Evaluating the Safety of Immediate Versus Deferred Isonia... | NCT01494038

ID	Type	Description	Link
10732	Registry Identifier	DAIDS ES
IMPAACT P1078

Label	Type	Description	Intervention Names
Arm A (Immediate INH Treatment)	Experimental	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum.	Drug: Isoniazid (INH) Drug: Placebo for isoniazid (INH)
Arm B (Deferred INH Treatment)	Experimental	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.	Drug: Isoniazid (INH) Drug: Placebo for isoniazid (INH)

Name	Type	Description	Arm Group Labels	Other Names
Isoniazid (INH)	Drug	300-mg tablet once daily by mouth, either from entry through Week 28 antepartum (Arm A) or from Week 12 postpartum through Week 40 postpartum (Arm B)	Arm A (Immediate INH Treatment)

Measure	Description	Time Frame
Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment	Incidence rate, calculated by Mantel-Haenszel (MH), weighted by gestational age strata 1) gestational age at entry less than 24 weeks or 2) gestational age at entry greater than or equal to 24 weeks. AE's include laboratory results, signs/symptoms, or diagnoses; graded as per Division of AIDS (DAIDS) or by protocol-defined hepatotoxicity measures. Related to treatment indicates possibly, probably, or definitely related to INH or Placebo for INH as judged by Independent Endpoint Review Committee. Discontinuation refers to permanent discontinuation of study treatment.	Measured from study entry through Week 48 after birth

Measure	Description	Time Frame
Number of Mothers With a Fetal Death	Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death	Measured from study entry through end of pregnancy
Number of Mothers With a Fetus Small for Gestational Age

Name	Affiliation	Role
Amita Gupta, MD, MHS	Johns Hopkins University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Gaborone CRS		Gaborone			Botswana
Molepolole CRS

PubMed Identifier	Type	Citation	Retractions
20091503	Background	Akolo C, Adetifa I, Shepperd S, Volmink J. Treatment of latent tuberculosis infection in HIV infected persons. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000171. doi: 10.1002/14651858.CD000171.pub3.
17085459	Background	Zar HJ, Cotton MF, Strauss S, Karpakis J, Hussey G, Schaaf HS, Rabie H, Lombard CJ. Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial. BMJ. 2007 Jan 20;334(7585):136. doi: 10.1136/bmj.39000.486400.55. Epub 2006 Nov 3.

Label	URL
Manual for Expedited Reporting of Adverse Events to Division of AIDS (DAIDS), Version 2.0, January 2010	View source

ID	Title	Description
FG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2015	Sep 6, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment

Incidence rate, calculated by Mantel-Haenszel (MH), weighted by gestational age strata 1) gestational age at entry less than 24 weeks or 2) gestational age at entry greater than or equal to 24 weeks. AE's include laboratory results, signs/symptoms, or diagnoses; graded as per Division of AIDS (DAIDS) or by protocol-defined hepatotoxicity measures. Related to treatment indicates possibly, probably, or definitely related to INH or Placebo for INH as judged by Independent Endpoint Review Committee. Discontinuation refers to permanent discontinuation of study treatment.

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts
Participants	OG000477 OG001479

Title

Denominators

Categories

Title	Measurements
	OG00015.03 OG00114.93

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						Incidence rate difference	0.10			2-Sided	95	-4.77	4.98					Non-Inferiority	Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.

Secondary

Number of Mothers With a Fetal Death

Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death

Mothers who had at least one live birth, stillbirth, or spontaneous abortion. One participant with outcome of induced abortion not included

Posted

Count of Participants

Participants

Measured from study entry through end of pregnancy

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Number of Mothers With a Fetus Small for Gestational Age

Small for gestational age was determined by physician at site

Measurement of small-for-gestational-age was deemed to be unreliable. Analysis not performed.

Posted

Measured at delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Number of Mothers With an Infant Born Prematurely

Premature birth is defined as gestational age of < 37 weeks at delivery.

Mothers who had at least one live birth

Posted

Count of Participants

Participants

Measured at delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Number of Mothers With a Low Birth-weight Infant

Low birth weight is defined as weight < 2500 mg

Mothers who had at least one live birth available to be weighed at time of delivery

Posted

Count of Participants

Participants

Measured on day of birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Number of Mothers With an Infant With a Congenital Anomaly

Includes congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria.

Mothers who had at least one live birth able to be assessed between birth and 48 weeks after birth

Posted

Count of Participants

Participants

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Number of Mothers With an Adverse Pregnancy Outcome: Spontaneous Abortion, Stillbirth, Premature Birth, Low Birth Weight, or Congenital Anomaly

In case of a multiple birth, mothers who had at least one adverse pregnancy outcome. Spontaneous abortion is intra-uterine fetal death prior to 20 weeks of gestational age; stillbirth, the same, >= 20 weeks; preterm delivery, < 37 weeks of gestational age; low birth weight, < 2,500 grams, and congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria.

Mothers who had at least one live birth, stillbirth, or spontaneous abortion; participant with induced abortion is omitted, and whose babies were available for examination after birth (if born alive)

Posted

Count of Participants

Participants

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit

Secondary

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE

Laboratory, sign/symptom, or diagnoses graded as 3 or higher by DAIDS criteria.

Infants born alive

Posted

Count of Participants

Participants

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment

As before, but AE is judged to be possibly, probably, or definitely related to INH or Placebo for INH, by clinic medical staff

Infants born alive

Posted

Count of Participants

Participants

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Number of Infants Which Are HIV-infected

HIV infection determined during follow-up period. Infection at birth or during breastfeeding

Infants born alive

Posted

Count of Participants

Participants

Measured from study entry through study Week 44

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Number of Infants Hospitalized

Hospitalization due to reasons other than birth

Infants born alive

Posted

Count of Participants

Participants

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Incidence Rate of TB Infection Among Mothers

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB infection, as judged by Secondary Endpoint Review Committee

All participants enrolled without active TB at entry

Posted

Number

events per 100 person-years

Measured from study entry to Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate of Tuberculosis (TB) Among Infants

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB, or congenital TB as defined using the Cantwell criteria (see reference), judged by the Secondary Endpoint Review Committee. Includes an infant death due to unknown cause.

Live-born infants of enrolled women

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate of Infant Death

Incidence rate was calculated by Mantel-Haenszel, weighted by gestational age strata.

Live-born infants of enrolled women

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Incidence Rate of Maternal Deaths

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

All participants enrolled without active TB at entry

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Incidence Rate of Combined Endpoints: Maternal TB or Maternal Death

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

All participants enrolled without active TB at entry.

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate of Combined Endpoints: Infant TB or Infant Death

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

Live-born infants of enrolled women

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Incidence Rate of Combined Endpoints: Maternal TB, Maternal Death, Infant TB, or Infant Death

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

Number of mother-infant pairs with at least one infant live birth and in which mother did not have active TB at entry.

Posted

Number

events per 100 person-years

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate of Combined Endpoint, Antepartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through end of pregnancy

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate of Combined Endpoint, up to 12 Weeks Postpartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through 12 weeks after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate, Antepartum, of Grade 3 or Higher AE

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through end of pregnancy

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Incidence Rate, up to 12 Weeks Postpartum, of Grade 3 or Higher AE

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through 12 weeks postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by Protocol-specific Definition of Hepatotoxicity, Related to Treatment

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. Protocol-specific definition of hepatotoxicity: Any one of the following: 1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of normal (ULN), where ULN is specified by the clinic physician; 2) Total bilirubin > 3 X ULN; 3) ALT greater than 3 X ULN and total bilirubin greater than 2 X ULN; or 4) ALT > 3 X ULN and persistent symptomatic clinical hepatitis

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Related to Treatment

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through 12 weeks postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit

Secondary

Incidence Rate, Antepartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.

All women enrolled.

Posted

Number

events per 100 person-years

Measured from study entry through delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.

All women enrolled

Posted

Number

events per 100 person-years

Measured from study entry through 12 weeks postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Hepatotoxicity definition as defined by DAIDS AE grading criteria 1.0.

All women.

Posted

Number

events per 100 person-years

Measured from study entry through delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata

All women

Posted

Number

events per 100 person-years

Measured from study start through 12 weeks postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.

All women

Posted

Number

events per 100 person-years

Measured from study entry through delivery

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Any Cause

Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.

All women.

Posted

Number

events per 100 person-years

Measured from study start through 12 weeks postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units

Secondary

Number of Mothers With Tuberculosis Resistant to INH

Resistance to INH from isolates of Mycobacterium tuberculosis, as a percentage of mothers who develop culture-confirmed TB

Mothers with culture-confirmed TB

Posted

Count of Participants

Participants

Measured from study entry through Week 48 postpartum

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Secondary

Number of Infants With Tuberculosis Resistant to INH

Resistance to INH from isolates of Mycobacterium tuberculosis, as a percentage of infants who develop culture-confirmed TB

No infants had culture-confirmed TB

Posted

Measured from study entry through Week 48 after birth

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.

Units	Counts

Secondary

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve of Plasma Concentration Versus Time (AUC24h), for INH

Pharmacokinetic parameter was estimated from population PK modeling fitted to the intensive PK data. AUC0-24h was predicted using population pharmacokinetic model using the NONMEM software program. A 2-compartment model with first-order absorption with transit compartment and first-order elimination with well-stirred liver model to capture hepatic clearance and first-pass extraction with 1 parameter (hepatic intrinsic clearance) was used,

Participants with intensive pharmacokinetic results while on active INH, who were established on INH.

Posted

Mean

95% Confidence Interval

hour*mg/L

Measured at antepartum (third trimester and >= 2 weeks after starting study drug) and week 16 postpartum (+/-) 4 weeks) while on active INH; blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dosing.

ID	Title	Description
OG000	Fast Metabolizers	Those women having a genotype of fast INH metabolism.
OG001	Intermediate Metabolizers	Those women having a genotype of intermediate INH metabolism.
OG002	Slow Metabolizers	Those women having a genotype of slow INH metabolism.

Secondary

Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve (AUC24h), for EFV

Participants with intensive pharmacokinetic results while on active EFV and who were stabled on EFV-based ART.

Posted

Mean

95% Confidence Interval

hour*mg/L

ID	Title	Description
OG000	Fast Metabolizers	Those women with a phenotype of fast EFV metabolism.
OG001	Intermediate Metabolizers	Those women with a phenotype of intermediate EFV metabolism.
OG002	Slow Metabolizers	Those women with a phenotype of slow EFV metabolism.

Secondary

Agreement Between Interferon-gamma Release Assay (IGRA) TB Test and Tuberculin Skin Test (TST) Results, Women at Delivery

IGRA done by Quantiferon Gold Test (QGIT). For women, TST is considered positive if greater than or equal to 5 mm

Women tested for tuberculosis infection at delivery

Posted

Count of Participants

Participants

Measured at delivery

ID	Title	Description
OG000	Positive IGRA TB Test	Women who had positive IGRA TB test at delivery
OG001	Negative IGRA TB Test	Women who had negative IGRA TB test at delivery

Units	Counts
Participants	OG000

Secondary

Agreement Between IGRA and TST TB Test Results, Infant

The TST result was positive if greater than or equal to 10 mm in HIV-negative infants, or greater than or equal to 5 mm in HIV-positive infants.

Infants with tuberculin tests performed at week 44 postpartum

Posted

Count of Participants

Participants

Measured at week 44 after birth

ID	Title	Description
OG000	Positive IGRA Test	Infants with positive IGRA test at week 44 postpartum
OG001	Negative IGRA Tuberculin Test	Infants with a negative IGRA test at 44 weeks postpartum

Units	Counts
Participants	OG000

Secondary

Agreement Between IGRA and TST TB Tests, Women at 44 Weeks Postpartum

IGRA done by Quantiferon Gold Test (QGIT). For women, TST is considered positive if greater than or equal to 5 mm

Women who were tested for tuberculosis infection at 44 weeks postpartum

Posted

Count of Participants

Participants

Measured at Week 44 postpartum

ID	Title	Description
OG000	Positive IGRA TB Test	Women who had positive IGRA TB test at 44 weeks postpartum
OG001	Negative IGRA TB Test	Women who had negative IGRA TB test at 44 weeks postpartum

Units	Counts
Participants	OG000

Secondary

Number of Women by Level of Adherence to Prescribed Regimen, as Assessed by Self-report

Adherence is the percentage of expected doses taken during the 28 week active treatment period, categorized as poor (<60%), reasonable (>= 60%, <80%), good (>=80%, <90%), or excellent (>= 90%). Measured by participant's self-report of doses taken within the last 3 days.

All women enrolled.

Posted

Count of Participants

Participants

Adherence reported every 4 weeks during active treatment; study entry through week 28 for Arm A, week 12 postpartum through week 40 postpartum for Arm B

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit

Secondary

Number of Women by Level of Adherence to Prescribed Regimen, as Assessed by Pill Count

Adherence is the percentage of expected doses taken during the 28 week active treatment period. Pill count: participants returned their prescription pill containers, and the remaining (unused) pills were counted.

All enrolled women

Posted

Count of Participants

Participants

Adherence reported every 4 weeks during active treatment; study entry through week 28 for Arm A, week 12 postpartum through week 40 postpartum for Arm B

ID	Title	Description
OG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
OG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0012 affected479 at risk EG0021 affected445 at risk EG0030 affected464 at risk
Anaemia neonatal	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Anaemia of pregnancy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Haemorrhagic disease of newborn	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Mitral valve prolapse	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Choledochal cyst	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Congenital cytomegalovirus infection	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Congenital hydrocephalus	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Congenital pneumonia	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Congenital syphilis	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Dysmorphism	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Exomphalos	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0021 affected445 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Fever neonatal	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Macrosomia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Sudden infant death syndrome	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0014 affected479 at risk EG0021 affected445 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0013 affected479 at risk EG0020 affected445 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0012 affected479 at risk EG0020 affected445 at risk EG003
Rhesus incompatibility	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Ascariasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Breast abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0023 affected445 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Croup infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Cryptosporidiosis infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Endometritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0013 affected479 at risk EG0023 affected445 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Genitourinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Haemophilus sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Herpangina	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Impetigo	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Meningitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Parvovirus B19 infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0028 affected445 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0022 affected445 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Postpartum sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0012 affected479 at risk EG0020 affected445 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Sepsis neonatal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG00211 affected445 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 affected477 at risk EG0015 affected479 at risk EG0020 affected445 at risk EG003
Vaginal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Viral rash	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Adverse event following immunisation	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Anal injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Foreign body in respiratory tract	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Induced abortion failed	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Uterine rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Symphysiolysis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Convulsion neonatal	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Hypocalcaemic seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0022 affected445 at risk EG003
Intercostal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Paraparesis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
False labour	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG00012 affected477 at risk EG0019 affected479 at risk EG0020 affected445 at risk EG003
Foetal distress syndrome	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0012 affected479 at risk EG0020 affected445 at risk EG003
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Foetal hypokinesia	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0005 affected477 at risk EG0015 affected479 at risk EG0020 affected445 at risk EG003
Haemorrhage in pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0013 affected479 at risk EG0020 affected445 at risk EG003
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Low birth weight baby	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0023 affected445 at risk EG003
Meconium stain	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Peripartum cardiomyopathy	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Placenta praevia	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Postpartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0008 affected477 at risk EG0012 affected479 at risk EG0020 affected445 at risk EG003
Premature baby	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG00210 affected445 at risk EG003
Premature delivery	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0003 affected477 at risk EG0012 affected479 at risk EG0020 affected445 at risk EG003
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0016 affected479 at risk EG0020 affected445 at risk EG003
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Preterm premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Prolonged rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0002 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Small for dates baby	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Stillbirth	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0005 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Threatened labour	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Uterine inversion	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Intentional self-injury	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Major depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Uterine atony	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Meconium aspiration syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0026 affected445 at risk EG003
Neonatal asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0025 affected445 at risk EG003
Neonatal respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Neonatal respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0025 affected445 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Transient tachypnoea of the newborn	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0021 affected445 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Abortion induced	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG0020 affected445 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0010 affected479 at risk EG0020 affected445 at risk EG003

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
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic
D006571	Heterocyclic Compounds
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Arm A (Immediate INH Treatment)	Women in Arm A received immediate, or antepartum-initiated, INH treatment. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum
BG001	Arm B (Deferred INH Treatment)	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from Week 12 postpartum through Week 40 postpartum (Arm B) Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit (Arm B)
BG002	Total	Total of all reporting 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/Immediate INH	Women in Arm A received immediate, or antepartum-initiated, INH treatments. Women received INH at study entry through Week 28, then switched to placebo for INH treatment through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by mouth, from entry through Week 28 antepartum Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from Week 28 visit through Week 40 postpartum.	2	477	71	477	438	477
EG001	Mother/Deferred INH	Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum. Isoniazid (INH): 300-mg tablet once daily by month, from Week 12 postpartum through Week 40 postpartum. Placebo for isoniazid (INH): Placebo tablet once daily by mouth, from entry until Week 12 postpartum visit.	4	479	69	479	449	479
EG002	Infant/Immediate INH	Infants born alive to mothers on arm A (Immediate INH).	11	445	86	445	417	445
EG003	Infant/Deferred INH	Infants born alive to mothers on Arm B (Deferred INH).	17	464	91	464	430	464

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Congenital umbilical hernia	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG00236 affected445 at risk EG00341 affected464 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00024 affected477 at risk EG00115 affected479 at risk EG0022 affected445 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00037 affected477 at risk EG00125 affected479 at risk EG00279 affected445 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00012 affected477 at risk EG00111 affected479 at risk EG00251 affected445 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00017 affected477 at risk EG00114 affected479 at risk EG00229 affected445 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00025 affected477 at risk EG00120 affected479 at risk EG00258 affected445 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 affected477 at risk EG0011 affected479 at risk EG00225 affected445 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 affected477 at risk EG00123 affected479 at risk EG00245 affected445 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00055 affected477 at risk EG00151 affected479 at risk EG0022 affected445 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00052 affected477 at risk EG00147 affected479 at risk EG0020 affected445 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG000187 affected477 at risk EG001206 affected479 at risk EG00231 affected445 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG000141 affected477 at risk EG001151 affected479 at risk EG0029 affected445 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00012 affected477 at risk EG00126 affected479 at risk EG0022 affected445 at risk EG003
Blood glucose decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG000144 affected477 at risk EG001128 affected479 at risk EG0021 affected445 at risk EG003
Blood glucose increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00040 affected477 at risk EG00147 affected479 at risk EG0020 affected445 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG000199 affected477 at risk EG001191 affected479 at risk EG002353 affected445 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00081 affected477 at risk EG00187 affected479 at risk EG002270 affected445 at risk EG003
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00022 affected477 at risk EG00110 affected479 at risk EG00223 affected445 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00096 affected477 at risk EG00197 affected479 at risk EG00215 affected445 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG00223 affected445 at risk EG003
Growth failure	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 affected477 at risk EG0010 affected479 at risk EG00247 affected445 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00094 affected477 at risk EG001109 affected479 at risk EG0020 affected445 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00046 affected477 at risk EG00135 affected479 at risk EG00266 affected445 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00040 affected477 at risk EG00137 affected479 at risk EG0020 affected445 at risk EG003