Trial Outcomes & Findings for Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV (NCT NCT05413811)
NCT ID: NCT05413811
Last Updated: 2026-08-21
Results Overview
Retention was defined as the number of participants who remained in follow-up and completed the Week 24 study visit. The number and percentage of participants retained at Week 24 were reported for each study arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Baseline (Week 0) through Week 24
Results posted on
2026-08-21
Participant Flow
Participant milestones
| Measure |
5 Fluorouracil (5FU) Cream
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
Randomized (Week 4)
|
90
|
90
|
|
Overall Study
Received ≥1 Dose of Study Treatment
|
90
|
90
|
|
Overall Study
Week 10 Visit Completed
|
86
|
90
|
|
Overall Study
Week 18 Visit Completed
|
81
|
89
|
|
Overall Study
Week 24 Visit Completed
|
83
|
89
|
|
Overall Study
COMPLETED
|
83
|
89
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
5 Fluorouracil (5FU) Cream
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Participant Relocation
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
Baseline characteristics by cohort
| Measure |
5 Fluorouracil (5FU) Cream
n=90 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
n=5 Participants
|
42 years
n=109 Participants
|
42 years
n=133 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
90 Participants
n=109 Participants
|
180 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=5 Participants
|
90 Participants
n=109 Participants
|
180 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Region of Enrollment
South Africa
|
90 Participants
n=5 Participants
|
90 Participants
n=109 Participants
|
180 Participants
n=133 Participants
|
|
Years Since HIV Diagnosis
|
10 years
n=5 Participants
|
7.5 years
n=109 Participants
|
9 years
n=133 Participants
|
|
HPV Vaccination
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
High-Risk HPV Positive
|
77 Participants
n=5 Participants
|
81 Participants
n=109 Participants
|
158 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) through Week 24Population: The primary analysis population included all randomized participants (n=90 per arm), consistent with an intention-to-treat (ITT) approach. Participants were analyzed in the groups to which they were randomized.
Retention was defined as the number of participants who remained in follow-up and completed the Week 24 study visit. The number and percentage of participants retained at Week 24 were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=90 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants Retained in the Study Through Week 24
|
89 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: The analysis population was restricted to participants who completed the Week 10 visit and had an acceptability assessment available. At Week 10, 90 participants in the placebo arm and 86 participants in the 5FU arm met these criteria and were included in the analysis.
Acceptability was defined as a summary score ≥80% on a 7-item questionnaire administered at Week 10. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=86 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants With ≥80% Acceptability Summary Score at Week 10
|
86 Participants
|
82 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The analysis population was restricted to participants who completed the Week 24 visit or a Week 18 visit and had an acceptability assessment available. By Week 24, 89 participants in the placebo arm and 83 participants in the 5FU arm were included in the analysis. One participant in the placebo arm completed their acceptability questionnaire at Week 18 and are included in the analysis.
Acceptability was defined as a summary score ≥80% on the same 7-item questionnaire administered at Week 24. Each item was rated on a 5-point Likert scale and coded from 0 (lowest acceptability) to 4 (highest acceptability), yielding a total possible score of 0 to 28. A summary acceptability score was calculated as a percentage (0% to 100%) of the total possible score. The number and percentage of participants meeting this definition were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=83 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants With ≥80% Acceptability Summary Score by Week 24
|
85 Participants
|
78 Participants
|
PRIMARY outcome
Timeframe: Week 4 (randomization) through Week 24Population: All randomized participants that received at least one dose of study treatment were included in the denominator (modified-ITT).
A safety event was defined as any Grade 2 or higher adverse event (AE), or any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to the study drug. Adverse events were assessed from Week 4 (randomization) through Week 24. The number and percentage of participants experiencing at least one such event were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=90 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants Experiencing a Treatment-Related Grade ≥2 Adverse Event or Grade 1 Genital Lesion
|
24 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Week 4 (randomization) through Week 18Population: All randomized participants that received at least one dose of study treatment were included in the denominator (modified-ITT).
A tolerability event was defined as inability or unwillingness to apply ≥4 of 8 planned doses of the study treatment due to a dose-limiting toxicity (DLT). A DLT was defined as (1) any Grade 2 or higher AE, or (2) any Grade 1 AE involving a genital lesion (blister, ulceration, or pustule), that was assessed as possibly, probably, or definitely related to study drug and resulted in an investigator decision to reduce the number of doses or discontinue study treatment. Tolerability was assessed from randomization through the dosing period (Week 18), with follow-up censored at the last tolerability assessment for participants who exited early without experiencing an event. The number and percentage of participants experiencing a tolerability event were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=90 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants Unable or Unwilling to Apply ≥50% of Study Cream Doses Due to Dose-Limiting Toxicity
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 4 (randomization) through Week 24Population: All randomized participants that received at least one dose of study treatment were included in the denominator (modified-ITT). Participants with missing or incomplete applicator readings were considered non-adherent.
Adherence was defined as administration of at ≥6 of 8 planned doses of study treatment, as determined by ultraviolet inspection of returned applicators. Applicator collection occurred through Week 24, including for participants who completed dosing earlier, to allow complete ascertainment of dose use. Each applicator was independently assessed by ≥2 reviewers; in cases of disagreement, a third reviewer adjudicated the result. Participants were classified as adherent if ≥6 applicators showed evidence of use. Participants who did not meet this threshold, including those with missing or incomplete applicator data, were classified as non-adherent. The number and percentage of participants meeting this definition were reported for each study arm.
Outcome measures
| Measure |
Placebo Cream
n=90 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=90 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Number of Participants Adherent to ≥75% of Study Cream Doses Based on Ultraviolet Inspection
|
86 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) through Week 24Population: All randomized participants that had Week 24 cervical biopsy results were included in this analysis.
The analysis population included all randomized participants, all of whom had CIN2 or CIN3 at baseline (Week 0) confirmed by loop electrosurgical excision procedure (LEEP) histology. The analysis population was restricted to participants who completed the Week 24 visit and had cervical biopsy results available. This included 89 participants in the placebo arm and 81 participants in the 5FU arm. Regression was defined as improvement from CIN2 or CIN3 at baseline to CIN1 or normal histology at Week 24, as assessed by cervical biopsy. Participants missing Week 24 data were not included and not considered to have experienced CIN2/3 regression. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages.
Outcome measures
| Measure |
Placebo Cream
n=89 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=81 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Percent of Participants With CIN2/3 at Baseline Who Regressed to CIN1 or Normal Histology at Week 24
|
82.0 percentage of participants
Interval 72.8 to 88.6
|
96.3 percentage of participants
Interval 89.7 to 98.7
|
SECONDARY outcome
Timeframe: Baseline (Week 0) through Week 24Population: All randomized participants that were positive for hrHPV at baseline (Week 0) and had Week 24 hrHPV results were included in this analysis.
The analysis population was restricted to participants with at least one high-risk HPV (hrHPV) genotype detected at baseline and with hrHPV results available at Week 24. A total of 69 participants in the 5FU arm and 80 participants in the placebo arm met these criteria. High-risk HPV clearance was defined as absence at Week 24 of all hrHPV genotypes detected at baseline. Participants without baseline hrHPV infection or without Week 24 hrHPV results were excluded from this analysis. The number and percentage of participants meeting this definition were reported for each study arm. The Wilson score method was used to estimate 95% confidence intervals around percentages.
Outcome measures
| Measure |
Placebo Cream
n=80 Participants
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream
n=69 Participants
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
|---|---|---|
|
Percent of Participants With Baseline High-Risk HPV Who Achieved Genotype-Specific Clearance at Week 24
|
53.8 percentage of participants
Interval 42.9 to 64.3
|
58.0 percentage of participants
Interval 46.2 to 68.9
|
Adverse Events
5 Fluorouracil (5FU) Cream
Serious events: 2 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo Cream
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
5 Fluorouracil (5FU) Cream: Prior to Treatment (Weeks 0-4)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Cream: Prior to Treatment (Weeks 0-4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 Fluorouracil (5FU) Cream
n=90 participants at risk
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream
n=90 participants at risk
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream: Prior to Treatment (Weeks 0-4)
n=90 participants at risk
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream: Prior to Treatment (Weeks 0-4)
n=90 participants at risk
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Immune system disorders
Autoimmune disorder
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
Other adverse events
| Measure |
5 Fluorouracil (5FU) Cream
n=90 participants at risk
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream
n=90 participants at risk
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
5 Fluorouracil (5FU) Cream: Prior to Treatment (Weeks 0-4)
n=90 participants at risk
Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
5 Fluorouracil (5 FU) Cream: Intravaginal topical chemotherapy, 5-fluorouracil cream
|
Placebo Cream: Prior to Treatment (Weeks 0-4)
n=90 participants at risk
Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
Placebo: Intravaginal topical placebo cream
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
2/90 • Number of events 7 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Immune system disorders
Anaphylactic reaction
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Bacterial vaginosis
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Bartholin's gland infection
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Candidiasis
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Chlamydial infection
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Folliculitis
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Genital herpes
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
4.4%
4/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Influenza like illness
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Lymphogranuloma venereum
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Skin infection
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Soft tissue infection
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
4/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
3/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Nervous system disorders
Dizziness
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Nervous system disorders
Headache
|
4.4%
4/90 • Number of events 6 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
6.7%
6/90 • Number of events 6 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Nervous system disorders
Oral dysaesthesia
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Renal and urinary disorders
Dysuria
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Cervical erythema
|
58.9%
53/90 • Number of events 68 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
41.1%
37/90 • Number of events 45 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Cervical lesion
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Cervical oedema
|
34.4%
31/90 • Number of events 42 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
18.9%
17/90 • Number of events 26 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Dyspareunia
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Haematometra
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
4.4%
4/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
4.4%
4/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
3/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
8.9%
8/90 • Number of events 8 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Postcoital bleeding
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Uterine pain
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
4.4%
4/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal erythema
|
13.3%
12/90 • Number of events 13 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
8.9%
8/90 • Number of events 9 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal laceration
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal lesion
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal oedema
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
3.3%
3/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulval erythema
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulval laceration
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulval lesion
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulval pain
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.4%
4/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
5.6%
5/90 • Number of events 5 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Reproductive system and breast disorders
Vulvovaginitis
|
16.7%
15/90 • Number of events 18 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
15.6%
14/90 • Number of events 15 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 2 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Skin and subcutaneous tissue disorders
Acneiform dermatitis
|
3.3%
3/90 • Number of events 4 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Skin and subcutaneous tissue disorders
Rash papulopustular
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
1.1%
1/90 • Number of events 1 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
|
Skin and subcutaneous tissue disorders
Vulval rash
|
3.3%
3/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
2.2%
2/90 • Number of events 3 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
0.00%
0/90 • Adverse events (AEs) were reported from first dose of study treatment (Week 4) through study exit at Week 24, or for approximately 20 weeks. AEs occurring before the first dose was administered (weeks 0 to 4) were also recorded and are reported in separate arms/groups.
AEs were ascertained through participant symptom diaries and through clinical exams conducted at study weeks 0, 2, 4, 6, 10, 18 and 24. Unscheduled visits may also have been conducted outside of these study visits to monitor and treat existing or emergent AEs. If there was any change in grade severity for a given AE, the AE was separated into distinct events.
|
Additional Information
Cheryl Hendrickson
University of North Carolina at Chapel Hill
Phone: +1(919)843-2541
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place