Trial Outcomes & Findings for Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs (NCT NCT04140266)

Last Updated: 2023-08-04

Results Overview

This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

394 participants

Primary outcome timeframe

Measured through Month 3.5

Results posted on

2023-08-04

Participant Flow

197 mother-infant pairs were enrolled in 4 African countries from September 2020 until July 2021.

197 mother-infant pairs were enrolled in the study. When the mothers are enrolled and discontinued from the study, their infants are enrolled or discontinued.

Participant milestones

Participant milestones
Measure	Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months. Dapivirine (DPV) Vaginal Ring (VR)-004: Vaginal ring containing 25 mg of DPV	Group B: Truvada Tablet Mothers will take one Truvada oral tablet daily for approximately three months. Truvada Tablet: Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)
Overall Study STARTED	296	98
Overall Study Mothers	148	49
Overall Study Infants	148	49
Overall Study COMPLETED	290	96
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months. Dapivirine (DPV) Vaginal Ring (VR)-004: Vaginal ring containing 25 mg of DPV	Group B: Truvada Tablet Mothers will take one Truvada oral tablet daily for approximately three months. Truvada Tablet: Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	4	2

Baseline Characteristics

Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.	Infants - Group A: DPV VR n=148 Participants Adverse Events for Infants of Mothers randomized to the DPV VR study arm.	Infants - Group B: Truvada Tablet n=49 Participants Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.	Total n=394 Participants Total of all reporting groups
Age, Continuous Mothers' Age, years	26 years n=148 Participants • Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks.	25 years n=49 Participants • Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks.	—	—	26 years n=197 Participants • Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks.
Age, Continuous Infants' Age, weeks	—	—	9 weeks n=148 Participants • Only infants are included in this baseline measure since infant age is summarized in weeks.	8 weeks n=49 Participants • Only infants are included in this baseline measure since infant age is summarized in weeks.	9 weeks n=197 Participants • Only infants are included in this baseline measure since infant age is summarized in weeks.
Age, Customized mother age · 18-19 years	14 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	5 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	19 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized mother age · 20-24 years	50 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	17 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	67 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized mother age · 25-29 years	42 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	12 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	54 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized mother age · 30-34 years	28 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	12 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	40 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized mother age · 35-39 years	13 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	3 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	16 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized mother age · 40-45 years	1 Participants n=148 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants n=49 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	0 Participants Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.	1 Participants n=197 Participants • Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.
Age, Customized Infant age · 6 to 9 weeks	0 Participants Only infants are included in this baseline measure since infant age is categorized in weeks.	0 Participants Only infants are included in this baseline measure since infant age is categorized in weeks.	87 Participants n=148 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.	34 Participants n=49 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.	121 Participants n=197 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.
Age, Customized Infant age · >9 weeks to 12 weeks	0 Participants Only infants are included in this baseline measure since infant age is categorized in weeks.	0 Participants Only infants are included in this baseline measure since infant age is categorized in weeks.	61 Participants n=148 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.	15 Participants n=49 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.	76 Participants n=197 Participants • Only infants are included in this baseline measure since infant age is categorized in weeks.
Sex: Female, Male Female	148 Participants n=148 Participants	49 Participants n=49 Participants	84 Participants n=148 Participants	24 Participants n=49 Participants	305 Participants n=394 Participants
Sex: Female, Male Male	0 Participants n=148 Participants	0 Participants n=49 Participants	64 Participants n=148 Participants	25 Participants n=49 Participants	89 Participants n=394 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	148 Participants n=148 Participants	49 Participants n=49 Participants	148 Participants n=148 Participants	49 Participants n=49 Participants	394 Participants n=394 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) Asian	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) Black or African American	148 Participants n=148 Participants	49 Participants n=49 Participants	148 Participants n=148 Participants	49 Participants n=49 Participants	394 Participants n=394 Participants
Race (NIH/OMB) White	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) More than one race	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=148 Participants	0 Participants n=49 Participants	0 Participants n=394 Participants
Region of Enrollment Malawi	29 participants n=148 Participants	10 participants n=49 Participants	29 participants n=148 Participants	10 participants n=49 Participants	78 participants n=394 Participants
Region of Enrollment South Africa	27 participants n=148 Participants	9 participants n=49 Participants	27 participants n=148 Participants	9 participants n=49 Participants	72 participants n=394 Participants
Region of Enrollment Uganda	42 participants n=148 Participants	13 participants n=49 Participants	42 participants n=148 Participants	13 participants n=49 Participants	110 participants n=394 Participants
Region of Enrollment Zimbabwe	50 participants n=148 Participants	17 participants n=49 Participants	50 participants n=148 Participants	17 participants n=49 Participants	134 participants n=394 Participants

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: All Mothers received study product and are used in the analysis population.

As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010)

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: All enrolled mothers received study product.

As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies \[Dated November 2007\])

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms	3 Participants	2 Participants

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: All infants were exposed to study product through mothers' breastmilk. All enrolled mothers received study product.

As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010)

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: Infants were exposed to study product through breastmilk. All enrolled mothers received study product.

As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms	10 Participants	1 Participants

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=147 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Week 1	139 Participants	—
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Week 2	136 Participants	—
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Month 1	139 Participants	—
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Month 2	138 Participants	—
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Product Use End Visit	136 Participants	—
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations Study End Visit	48 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Week 1	45 Participants	—
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Week 2	46 Participants	—
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Month 1	38 Participants	—
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Month 2	34 Participants	—
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Product Use End Visit	38 Participants	—
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations Study End Visit	1 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Month 2	44 Participants	—
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Product Use End Visit	47 Participants	—
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Study End Visit	45 Participants	—
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Week 1	47 Participants	—
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Week 2	48 Participants	—
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations Month 1	45 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population.

This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=146 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Week 1	137 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Week 2	137 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Month 1	138 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Month 2	138 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Product Use End Visit	135 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations Study End Visit	94 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population.

This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Week 1	47 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Week 2	45 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Month 1	44 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Month 2	39 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Product Use End Visit	40 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations Study End Visit	1 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Week 1	47 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Week 2	44 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Month 1	42 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Month 2	38 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Product Use End Visit	38 Participants	—
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations Study End Visit	3 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the infants of mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=147 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Infants With Detectable Plasma DPV Concentrations Week 2	21 Participants	—
Number and Proportion of Infants With Detectable Plasma DPV Concentrations Month 1	20 Participants	—
Number and Proportion of Infants With Detectable Plasma DPV Concentrations Month 2	14 Participants	—
Number and Proportion of Infants With Detectable Plasma DPV Concentrations Product Use End Visit	7 Participants	—
Number and Proportion of Infants With Detectable Plasma DPV Concentrations Study Exit Visit	0 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

Population: This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Infants With Detectable FTC-TP Concentrations Week 2	4 Participants	—
Number and Proportion of Infants With Detectable FTC-TP Concentrations Month 1	2 Participants	—
Number and Proportion of Infants With Detectable FTC-TP Concentrations Month 2	2 Participants	—
Number and Proportion of Infants With Detectable FTC-TP Concentrations Product Use End Visit	1 Participants	—
Number and Proportion of Infants With Detectable FTC-TP Concentrations Study Exit Visit	0 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Number and Proportion of Infants With Detectable TFV-DP Concentrations Week 2	0 Participants	—
Number and Proportion of Infants With Detectable TFV-DP Concentrations Month 1	0 Participants	—
Number and Proportion of Infants With Detectable TFV-DP Concentrations Month 2	0 Participants	—
Number and Proportion of Infants With Detectable TFV-DP Concentrations Product Use End Visit	0 Participants	—
Number and Proportion of Infants With Detectable TFV-DP Concentrations Study Exit Visit	0 Participants	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=147 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Month 2	263.8 pg/mL Geometric Coefficient of Variation 111.9	—
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Week 1	327.9 pg/mL Geometric Coefficient of Variation 61.3	—
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Week 2	314.9 pg/mL Geometric Coefficient of Variation 92.1	—
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Month 1	275.4 pg/mL Geometric Coefficient of Variation 76.9	—
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Product Use End Visit	260.4 pg/mL Geometric Coefficient of Variation 87.3	—
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit Study End Visit	16.7 pg/mL Geometric Coefficient of Variation 93.5	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal FTC-TP Concentrations by Visit Week 1	0.3 pmol/punch Geometric Coefficient of Variation 51.3	—
Geometric Mean of Maternal FTC-TP Concentrations by Visit Week 2	0.3 pmol/punch Geometric Coefficient of Variation 58.4	—
Geometric Mean of Maternal FTC-TP Concentrations by Visit Month 1	0.3 pmol/punch Geometric Coefficient of Variation 91.5	—
Geometric Mean of Maternal FTC-TP Concentrations by Visit Month 2	0.2 pmol/punch Geometric Coefficient of Variation 90.9	—
Geometric Mean of Maternal FTC-TP Concentrations by Visit Product Use End Visit	0.2 pmol/punch Geometric Coefficient of Variation 91.3	—
Geometric Mean of Maternal FTC-TP Concentrations by Visit Study End Visit	0.1 pmol/punch Geometric Coefficient of Variation 21.9	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal TFV-DP Concentrations by Visit Week 1	254.6 fmol/punch Geometric Coefficient of Variation 62.8	—
Geometric Mean of Maternal TFV-DP Concentrations by Visit Week 2	424.2 fmol/punch Geometric Coefficient of Variation 65.2	—
Geometric Mean of Maternal TFV-DP Concentrations by Visit Month 1	524.7 fmol/punch Geometric Coefficient of Variation 117.8	—
Geometric Mean of Maternal TFV-DP Concentrations by Visit Month 2	551.9 fmol/punch Geometric Coefficient of Variation 97.5	—
Geometric Mean of Maternal TFV-DP Concentrations by Visit Product Use End Visit	591.5 fmol/punch Geometric Coefficient of Variation 135.5	—
Geometric Mean of Maternal TFV-DP Concentrations by Visit Study End Visit	330.8 fmol/punch Geometric Coefficient of Variation 137.8	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=146 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Week 1	529.4 pg/mL Geometric Coefficient of Variation 108.0	—
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Week 2	492.0 pg/mL Geometric Coefficient of Variation 122.3	—
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Month 1	457.0 pg/mL Geometric Coefficient of Variation 119.3	—
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Month 2	418.9 pg/mL Geometric Coefficient of Variation 545.0	—
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Product Use End Visit	402.8 pg/mL Geometric Coefficient of Variation 154.5	—
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit Study End Visit	20.0 pg/mL Geometric Coefficient of Variation 210.7	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Week 1	552.6 mg/mL Geometric Coefficient of Variation 167.4	—
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Week 2	447.6 mg/mL Geometric Coefficient of Variation 329.0	—
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Month 1	319.9 mg/mL Geometric Coefficient of Variation 453.8	—
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Month 2	313.0 mg/mL Geometric Coefficient of Variation 707.9	—
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Product Use End Visit	296.6 mg/mL Geometric Coefficient of Variation 1099.2	—
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit Study End Visit	2.8 mg/mL Geometric Coefficient of Variation 88.9	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Week 1	5.6 ng/mL Geometric Coefficient of Variation 72.3	—
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Week 2	4.3 ng/mL Geometric Coefficient of Variation 89.5	—
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Month 1	3.3 ng/mL Geometric Coefficient of Variation 108.3	—
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Month 2	3.2 ng/mL Geometric Coefficient of Variation 120.0	—
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Product Use End Visit	2.7 ng/mL Geometric Coefficient of Variation 107.2	—
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit Study End Visit	0.6 ng/mL Geometric Coefficient of Variation 106.5	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=147 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Infant DPV Concentrations From Plasma by Visit Week 2	11.7 pg/mL Geometric Coefficient of Variation 46.3	—
Geometric Mean of Infant DPV Concentrations From Plasma by Visit Month 1	11.5 pg/mL Geometric Coefficient of Variation 35.7	—
Geometric Mean of Infant DPV Concentrations From Plasma by Visit Month 2	11.0 pg/mL Geometric Coefficient of Variation 31.7	—
Geometric Mean of Infant DPV Concentrations From Plasma by Visit Product Use End Visit	10.5 pg/mL Geometric Coefficient of Variation 19.8	—
Geometric Mean of Infant DPV Concentrations From Plasma by Visit Study End Visit	10 pg/mL Geometric Coefficient of Variation 0	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Infant FTC-TP Concentration by Visit Week 2	0.1 pmol/punch Geometric Coefficient of Variation 23.5	—
Geometric Mean of Infant FTC-TP Concentration by Visit Month 1	0.1 pmol/punch Geometric Coefficient of Variation 16.3	—
Geometric Mean of Infant FTC-TP Concentration by Visit Month 2	0.1 pmol/punch Geometric Coefficient of Variation 15.4	—
Geometric Mean of Infant FTC-TP Concentration by Visit Product Use End Visit	0.1 pmol/punch Geometric Coefficient of Variation 12.1	—
Geometric Mean of Infant FTC-TP Concentration by Visit Study End Visit	0.1 pmol/punch Geometric Coefficient of Variation 0	—

PRIMARY outcome

Timeframe: Measured through Month 3.5

This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=48 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Geometric Mean of Infant TFV-DP Concentrations by Visit Product Use End Visit	15.6 fmol/punch Geometric Coefficient of Variation 0	—
Geometric Mean of Infant TFV-DP Concentrations by Visit Week 2	15.6 fmol/punch Geometric Coefficient of Variation 0	—
Geometric Mean of Infant TFV-DP Concentrations by Visit Month 1	15.6 fmol/punch Geometric Coefficient of Variation 0	—
Geometric Mean of Infant TFV-DP Concentrations by Visit Month 2	15.6 fmol/punch Geometric Coefficient of Variation 0	—
Geometric Mean of Infant TFV-DP Concentrations by Visit Study End Visit	15.6 fmol/punch Geometric Coefficient of Variation 0	—

SECONDARY outcome

Timeframe: Measured through Month 3

Population: Only mother participants are included in this endpoint since infants did not directly use study product. The number of mothers analyzed includes mother participants with a returned/used vaginal ring that was successfully analyzed for residual drug concentration (evaluable) for Group A (DPV VR) and only those participants with an available and evaluable dried blood plot specimen for mothers in Group B (Truvada). Rings returned after the Month 3 Product Use End Visit (PUEV) are excluded.

The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs \<= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations \< 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=144 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=46 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product Month 1	14 Participants	2 Participants
The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product Month 2	28 Participants	0 Participants
The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product Month 3	29 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured through Month 3.5

Population: The analysis population includes mothers with evaluable residual DPV concentrations from returned vaginal rings (VRs). Rings returned on or after the Month 3 visit are included in the Month 3 summary.

The residual DPV concentrations from the returned VRs are summarized.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=144 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Residual Drug Levels in Returned VRs Month 1	22.1 mg Interval 21.4 to 22.8	—
Residual Drug Levels in Returned VRs Month 2	22.4 mg Interval 21.5 to 23.3	—
Residual Drug Levels in Returned VRs Month 3	22.1 mg Interval 21.3 to 23.6	—

SECONDARY outcome

Timeframe: Measured through Month 3.5

Population: The number of mothers analyzed includes all mothers who completed the Product End Use Visit Behavioral Assessment and responded to the willingness question. The count of participants who are willing, responded "Yes" to the question.

Based on participant report to the question "Would you be willing to use the study product for HIV prevention while breastfeeding in the future?"

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=145 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=48 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)	142 Participants	48 Participants

SECONDARY outcome

Timeframe: Measured through Month 3.5

Population: The number of mothers analyzed included those who completed the Product End Use Visit Behavioral Assessment and responded to the acceptability question. The mothers who answered "Like very much" or "Like" are included in the total who find the study product acceptable.

Based on participant report on the question "Overall, how much did you like using the study product?" on the Product End Use Visit Behavioral Assessment.

Outcome measures

Outcome measures
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=145 Participants Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=47 Participants Adverse Events for Mothers randomized to the Truvada oral tablet study arm.
Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods	141 Participants	46 Participants

Adverse Events

Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004

Serious events: 2 serious events

Other events: 92 other events

Deaths: 0 deaths

Mothers - Group B: Truvada Tablet

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Infants - Group A: DPV VR

Serious events: 4 serious events

Other events: 112 other events

Deaths: 0 deaths

Infants - Group B: Truvada Tablet

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 n=148 participants at risk Adverse Events for Mothers randomized to the DPV VR study arm.	Mothers - Group B: Truvada Tablet n=49 participants at risk Adverse Events for Mothers randomized to the Truvada oral tablet study arm.	Infants - Group A: DPV VR n=148 participants at risk Adverse Events for Infants of Mothers randomized to the DPV VR study arm.	Infants - Group B: Truvada Tablet n=49 participants at risk Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.
Infections and infestations Any Event in SOC	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	2.7% 4/148 • Number of events 4 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Infections and infestations Appendiceal abscess	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Infections and infestations Bronchiolitis	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	1.4% 2/148 • Number of events 2 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Infections and infestations Dysentery	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Infections and infestations Pneumonia	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Any Event in SOC	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.68% 1/148 • Number of events 1 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/148 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.	0.00% 0/49 • The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days). The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.

Other adverse events

Additional Information

Jen Balkus

Hans Rosling Center for Population Health

Phone: 260 616 6614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place