Trial Outcomes & Findings for Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women (NCT NCT01617096)

Last Updated: 2022-12-21

Results Overview

The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing algorithm. Endpoint confirmation of HIV infection is by Western Blot.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2629 participants

Primary outcome timeframe

minimum of 12 months and a maximum of 14 months per participant

Results posted on

2022-12-21

Participant Flow

Participants provided written informed consent were invited to screen for the clinical trial. Each participant engaged in the screening process for up to 4 weeks (28 days) prior to enrollment. Participants who complied with inclusion and exclusion criteria were invited to enroll in the trial. Participants were randomized in a 1:1 ratio to either the Dapivirine Vaginal Ring or placebo ring group.

Healthy, sexually active HIV-negative women who provided written informed consent were invited to screen for the clinical trial. Each participant engaged in the screening process for up to 4 weeks (28 days) prior to enrollment. Participants who complied with all the inclusion and none of the exclusion criteria were invited to enroll in the clinical trial. Eligible participants were randomly assigned in a 1:1 ratio to either the Dapivirine Vaginal Ring-004 or placebo ring group.

Participant milestones

Participant milestones
Measure	Dapivirine Vaginal Ring Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Overall Study STARTED	1313	1316
Overall Study COMPLETED	1165	1179
Overall Study NOT COMPLETED	148	137

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapivirine Vaginal Ring Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Overall Study Withdrawal by Subject	96	81
Overall Study Lost to Follow-up	37	32
Overall Study Physician Decision	10	18
Overall Study Death	4	3
Overall Study Other	1	3

Baseline Characteristics

Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapivirine Vaginal Ring n=1313 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1316 Participants Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance	Total n=2629 Participants Total of all reporting groups
Age, Continuous	27.2 years STANDARD_DEVIATION 6.09 • n=5 Participants	27.3 years STANDARD_DEVIATION 6.28 • n=7 Participants	27.2 years STANDARD_DEVIATION 6.18 • n=5 Participants
Sex: Female, Male Female	1313 Participants n=5 Participants	1316 Participants n=7 Participants	2629 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1228 Participants n=5 Participants	1226 Participants n=7 Participants	2454 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	70 Participants n=5 Participants	87 Participants n=7 Participants	157 Participants n=5 Participants
Region of Enrollment South Africa	713 Participants n=5 Participants	713 Participants n=7 Participants	1426 Participants n=5 Participants
Region of Enrollment Zimbabwe	338 Participants n=5 Participants	340 Participants n=7 Participants	678 Participants n=5 Participants
Region of Enrollment Malawi	135 Participants n=5 Participants	137 Participants n=7 Participants	272 Participants n=5 Participants
Region of Enrollment Uganda	127 Participants n=5 Participants	126 Participants n=7 Participants	253 Participants n=5 Participants
BMI	26.8 kg/(m^2) STANDARD_DEVIATION 6.41 • n=5 Participants	27.2 kg/(m^2) STANDARD_DEVIATION 6.93 • n=7 Participants	27.0 kg/(m^2) STANDARD_DEVIATION 6.68 • n=5 Participants
Education Status Less than Secondary School	212 Participants n=5 Participants	192 Participants n=7 Participants	404 Participants n=5 Participants
Education Status Secondary School and Higher	1101 Participants n=5 Participants	1124 Participants n=7 Participants	2225 Participants n=5 Participants
Marital Status Married	527 Participants n=5 Participants	547 Participants n=7 Participants	1074 Participants n=5 Participants
Marital Status Non-Married	786 Participants n=5 Participants	767 Participants n=7 Participants	1553 Participants n=5 Participants
Marital Status Missing	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Has children	1188 Participants n=5 Participants	1177 Participants n=7 Participants	2365 Participants n=5 Participants
Has main partner Yes	1307 Participants n=5 Participants	1309 Participants n=7 Participants	2616 Participants n=5 Participants
Has main partner Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Has main partner No	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Presence of STIs	268 Participants n=5 Participants	265 Participants n=7 Participants	533 Participants n=5 Participants
Partner knowledge of ring use Yes	835 Participants n=5 Participants	845 Participants n=7 Participants	1680 Participants n=5 Participants
Partner knowledge of ring use Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Partner knowledge of ring use No	478 Participants n=5 Participants	470 Participants n=7 Participants	948 Participants n=5 Participants
Number of sex partners in the last 3 months 0-1 partners	1101 Participants n=5 Participants	1089 Participants n=7 Participants	2190 Participants n=5 Participants
Number of sex partners in the last 3 months >2	212 Participants n=5 Participants	227 Participants n=7 Participants	439 Participants n=5 Participants

PRIMARY outcome

Timeframe: minimum of 12 months and a maximum of 14 months per participant

Population: The primary effectiveness Cohort included all eligible randomised participants excluding participants deemed to be HIV-1 RNA positive at the time of randomization, based on retrospective PCR testing of stored blood samples taken at enrollment.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=1313 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1313 Participants Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Efficacy as Determined by the Proportion of Women in Each Arm With HIV-1 Seroconversion After 120 Endpoints Are Observed in the Trial.	71 Participants	97 Participants

PRIMARY outcome

Timeframe: minimum of 12 months and a maximum of 14 months per participant

Population: The Primary Safety Cohort (or ITT Cohort) included all eligible, randomized participants. All participants were analyzed as members of the treatment group to which they were randomized regardless of adherence to the planned course of treatment.

Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events. DAIDS severity grades are defined as follows: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=1313 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1316 Participants Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).	1237 Participants	1231 Participants

SECONDARY outcome

Timeframe: 12 months per participant

Population: Adherence is defined by a dapivirine residual level in returned used rings ≤ 23.5 mg and a dapivirine plasma concentration ≥ 95 pg/mL (if they are both available; otherwise categorisation was based on the available measurement. The objective measures (dapivirine residual levels in used rings and dapivirine plasma concentrations) used can only be determined for participants who used the active vaginal dapivirine ring.

Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use. Adherence was defined as a dapivirine ring residual level \<=23.5 mg and dapivirine plasma level \>= 95 pg/mL.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=1288 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Adherence to the Dapivirine Vaginal Ring. Month 1	443 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 2	460 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 3	953 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 4	537 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 5	573 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 6	963 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 7	687 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 8	699 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 9	943 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 10	830 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 11	916 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 12	922 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 13	872 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 14	858 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 15	793 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 16	704 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 17	701 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 18	675 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 19	600 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 20	598 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 21	576 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 22	499 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 23	485 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 24	471 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 25	391 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 26	384 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 27	367 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 28	263 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 29	258 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 30	251 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 31	133 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 32	130 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 33	120 participants with data	—
Adherence to the Dapivirine Vaginal Ring. Month 34	4 participants with data	—

SECONDARY outcome

Timeframe: 12 months per participant

Population: The Primary Safety Cohort (or ITT Cohort) included all eligible, randomized participants. Acceptability was reported for participant who provided responses to acceptability questionnaires.

Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Percentage of participants with positive response. Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?'

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=1072 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1062 Participants Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Acceptability of the DVR and Placebo Vaginal Ring	95.9 percentage of participants with data	96.8 percentage of participants with data

SECONDARY outcome

Timeframe: minimum of 12 months and a maximum of 14 months per participant

Population: The virology population included all ITT participants with seroconversion, excluding those who never received investigational product, or were retrospectively found to be HIV-1 RNA positive at enrollment (m-ITT) or were HIV-1 infected after discontinuation of ring use. Seroconversions among participants who were continued on open-label DVR-004 were included in the DVR-004 group, independent of initial randomization.

The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters. The percentage of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.

Outcome measures

Outcome measures
Measure	Dapivirine Vaginal Ring n=71 Participants Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=97 Participants Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Human Immunodeficiency Virus Type 1 Drug Resistance Mutations Among Participants Who Acquired HIV-1 Infection.	68 Participants	96 Participants

Adverse Events

Dapivirine Vaginal Ring

Serious events: 116 serious events

Other events: 1237 other events

Deaths: 4 deaths

Placebo Ring

Serious events: 130 serious events

Other events: 1041 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Dr John Steytler

International Partnership for Microbicides

Phone: +27218602300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Dapivirine Vaginal Ring n=1313 participants at risk Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1316 participants at risk Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Reproductive system and breast disorders Vaginal Discharge	1.3% 17/1313 • Number of events 17 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	1.5% 20/1316 • Number of events 21 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Pelvic Pain	1.1% 15/1313 • Number of events 17 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	1.5% 20/1316 • Number of events 22 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Metrorrhagia	1.2% 16/1313 • Number of events 17 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.68% 9/1316 • Number of events 9 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal Pruritus	0.76% 10/1313 • Number of events 11 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.91% 12/1316 • Number of events 13 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal discomfort	0.69% 9/1313 • Number of events 9 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.38% 5/1316 • Number of events 7 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervix erythema	0.46% 6/1313 • Number of events 6 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.38% 5/1316 • Number of events 5 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vaginal odour	0.23% 3/1313 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.61% 8/1316 • Number of events 8 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Dyspareunia	0.30% 4/1313 • Number of events 4 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.15% 2/1316 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Menorrhagia	0.23% 3/1313 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.23% 3/1316 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Pelvic discomfort	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.23% 3/1316 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervical dysplasia	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.15% 2/1316 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Uterine Pain	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.23% 3/1316 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervical discharge	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.15% 2/1316 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervix haemorrage uterine	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervix oedema	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.00% 0/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Coital bleeding	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Menometrorrhagia	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vaginal erosion	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.00% 0/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal dryness	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal pain	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Genital discomfort	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.00% 0/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Pruritius genital	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Uterine Cervical pain	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Uterine Cervix ulcer	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Aspartate aminotransferase increased	0.30% 4/1313 • Number of events 4 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.68% 9/1316 • Number of events 9 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Alanine aminotransferase increased	0.23% 3/1313 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.53% 7/1316 • Number of events 7 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Neutrophil count decreased	0.30% 4/1313 • Number of events 4 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.46% 6/1316 • Number of events 6 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Haemoglobin decreased	0.23% 3/1313 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations White blood cell count decreased	0.08% 1/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Lymphocyte count decreased	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Platelet count decreased	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.00% 0/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Cervicitis	0.15% 2/1313 • Number of events 3 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.46% 6/1316 • Number of events 7 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vulvovaginitis	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.38% 5/1316 • Number of events 5 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Urinary tract infection	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.38% 5/1316 • Number of events 5 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vulvovaginal candidiasis	0.15% 2/1313 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.00% 0/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Pelvic inflammatory disease	0.00% 0/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.08% 1/1316 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
General disorders Application site discomfort	0.30% 4/1313 • Number of events 4 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.15% 2/1316 • Number of events 2 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
General disorders Application site pain	0.08% 1/1313 • Number of events 1 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	0.30% 4/1316 • Number of events 4 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.

Other adverse events
Measure	Dapivirine Vaginal Ring n=1313 participants at risk Vaginal ring containing 25mg dapivirine Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months	Placebo Ring n=1316 participants at risk Vaginal ring containing no drug substance Placebo Ring: Vaginal ring containing no drug substance
Reproductive system and breast disorders Metrorrhagia	55.1% 723/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	55.6% 732/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Menorrhagia	19.7% 259/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	18.4% 242/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vaginal discharge	13.6% 179/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	13.2% 174/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Menometrorrhagia	12.2% 160/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	11.2% 148/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulvovaginal pruritus	9.7% 128/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	10.3% 135/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Cervical dysplasia	9.7% 127/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	9.3% 123/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Pelvic pain	3.2% 42/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	3.5% 46/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Vulval ulceration	2.2% 29/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.7% 35/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Reproductive system and breast disorders Amenorrhoea	2.3% 30/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.3% 30/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Genitourinary chlamydia infection	20.5% 269/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	20.8% 274/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Urinary tract infection	17.0% 223/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	21.4% 281/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Bacterial vaginosis	12.8% 168/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	11.9% 157/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vulvovaginitis trichomonal	11.3% 149/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	12.0% 158/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Genitourinary tract gonococcal infection	10.9% 143/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	12.2% 160/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Upper respiratory tract infection	10.7% 140/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	10.6% 139/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vulvovaginal candidiasis	11.3% 148/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	9.7% 127/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Malaria	5.5% 72/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	5.8% 76/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Gastroenteritis	4.6% 61/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	4.5% 59/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Tonsillitis	4.1% 54/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	4.3% 57/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vaginal Infection	3.9% 51/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	4.5% 59/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Vulvovaginitis	4.0% 53/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	3.8% 50/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Respiratory tract infection	2.8% 37/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	1.9% 25/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Folliculitis	2.2% 29/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.0% 26/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Infections and infestations Pelvic inflammatory disease	2.1% 27/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.1% 28/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Alanine aminotransferase increased	11.2% 147/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	12.2% 160/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Aspartate aminotransferase increased	11.0% 144/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	11.0% 145/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Haemoglobin decreased	9.5% 125/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	10.9% 143/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Neutrophil count decreased	9.0% 118/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	11.1% 146/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Investigations Blood creatinine increased	2.0% 26/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.3% 30/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Metabolism and nutrition disorders Abnormal loss of weight	13.2% 173/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	13.3% 175/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Metabolism and nutrition disorders Decreased appetite	1.9% 25/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.0% 26/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Injury, poisoning and procedural complications Procedural pain	6.0% 79/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	7.2% 95/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Gastrointestinal disorders Diarrhoea	2.3% 30/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	3.0% 39/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Blood and lymphatic system disorders Neutropenia	3.0% 40/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.3% 30/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Blood and lymphatic system disorders Anaemia	3.1% 41/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	1.9% 25/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Nervous system disorders Headache	3.1% 41/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	3.4% 45/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.
Renal and urinary disorders Dysuria	2.6% 34/1313 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.	2.7% 36/1316 • 24 Months The analysis of AEs was mainly descriptive in nature. The number and percentage of participants who experienced AEs are presented by Medical Dictionary for Regulatory Activities System Organ Class and preferred term, and by treatment group. Separate tabulations were created for AEs of special interest, ie, urogenital AEs and STIs. For this purpose, preferred terms were grouped into categories of interest. Urogenital and gynecological AEs were also analyzed separately.