Trial Outcomes & Findings for Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel (NCT NCT01306331)

Last Updated: 2022-07-12

Results Overview

The primary endpoint was the evaluation of contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the MITT population by treatment group

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3389 participants

Primary outcome timeframe

183 days

Results posted on

2022-07-12

Participant Flow

Healthy, sexually active women at risk of pregnancy who desired contraception, aged 18 to 35 years, with a single male sex partner, of which both partners were at low risk for HIV and sexually transmitted disease (STD) infection. Subjects were required to have regular, normal, cyclic menses with a usual length of 21 to 40 days.

The study had 65 randomized screen failures and were not included in the ITT population due to being accidentally randomized (30 randomized to Amphora™ Gel and 35 to Conceptrol®).

Participant milestones

Participant milestones
Measure	Conceptrol 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Overall Study STARTED	1659	1665
Overall Study COMPLETED	758	788
Overall Study NOT COMPLETED	901	877

Reasons for withdrawal

Reasons for withdrawal
Measure	Conceptrol 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Overall Study Adverse Event	28	25
Overall Study Lost to Follow-up	321	323
Overall Study Physician Decision	26	22
Overall Study Pregnancy	136	151
Overall Study Protocol Violation	154	124
Overall Study Withdrawal by Subject	163	152
Overall Study Not sexually active	29	28
Overall Study Meth. no longer prim. meth. birth cntrl	10	20
Overall Study Other	34	32

Baseline Characteristics

Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conceptrol n=1659 Participants 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora n=1665 Participants Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.	Total n=3324 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	385 Participants n=5 Participants	392 Participants n=7 Participants	777 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1274 Participants n=5 Participants	1272 Participants n=7 Participants	2546 Participants n=5 Participants
Race (NIH/OMB) More than one race	98 Participants n=5 Participants	102 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Asian	45 Participants n=5 Participants	36 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Black or African American	464 Participants n=5 Participants	471 Participants n=7 Participants	935 Participants n=5 Participants
Race (NIH/OMB) White	1030 Participants n=5 Participants	1031 Participants n=7 Participants	2061 Participants n=5 Participants
Age, Continuous	27.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	27.6 years STANDARD_DEVIATION 5.6 • n=7 Participants	27.6 years STANDARD_DEVIATION 5.64 • n=5 Participants
Sex: Female, Male Female	1659 Participants n=5 Participants	1665 Participants n=7 Participants	3324 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
BMI Category at Enrollment (kg/m2) Underweight (<18.5)	75 Participants n=5 Participants	83 Participants n=7 Participants	158 Participants n=5 Participants
BMI Category at Enrollment (kg/m2) Normal (18.5 - 24.9)	672 Participants n=5 Participants	640 Participants n=7 Participants	1312 Participants n=5 Participants
BMI Category at Enrollment (kg/m2) Overweight (25.0 - 29.9)	369 Participants n=5 Participants	392 Participants n=7 Participants	761 Participants n=5 Participants
BMI Category at Enrollment (kg/m2) Obese (>30.0)	539 Participants n=5 Participants	548 Participants n=7 Participants	1087 Participants n=5 Participants
BMI at Enrollment (kg/m2)	27.76 kg/m2 STANDARD_DEVIATION 7.98 • n=5 Participants	27.91 kg/m2 STANDARD_DEVIATION 7.95 • n=7 Participants	27.83 kg/m2 STANDARD_DEVIATION 7.97 • n=5 Participants

PRIMARY outcome

Timeframe: 183 days

Population: mITT Population - ITT subjects whose diaries indicated they had at least one episode of coitus while using the assigned study product (also referred as "Typical-Use"), between 18 to 35 years of age (inclusive) at enrollment, had at least 1 cycle without any backup contraception or EC, and for whom there was at least one report of pregnancy status.

Outcome measures

Outcome measures
Measure	Conceptrol n=1281 Participants 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora n=1259 Participants Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
6-Month (183 Days) Cumulative Pregnancy Percentage	10.0 pregnancy percentage Interval 8.1 to 11.9	10.5 pregnancy percentage Interval 8.6 to 12.3

SECONDARY outcome

Timeframe: 183 days

Population: EE populations - a subset of the MITT population that includes only subjects with at least one EE cycle, where an EE cycle is a cycle where the diaries indicated they used the product correctly for every act of intercourse in the cycle.

Perfect use contraceptive efficacy over six months (183 days) of Amphora™ Gel use when compared to Conceptrol® Vaginal Gel. Kaplan-Meier methods were used to estimate the six-month cumulative pregnancy percentage of women in the efficacy evaluable (EE) population by treatment group

Outcome measures

Outcome measures
Measure	Conceptrol n=1161 Participants 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora n=1161 Participants Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
6-Month (183 Days) Cumulative Pregnancy Percentage for Subjects With Perfect Use	4.2 pregnancy percentage Interval 2.8 to 5.6	4.1 pregnancy percentage Interval 2.7 to 5.4

Adverse Events

Conceptrol

Serious events: 19 serious events

Other events: 857 other events

Deaths: 0 deaths

Amphora

Serious events: 11 serious events

Other events: 793 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Conceptrol n=1477 participants at risk 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora n=1458 participants at risk Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Infections and infestations Urinary Tract Infection	13.1% 193/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	9.6% 140/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Vaginitis Bacterial	11.5% 170/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	11.0% 160/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Vulvovaginal Mycotic	11.4% 168/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	10.7% 156/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Nervous system disorders Headache	5.4% 80/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	6.6% 96/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Vulvovaginal Pruritus	5.1% 76/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	3.8% 55/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Nasopharyngitis	3.2% 48/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	5.2% 76/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Vulvovaginal Discomfort	3.6% 53/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	2.9% 42/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Vulvovaginal	3.1% 46/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	3.1% 45/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Vulvovaginal Burning Sensation	2.8% 41/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	3.4% 49/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Vaginal Discharge	3.1% 46/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	2.9% 43/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Dysmenorrhoea	2.3% 34/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	2.3% 33/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations nfluenza	1.4% 20/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	2.5% 37/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Investigations Smear Cervix Abnormal	2.0% 29/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	1.4% 21/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Renal and urinary disorders Dysuria	2.0% 30/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	1.4% 20/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.

Additional Information

Clinical Operations

Evofem

Phone: 858-550-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Conceptrol n=1477 participants at risk 100 mg (4% concentration) of nonoxynol-9 in 2.5 mL volume of gel Conceptrol: • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.	Amphora n=1458 participants at risk Citric acid USP, potassium bitartrate USP, and L-lactic acid USP Amphora: • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Cardiac disorders Wolff-Parkison-White syndrome	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Ear and labyrinth disorders Vertigo	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Gastrointestinal disorders Abdominal pain	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Gastrointestinal disorders Pancreatitis	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Gastrointestinal disorders Pancreatitis acute	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Gastrointestinal disorders Non-cardiac chest pain	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Abdominal abscess	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Appendicitis	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Campylobacter gastroenteritis	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Gastroenteritis viral	0.00% 0/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Kidney Infection	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Post procedural sepsis	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Infections and infestations Pyelonephritis	0.14% 2/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.14% 2/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Investigations Investigation	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Nervous system disorders Migraine	0.00% 0/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.20% 3/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Reproductive system and breast disorders Ovarian rupture	0.00% 0/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.07% 1/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.14% 2/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.
Surgical and medical procedures Gastrectomy	0.07% 1/1477 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.	0.00% 0/1458 • 183 days Any untoward medical occurrence in a subject that has been treated with study drug; the untoward medical occurrence did not necessarily have to have a causal relationship with the study treatment; In reference to the total number of participants at risk in the adverse events module, the # at risk was limited to the # of ITT subjects who used at least 1 dose of drug.