risk
EG0033 affected204 at risk
EG00410 affected1,500 at risk
EG00511 affected1,478 at risk
EG0060 affected429 at risk
EG0070 affected204 at risk
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pulmonary valve stenosis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Atrial septal defect
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cleft palate
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital anaemia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital anomaly
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital genital malformation male
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital inguinal hernia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital malaria
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital megacolon
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital musculoskeletal anomaly
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital pneumonia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital rubella infection
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital syphilis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Congenital umbilical hernia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Craniosynostosis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Dermoid cyst
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Exomphalos
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Gastroschisis
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Genitalia external ambiguous
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Heart disease congenital
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Holoprosencephaly
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypospadias
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Laryngomalacia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Macrocephaly
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningomyelocele
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Micrognathia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Multiple congenital abnormalities
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Multiple gastrointestinal atresias
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Persistent foetal circulation
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Sickle cell anaemia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Talipes
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Trisomy 21
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cataract
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Strabismus
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Femoral hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Necrotising colitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0021 affected445 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0021 affected445 at risk
EG003
Death
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Sudden infant death syndrome
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Brain abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bronchiolitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bullous impetigo
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Dysentery
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Enterobacter sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 affected1,547 at risk
EG00110 affected1,545 at risk
EG0021 affected445 at risk
EG003
Giardiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Malaria
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0009 affected1,547 at risk
EG0016 affected1,545 at risk
EG0024 affected445 at risk
EG003
Measles
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningitis cryptococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningitis tuberculous
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neonatal pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ophthalmia neonatorum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Pelvic infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Pertussis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Plasmodium falciparum infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 affected1,547 at risk
EG0012 affected1,545 at risk
EG0021 affected445 at risk
EG003
Plasmodium malariae infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0015 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0014 affected1,545 at risk
EG0020 affected445 at risk
EG003
Post procedural sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0021 affected445 at risk
EG003
Postpartum sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0012 affected1,545 at risk
EG0021 affected445 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Salmonella sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Salpingitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Sexually transmitted disease
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Staphylococcal scalded skin syndrome
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00012 affected1,547 at risk
EG0018 affected1,545 at risk
EG0024 affected445 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vulvovaginitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vulvovaginitis trichomonal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Wound infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0021 affected445 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abdominal wound dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Bladder injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Burns first degree
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Herbal toxicity
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Penetrating abdominal trauma
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Uterine dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Uterine rupture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vaginal laceration
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0015 affected1,545 at risk
EG0020 affected445 at risk
EG003
Amniotic fluid volume decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0014 affected1,545 at risk
EG0020 affected445 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Foetal non-stress test abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Liver function test increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypoglycaemia neonatal
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Marasmus
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Poor feeding infant
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vitamin K deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Joint hyperextension
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Symphysiolysis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Convulsion neonatal
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Encephalopathy neonatal
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion complete
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0004 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0007 affected1,547 at risk
EG0015 affected1,545 at risk
EG0021 affected445 at risk
EG003
Abortion threatened
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0011 affected1,545 at risk
EG0022 affected445 at risk
EG003
Eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0022 affected445 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
False labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0014 affected1,545 at risk
EG0020 affected445 at risk
EG003
Foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00025 affected1,547 at risk
EG00137 affected1,545 at risk
EG0027 affected445 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0005 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Foetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00018 affected1,547 at risk
EG0019 affected1,545 at risk
EG0026 affected445 at risk
EG003
HELLP syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Haemorrhage in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0009 affected1,547 at risk
EG0014 affected1,545 at risk
EG0021 affected445 at risk
EG003
Hyperemesis gravidarum
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0021 affected445 at risk
EG003
Intrapartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Labour pain
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meconium in amniotic fluid
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Obstructed labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0014 affected1,545 at risk
EG0022 affected445 at risk
EG003
Peripartum cardiomyopathy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Placenta accreta
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Placenta praevia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Placental insufficiency
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Polyhydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00011 affected1,547 at risk
EG00111 affected1,545 at risk
EG0022 affected445 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00015 affected1,547 at risk
EG00116 affected1,545 at risk
EG0023 affected445 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0009 affected1,547 at risk
EG0014 affected1,545 at risk
EG0023 affected445 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00016 affected1,547 at risk
EG00115 affected1,545 at risk
EG0028 affected445 at risk
EG003
Premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG00010 affected1,547 at risk
EG00114 affected1,545 at risk
EG0022 affected445 at risk
EG003
Premature separation of placenta
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0006 affected1,547 at risk
EG0012 affected1,545 at risk
EG0022 affected445 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0007 affected1,547 at risk
EG0014 affected1,545 at risk
EG0023 affected445 at risk
EG003
Prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Prolonged pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Retained placenta or membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Retained products of conception
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0006 affected1,547 at risk
EG0014 affected1,545 at risk
EG0022 affected445 at risk
EG003
Ruptured ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Small for dates baby
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0005 affected1,547 at risk
EG0019 affected1,545 at risk
EG0021 affected445 at risk
EG003
Threatened labour
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0014 affected1,545 at risk
EG0020 affected445 at risk
EG003
Umbilical cord around neck
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Umbilical cord prolapse
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Umbilical granuloma
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vomiting in pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Brief psychotic disorder, with postpartum onset
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Intentional self-injury
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0014 affected1,545 at risk
EG0020 affected445 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0012 affected1,545 at risk
EG0020 affected445 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Adnexa uteri mass
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Cervix disorder
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Uterine atony
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Vulval haemorrhage
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Allergic respiratory disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Respiratory depression
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Umbilical haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Acrochordon excision
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Infection prophylaxis
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Psychosocial support
Surgical and medical procedures
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0011 affected1,545 at risk
EG0020 affected445 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0002 affected1,547 at risk
EG0010 affected1,545 at risk
EG0021 affected445 at risk
EG003
Haematoma
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0006 affected1,547 at risk
EG0013 affected1,545 at risk
EG0020 affected445 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0001 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Subgaleal haematoma
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG00034 affected1,547 at risk
EG00133 affected1,545 at risk
EG0023 affected445 at risk
EG00310 affected204 at risk
EG00496 affected1,500 at risk
EG00581 affected1,478 at risk
EG0066 affected429 at risk
EG00718 affected204 at risk
Congenital umbilical hernia
Congenital, familial and genetic disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Eye discharge
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0007 affected1,547 at risk
EG0016 affected1,545 at risk
EG0022 affected445 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG000167 affected1,547 at risk
EG001164 affected1,545 at risk
EG00221 affected445 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG000179 affected1,547 at risk
EG001202 affected1,545 at risk
EG00241 affected445 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00072 affected1,547 at risk
EG00163 affected1,545 at risk
EG00224 affected445 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00081 affected1,547 at risk
EG00190 affected1,545 at risk
EG00219 affected445 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG000118 affected1,547 at risk
EG00192 affected1,545 at risk
EG00226 affected445 at risk
EG003
Body tinea
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00081 affected1,547 at risk
EG00184 affected1,545 at risk
EG00218 affected445 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00037 affected1,547 at risk
EG00130 affected1,545 at risk
EG00210 affected445 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG000111 affected1,547 at risk
EG001101 affected1,545 at risk
EG00225 affected445 at risk
EG003
Malaria
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00085 affected1,547 at risk
EG00179 affected1,545 at risk
EG00217 affected445 at risk
EG003
Ophthalmia neonatorum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00013 affected1,547 at risk
EG0018 affected1,545 at risk
EG0020 affected445 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00010 affected1,547 at risk
EG00111 affected1,545 at risk
EG0028 affected445 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00088 affected1,547 at risk
EG00192 affected1,545 at risk
EG00221 affected445 at risk
EG003
Plasmodium falciparum infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00070 affected1,547 at risk
EG00175 affected1,545 at risk
EG00214 affected445 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00018 affected1,547 at risk
EG00125 affected1,545 at risk
EG0022 affected445 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG000177 affected1,547 at risk
EG001154 affected1,545 at risk
EG00252 affected445 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG000229 affected1,547 at risk
EG001206 affected1,545 at risk
EG00268 affected445 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG000470 affected1,547 at risk
EG001493 affected1,545 at risk
EG002116 affected445 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG00068 affected1,547 at risk
EG00188 affected1,545 at risk
EG00229 affected445 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG00061 affected1,547 at risk
EG00185 affected1,545 at risk
EG00250 affected445 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG000764 affected1,547 at risk
EG001791 affected1,545 at risk
EG002191 affected445 at risk
EG003
Hormone level abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG00025 affected1,547 at risk
EG00130 affected1,545 at risk
EG00211 affected445 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG000668 affected1,547 at risk
EG001619 affected1,545 at risk
EG002161 affected445 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG000151 affected1,547 at risk
EG001144 affected1,545 at risk
EG00241 affected445 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG000112 affected1,547 at risk
EG00185 affected1,545 at risk
EG00221 affected445 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG00066 affected1,547 at risk
EG00154 affected1,545 at risk
EG00215 affected445 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Growth failure
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 affected1,547 at risk
EG0010 affected1,545 at risk
EG0020 affected445 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG000189 affected1,547 at risk
EG001188 affected1,545 at risk
EG00223 affected445 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG000272 affected1,547 at risk
EG001271 affected1,545 at risk
EG00252 affected445 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG00080 affected1,547 at risk
EG00178 affected1,545 at risk
EG0029 affected445 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG000116 affected1,547 at risk
EG001136 affected1,545 at risk
EG00221 affected445 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG000179 affected1,547 at risk
EG001173 affected1,545 at risk
EG00220 affected445 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00020 affected1,547 at risk
EG00113 affected1,545 at risk
EG0022 affected445 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00081 affected1,547 at risk
EG00193 affected1,545 at risk
EG00212 affected445 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00064 affected1,547 at risk
EG00169 affected1,545 at risk
EG0028 affected445 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG00035 affected1,547 at risk
EG00131 affected1,545 at risk
EG0022 affected445 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG000119 affected1,547 at risk
EG001120 affected1,545 at risk
EG00227 affected445 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Point of Contact
Title
Organization
Phone
Extension
Email
IMPAACT Clinicaltrials.gov Coordinator
Family Health International (FHI 360)
(919) 405-1429
IMPAACT.ctgov@fstrf.org
ID
Term
D015658
HIV Infections
D001942
Breast Feeding
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
D005247
Feeding Behavior
D001519
Behavior
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D015215
Zidovudine
D019829
Nevirapine
D000069480
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
C109078
lamivudine, zidovudine drug combination
D061466
Lopinavir
Ancestor Terms
ID
Term
D013936
Thymidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D015224
Dideoxynucleosides
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D011725
Pyridines
D000068698
Tenofovir
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D000068679
Emtricitabine
D003841
Deoxycytidine
D003562
Cytidine
D000225
Adenine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D004338
Drug Combinations
D004364
Pharmaceutical Preparations
D011744
Pyrimidinones
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Death
FG0003 subjects
FG0015 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG00054 subjects
FG00152 subjects
FG00231 subjects
FG0033 subjects
Lost to Follow-up
FG00049 subjects
FG00136 subjects
FG00225 subjects
FG0034 subjects
Site Closure
FG00012 subjects
FG00111 subjects
FG0022 subjects
FG0030 subjects
Subject Unable to Get to Clinic
FG00028 subjects
FG00126 subjects
FG00215 subjects
FG0035 subjects
Other Reason
FG0005 subjects
FG0018 subjects
FG0021 subjects
FG0033 subjects
204
ParticipantsBG0043741
Title
Measurements
BG00026.5(22.8 to 30.1)
BG00126.6(23.3 to 30.3)
BG00226.4(22.7 to 30.4)
BG00326.8(23.2 to 31.1)
BG00426.5(23.0 to 30.3)
445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
Female
BG0001547
BG0011545
BG002445
BG003204
BG0043741
Male
BG0000
BG0010
BG0020
BG0030
BG004
445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG0001493
BG0011487
BG002440
BG003183
BG0043603
Hispanic (Regardless of Race)
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG0007
BG00112
BG0024
BG003
Asian, Pacific Islander
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG00047
BG00146
BG0021
BG003
445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG000489
BG001493
BG002155
BG00331
BG0041168
Tanzania
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG00023
BG00124
BG00210
BG003
South Africa
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG000513
BG001510
BG00278
BG003
Uganda
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG000207
BG001205
BG00285
BG003
Zimbabwe
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG000237
BG001236
BG00299
BG003
Zambia
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG00032
BG00131
BG00218
BG003
India
ParticipantsBG0001547
ParticipantsBG0011545
ParticipantsBG002445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG00046
BG00146
BG0020
BG003
445
ParticipantsBG003200
ParticipantsBG0043737
Title
Measurements
BG00064(57.5 to 73.5)
BG00164.6(58 to 74.1)
BG00264.4(58 to 75.9)
BG00360.9(53 to 68.9)
BG00464(57.5 to 74)
442
ParticipantsBG003198
ParticipantsBG0043720
Title
Measurements
BG00025.9(23.5 to 29.5)
BG00126.3(23.4 to 29.8)
BG00226.3(23.5 to 30.1)
BG00323.6(21.8 to 26.8)
BG00426(23.4 to 29.6)
445
ParticipantsBG003196
ParticipantsBG0043723
Title
Measurements
BG0006409(1450.5 to 22720)
BG0018002(1854 to 28767)
BG0028393(1909 to 28454)
BG00312140(2407.5 to 39138.5)
BG0047409(1708 to 26350)
445
ParticipantsBG003196
ParticipantsBG0043723
Title
Measurements
BG0003.8(3.2 to 4.4)
BG0013.9(3.3 to 4.5)
BG0023.9(3.3 to 4.5)
BG0034.1(3.4 to 4.6)
BG0043.9(3.2 to 4.4)
445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG000534(435 to 678)
BG001526(439 to 651)
BG002538(434 to 684)
BG003520(353 to 723)
BG004530(434 to 670)
445
ParticipantsBG003196
ParticipantsBG0043733
Title
Measurements
BG00012(10 to 16)
BG00112(9 to 15)
BG00212(9 to 15)
BG00316.5(12 to 22)
BG00412(10 to 16)
445
ParticipantsBG003204
ParticipantsBG0043741
Title
Measurements
BG00011(10.2 to 11.8)
BG00111.1(10.3 to 11.8)
BG00211(10.3 to 11.8)
BG00310.6(9.5 to 11.7)
BG00411(10.2 to 11.8)
445
ParticipantsBG003196
ParticipantsBG0043733
Title
Measurements
BG0006800(5670 to 8200)
BG0016900(5700 to 8200)
BG0026840(5700 to 7900)
BG0038660(6895 to 10755)
BG0046900(5700 to 8250)
445
ParticipantsBG003196
ParticipantsBG0043733
Title
Measurements
BG0004140(3250 to 5360)
BG0014209(3297 to 5300)
BG0023990(3220 to 4990)
BG0035680(4342.5 to 7662.5)
BG0044220(3297 to 5400)
444
ParticipantsBG003195
ParticipantsBG0043730
Title
Measurements
BG000238000(200000 to 282000)
BG001236000(196000 to 282000)
BG002242500(203000 to 290000)
BG003255000(217000 to 321000)
BG004239000(200000 to 285000)
445
ParticipantsBG003199
ParticipantsBG0043736
Title
Measurements
BG0000.5(0.4 to 0.6)
BG0010.5(0.4 to 0.6)
BG0020.5(0.4 to 0.6)
BG0030.6(0.5 to 0.6)
BG0040.5(0.4 to 0.6)
1542
ParticipantsBG002445
ParticipantsBG003169
ParticipantsBG0043700
Title
Measurements
Clinical stage I
BG0001493
BG0011506
BG002434
BG003165
BG0043598
Clinical stage II
BG00050
BG00134
BG00211
BG0034
BG004
Clinical stage III
BG0001
BG0012
BG0020
BG0030
BG004
445
ParticipantsBG003199
ParticipantsBG0043736
Title
Measurements
<= 50 ml/min
BG0000
BG0010
BG0020
BG0031
BG0041
> 50 - 60 ml/min
BG0001
BG0010
BG0021
BG0031
BG004
> 60 - 80 ml/min
BG0005
BG0015
BG0022
BG0032
BG004
> 80 - 100 ml/min
BG00027
BG00131
BG0026
BG00310
BG004
> 100 - 120 ml/min
BG00090
BG001108
BG00239
BG00331
BG004
> 120 ml/min
BG0001424
BG0011401
BG002397
BG003154
BG004
445
ParticipantsBG003194
ParticipantsBG0043730
Title
Measurements
BG00025.7(20.9 to 30.3)
BG00125.2(20.6 to 30.1)
BG00226(21.9 to 31.1)
BG00338.6(37.3 to 40)
BG00425.6(21.1 to 30.4)
445
ParticipantsBG00310
ParticipantsBG0043546
Title
Measurements
<14 weeks
BG00010
BG0018
BG0022
BG0030
BG00420
14 - <28 weeks
BG000956
BG0011008
BG002264
BG0030
BG004
28 - <34 weeks
BG000418
BG001368
BG002116
BG0031
BG004
34 - < 37 weeks
BG000117
BG001113
BG00245
BG0030
BG004
>= 37 weeks
BG00046
BG00147
BG00218
BG0039
BG004
445
ParticipantsBG003204
ParticipantsBG0043732
Title
Measurements
HAART including NNRTI
BG0007
BG0015
BG0022
BG0030
BG00414
sdNVP+ZDV
BG00033
BG00148
BG0026
BG0030
BG004
sdNVP
BG00041
BG00146
BG00215
BG0032
BG004
One PI
BG0000
BG0011
BG0020
BG0030
BG004
One NRTI
BG0002
BG0012
BG0020
BG0030
BG004
No ARVs for prior PMTCT/no prior pregnancy
BG0001456
BG0011442
BG002422
BG003202
BG004
445
ParticipantsBG003204
ParticipantsBG0043732
Title
Measurements
HAART including NNRTI
BG0001
BG0011
BG0020
BG0037
BG0049
Two NRTIs
BG0002
BG0015
BG0023
BG00310
BG004
sdNVP+ZDV
BG0002
BG0010
BG0020
BG0031
BG004
sdNVP
BG0005
BG0012
BG0020
BG00333
BG004
One NRTI
BG000326
BG001336
BG002125
BG0030
BG004
No ARVs during the current pregnancy
BG0001203
BG0011200
BG002317
BG003153
BG004
OG0001521
OG0011520
OG002424
Title
Denominators
Categories
Periods 1 and 2
ParticipantsOG0001510
ParticipantsOG0011505
ParticipantsOG0020
Title
Measurements
OG000261
OG001318
Period 2
ParticipantsOG000393
ParticipantsOG001385
ParticipantsOG002380
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Periods 1 and 2
Fisher Exact
0.008
Superiority
OG000
OG002
Period 2
Fisher Exact
0.77
Superiority
OG001
OG002
Period 2
Fisher Exact
>0.99
Superiority
Units
Counts
Participants
OG0001521
OG0011520
OG002424
Title
Denominators
Categories
Periods 1 and 2
ParticipantsOG0001521
ParticipantsOG0011510
ParticipantsOG0020
Title
Measurements
OG00089
OG00175
Period 2
ParticipantsOG000401
ParticipantsOG001398
ParticipantsOG002391
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Periods 1 and 2
Fisher Exact
0.30
Superiority
OG000
OG002
Period 2
Fisher Exact
0.64
Superiority
OG001
OG002
Period 2
Fisher Exact
0.06
Superiority
OG0001451
OG0011447
OG002372
Title
Denominators
Categories
Periods 1 and 2
ParticipantsOG0001451
ParticipantsOG0011447
ParticipantsOG0020
Title
Measurements
OG000389
OG001563
Period 2
ParticipantsOG000349
ParticipantsOG001348
ParticipantsOG002341
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Periods 1 and 2
Fisher Exact
<0.001
Superiority
OG000
OG002
Period 2
Fisher Exact
0.04
Superiority
OG001
OG002
Period 2
Fisher Exact
0.46
Superiority
Participants
OG0001219
OG0011211
Title
Denominators
Categories
Title
Measurements
OG0000.56
OG0010.55
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Hazard Ratio (HR)
1.0
2-Sided
96
0.3
3.1
The confidence interval was based on a repeated confidence interval.
Superiority
OG0001220
OG0011211
Title
Denominators
Categories
Title
Measurements
OG00014.4
OG00114.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.98
Superiority
797
OG001805
Title
Denominators
Categories
Title
Measurements
OG0000.24
OG0010.49
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.37
Hazard Ratio (HR)
0.55
2-Sided
95
0.14
2.08
The hazard ratio compares Arm A relative to Arm B.
Superiority
1386
OG0011385
OG002325
Title
Denominators
Categories
Title
Measurements
OG00022
OG0014
OG0022
Mothers received Triple ARV (FTC-TDF/LPV-RTV)
Units
Counts
Participants
OG0001475
OG0011459
OG002389
Title
Denominators
Categories
Overall survival, Periods 1 & 2 group (arms A & B only)
ParticipantsOG0001475
ParticipantsOG0011459
ParticipantsOG0020
Title
Measurements
OG0000.959(0.948 to 0.969)
OG0010.967(0.955 to 0.975)
Overall survival, period 2 group
ParticipantsOG000404
ParticipantsOG001399
ParticipantsOG002389
Title
Measurements
OG000
HIV-free survival, Periods 1&2 group (arms A&B only)