Phase III Study Comparing Efficacy and Safety of AFOLIA v... | NCT01687712

Label	Type	Description	Intervention Names
AFOLIA	Experimental	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	Drug: AFOLIA
Gonal-f® RFF	Active Comparator	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	Drug: Gonal-f® RFF

Name	Type	Description	Arm Group Labels	Other Names
AFOLIA	Drug	225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Measure	Description	Time Frame
Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population	Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.	Six weeks post embryo transfer
Clinical Pregnancy Rate After One Cycle of Treatment - PP Population	Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.	Six weeks post embryo transfer

Measure	Description	Time Frame
Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1	The number of days of r-hFSH stimulation a subject received during Cycle 1.	Measured at discretionary visits between Days 9 and 15 after FSH starts
Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1

Name	Affiliation	Role
Julian Jenkins, DM FRCOG	Fertility Biotech AG	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Physicians Research Group		Tempe	Arizona	85284	United States
HRC Fertility

ID	Title	Description
FG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
FG001	Gonal-f® RFF

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population

Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.

Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Six weeks post embryo transfer

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants	OG000549 OG001551

Title

Denominators

Categories

Title	Measurements
Yes	OG000114 OG001138
No	OG000435

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null and alternative hypotheses are as follows: H0: p2- p1 > ∆ and H1: p2- p1 ≤ ∆, where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%.					Risk Difference (RD)	3.7			2-Sided	95	-1.3	8.7			Note that "risk" in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA.		Non-Inferiority	Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.

Primary

Clinical Pregnancy Rate After One Cycle of Treatment - PP Population

Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).

Posted

Count of Participants

Participants

Six weeks post embryo transfer

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Secondary

Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1

The number of days of r-hFSH stimulation a subject received during Cycle 1.

Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Mean

Standard Deviation

days

Measured at discretionary visits between Days 9 and 15 after FSH starts

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1

The total dose of r-hFSH that subjects received during Cycle 1.

Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Mean

Standard Deviation

international unit (IU)

Measured at discretionary visits between Days 9 and 15 after FSH starts.

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1

The mean dose of r-hFSH that subjects received in a day during Cycle 1.

Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Mean

Standard Deviation

international unit (IU)

Measured at discretionary visits between Days 9 and 15 after FSH starts.

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Number of Oocytes Retrieved - Cycle 1

The number of oocytes retrieved per subject, following hCG administration in Cycle 1.

Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Mean

Standard Deviation

Oocytes retrieved

Visit 8, 34-36 hours after hCG administration

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1

Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1

Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Overall Summary of Adverse Events (AEs) - Cycle 1

Summary of AEs, including the number of subjects experiencing to following during Cycle 1:

At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Secondary

Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1

Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2

Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3

Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.

Posted

Count of Participants

Participants

Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Units	Counts
Participants

Secondary

Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1

Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.

Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.

Posted

Count of Participants

Participants

Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Secondary

Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2

Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Secondary

Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3

Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.

Posted

Count of Participants

Participants

ID	Title	Description
OG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
OG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.

Serious Adverse Events

Term	Organ System	Notes	Statistical Information
Foetal heart rate deceleration	Cardiac disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG0030 affected120 at risk EG0040 affected28 at risk EG0050 affected24 at risk
Accessory auricle	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Cardiac septal defect	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Cleft palate	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Congenital skin dimples	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Cytogenetic abnormality	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Foetal chromosome abnormality	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Hypospadias	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Mosaicism	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Patent ductus arteriosus	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Polydactyly	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 13	Congenital, familial and genetic disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 15	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 17	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 21	Congenital, familial and genetic disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 22	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Trisomy 9	Congenital, familial and genetic disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Turner's syndrome	Congenital, familial and genetic disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Gastritis	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Death neonatal	General disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Pyrexia	General disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Acute fatty liver of pregnancy	Hepatobiliary disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Cholestasis	Hepatobiliary disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Fall	Injury, poisoning and procedural complications		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Procedural pain	Injury, poisoning and procedural complications		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions		EG0002 affected549 at risk EG0015 affected551 at risk EG0020 affected109 at risk EG003
Cervical incompetence	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Foetal death	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0011 affected551 at risk EG0021 affected109 at risk EG003
Foetal growth restriction	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Gestational hypertension	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Heterotopic pregnancy	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Postpartum haemorrhage	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Premature baby	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Premature labour	Pregnancy, puerperium and perinatal conditions		EG0003 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions		EG0004 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Prolonged labour	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Transverse presentation	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Umbilical cord abnormality	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Vanishing twin syndrome	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.	EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Abortion induced	Surgical and medical procedures		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hypertension	Vascular disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003

Other Adverse Events

Term	Organ System	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG0030 affected120 at risk EG0040 affected28 at risk EG0050 affected24 at risk
Palpitations	Cardiac disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Ear discomfort	Ear and labyrinth disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ear pain	Ear and labyrinth disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Vertigo	Ear and labyrinth disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0021 affected109 at risk EG003
Hypothyroidism	Endocrine disorders		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Asthenopia	Eye disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Conjunctivitis	Eye disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Dry eye	Eye disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Eye irritation	Eye disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Vision blurred	Eye disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Abdominal discomfort	Gastrointestinal disorders		EG0005 affected549 at risk EG00110 affected551 at risk EG0022 affected109 at risk EG003
Abdominal distension	Gastrointestinal disorders		EG00049 affected549 at risk EG00142 affected551 at risk EG0027 affected109 at risk EG003
Abdominal pain	Gastrointestinal disorders		EG00046 affected549 at risk EG00154 affected551 at risk EG0027 affected109 at risk EG003
Abdominal pain lower	Gastrointestinal disorders		EG0004 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Abdominal pain upper	Gastrointestinal disorders		EG0003 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Abdominal tenderness	Gastrointestinal disorders		EG0007 affected549 at risk EG0015 affected551 at risk EG0020 affected109 at risk EG003
Ascites	Gastrointestinal disorders		EG0004 affected549 at risk EG0013 affected551 at risk EG0021 affected109 at risk EG003
Constipation	Gastrointestinal disorders		EG00016 affected549 at risk EG00115 affected551 at risk EG0024 affected109 at risk EG003
Dental caries	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Diarrhoea	Gastrointestinal disorders		EG00013 affected549 at risk EG00110 affected551 at risk EG0024 affected109 at risk EG003
Dry mouth	Gastrointestinal disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Dyspepsia	Gastrointestinal disorders		EG0008 affected549 at risk EG0019 affected551 at risk EG0021 affected109 at risk EG003
Flatulence	Gastrointestinal disorders		EG0003 affected549 at risk EG00111 affected551 at risk EG0020 affected109 at risk EG003
Gingival bleeding	Gastrointestinal disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Gingival pain	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Glossodynia	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Haemorrhoids	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hypoaesthesia oral	Gastrointestinal disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Lip pain	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Localised intraabdominal fluid collection	Gastrointestinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Nausea	Gastrointestinal disorders		EG00053 affected549 at risk EG00155 affected551 at risk EG0028 affected109 at risk EG003
Vomiting	Gastrointestinal disorders		EG00011 affected549 at risk EG00114 affected551 at risk EG0021 affected109 at risk EG003
Adverse drug reaction	General disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Asthenia	General disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Chest discomfort	General disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Chills	General disorders		EG0001 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Crying	General disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Discomfort	General disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Fatigue	General disorders		EG00013 affected549 at risk EG00114 affected551 at risk EG0022 affected109 at risk EG003
Feeling hot	General disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Inflammation	General disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Injection site bruising	General disorders		EG0006 affected549 at risk EG0018 affected551 at risk EG0021 affected109 at risk EG003
Injection site erythema	General disorders		EG00082 affected549 at risk EG00176 affected551 at risk EG00211 affected109 at risk EG003
Injection site haematoma	General disorders		EG0003 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Injection site haemorrhage	General disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Injection site inflammation	General disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Injection site pain	General disorders		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Injection site pruritus	General disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Injection site reaction	General disorders		EG0007 affected549 at risk EG0017 affected551 at risk EG0021 affected109 at risk EG003
Injection site scab	General disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Injection site swelling	General disorders		EG0008 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Injection site vesicles	General disorders		EG0003 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Irritability	General disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Local swelling	General disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Malaise	General disorders		EG0002 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Non-cardiac chest pain	General disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Pain	General disorders		EG0000 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Pyrexia	General disorders		EG0002 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Vessel puncture site pain	General disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Drug hypersensitivity	Immune system disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Seasonal allergy	Immune system disorders		EG0003 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Body tinea	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ear infection	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Folliculitis	Infections and infestations		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Fungal infection	Infections and infestations		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Gastroenteritis viral	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Genital herpes	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Herpes simplex	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Infected bites	Infections and infestations		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Influenza	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Nasopharyngitis	Infections and infestations		EG0009 affected549 at risk EG0016 affected551 at risk EG0021 affected109 at risk EG003
Oral herpes	Infections and infestations		EG0000 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Pharyngitis streptococcal	Infections and infestations		EG0000 affected549 at risk EG0011 affected551 at risk EG0021 affected109 at risk EG003
Salpingitis	Infections and infestations		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Sinusitis	Infections and infestations		EG0002 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Upper respiratory tract infection	Infections and infestations		EG0003 affected549 at risk EG0013 affected551 at risk EG0021 affected109 at risk EG003
Urinary tract infection	Infections and infestations		EG0004 affected549 at risk EG0013 affected551 at risk EG0021 affected109 at risk EG003
Vaginitis bacterial	Infections and infestations		EG0000 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Contusion	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Limb injury	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Muscle strain	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Post procedural discomfort	Injury, poisoning and procedural complications		EG00039 affected549 at risk EG00136 affected551 at risk EG0028 affected109 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications		EG0004 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications		EG0002 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Procedural nausea	Injury, poisoning and procedural complications		EG00015 affected549 at risk EG00115 affected551 at risk EG0022 affected109 at risk EG003
Procedural pain	Injury, poisoning and procedural complications		EG000105 affected549 at risk EG00189 affected551 at risk EG00213 affected109 at risk EG003
Procedural vomiting	Injury, poisoning and procedural complications		EG0002 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Blood oestrogen increased	Investigations		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Blood pressure increased	Investigations		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Blood urine present	Investigations		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Body temperature increased	Investigations		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Haemoglobin decreased	Investigations		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Heart rate increased	Investigations		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hepatic enzyme increased	Investigations		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Infertility tests	Investigations		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Weight decreased	Investigations		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Weight increased	Investigations		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Decreased appetite	Metabolism and nutrition disorders		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders		EG0002 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders		EG0009 affected549 at risk EG00121 affected551 at risk EG0021 affected109 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders		EG0002 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Limb discomfort	Musculoskeletal and connective tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders		EG0009 affected549 at risk EG00116 affected551 at risk EG0020 affected109 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders		EG0004 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders		EG0002 affected549 at risk EG0013 affected551 at risk EG0021 affected109 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Aphonia	Nervous system disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Dizziness	Nervous system disorders		EG00010 affected549 at risk EG0017 affected551 at risk EG0022 affected109 at risk EG003
Dysgeusia	Nervous system disorders		EG0002 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Headache	Nervous system disorders		EG000145 affected549 at risk EG001127 affected551 at risk EG00214 affected109 at risk EG003
Hyperaesthesia	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Lethargy	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Migraine	Nervous system disorders		EG0000 affected549 at risk EG0017 affected551 at risk EG0021 affected109 at risk EG003
Migraine with aura	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Nerve compression	Nervous system disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Paraesthesia	Nervous system disorders		EG0003 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Poor quality sleep	Nervous system disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Presyncope	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Retinal migraine	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Sciatica	Nervous system disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Sinus headache	Nervous system disorders		EG0004 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Somnolence	Nervous system disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Syncope	Nervous system disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Tension headache	Nervous system disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Abortion early	Pregnancy, puerperium and perinatal conditions		EG00043 affected549 at risk EG00160 affected551 at risk EG00218 affected109 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions		EG0007 affected549 at risk EG0019 affected551 at risk EG0020 affected109 at risk EG003
Cervical incompetence	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions		EG0003 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Gestational diabetes	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Haemorrhage in pregnancy	Pregnancy, puerperium and perinatal conditions		EG0002 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Placenta praevia	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Retained placenta or membranes	Pregnancy, puerperium and perinatal conditions		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Subchorionic haematoma	Pregnancy, puerperium and perinatal conditions		EG0002 affected549 at risk EG0015 affected551 at risk EG0020 affected109 at risk EG003
Subchorionic haemorrhage	Pregnancy, puerperium and perinatal conditions		EG0003 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Vanishing twin syndrome	Pregnancy, puerperium and perinatal conditions		EG0001 affected549 at risk EG0016 affected551 at risk EG0020 affected109 at risk EG003
Vomiting in pregnancy	Pregnancy, puerperium and perinatal conditions		EG0002 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Anxiety	Psychiatric disorders		EG0004 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Depressed mood	Psychiatric disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Depression	Psychiatric disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Emotional disorder	Psychiatric disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Insomnia	Psychiatric disorders		EG0007 affected549 at risk EG0014 affected551 at risk EG0021 affected109 at risk EG003
Mood altered	Psychiatric disorders		EG0002 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Mood swings	Psychiatric disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Nightmare	Psychiatric disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Restlessness	Psychiatric disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Dysuria	Renal and urinary disorders		EG0004 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Haematuria	Renal and urinary disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Micturition urgency	Renal and urinary disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Pollakiuria	Renal and urinary disorders		EG0003 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Urinary retention	Renal and urinary disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Adnexa uteri pain	Reproductive system and breast disorders		EG0007 affected549 at risk EG0013 affected551 at risk EG0021 affected109 at risk EG003
Breast mass	Reproductive system and breast disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Breast pain	Reproductive system and breast disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Breast tenderness	Reproductive system and breast disorders		EG00012 affected549 at risk EG0018 affected551 at risk EG0020 affected109 at risk EG003
Cervical discharge	Reproductive system and breast disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Cervical polyp	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Coital bleeding	Reproductive system and breast disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders		EG0004 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Fallopian tube cyst	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hypomenorrhoea	Reproductive system and breast disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Menorrhagia	Reproductive system and breast disorders		EG0001 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Nipple pain	Reproductive system and breast disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ovarian cyst	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Ovarian enlargement	Reproductive system and breast disorders		EG0003 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ovarian hyperstimulation syndrome	Reproductive system and breast disorders	Note: This includes subjects who were at risk of OHSS as well those who had actual OHSS.	EG00016 affected549 at risk EG00112 affected551 at risk EG0023 affected109 at risk EG003
Pelvic discomfort	Reproductive system and breast disorders		EG0008 affected549 at risk EG00110 affected551 at risk EG0021 affected109 at risk EG003
Pelvic pain	Reproductive system and breast disorders		EG0002 affected549 at risk EG0016 affected551 at risk EG0020 affected109 at risk EG003
Uterine cervix stenosis	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Uterine pain	Reproductive system and breast disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Uterine polyp	Reproductive system and breast disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0021 affected109 at risk EG003
Uterine spasm	Reproductive system and breast disorders		EG0008 affected549 at risk EG0019 affected551 at risk EG0022 affected109 at risk EG003
Vaginal discharge	Reproductive system and breast disorders		EG0002 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders		EG00014 affected549 at risk EG00119 affected551 at risk EG0021 affected109 at risk EG003
Vaginal odour	Reproductive system and breast disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Vulvovaginal discomfort	Reproductive system and breast disorders		EG0001 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Vulvovaginal pruritus	Reproductive system and breast disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders		EG0002 affected549 at risk EG0013 affected551 at risk EG0020 affected109 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders		EG0003 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders		EG00011 affected549 at risk EG00110 affected551 at risk EG0020 affected109 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders		EG00010 affected549 at risk EG00115 affected551 at risk EG0022 affected109 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0021 affected109 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders		EG0003 affected549 at risk EG0016 affected551 at risk EG0022 affected109 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders		EG0002 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders		EG0003 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Acne	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Blood blister	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders		EG0002 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders		EG0000 affected549 at risk EG0012 affected551 at risk EG0020 affected109 at risk EG003
Rash	Skin and subcutaneous tissue disorders		EG0003 affected549 at risk EG0014 affected551 at risk EG0020 affected109 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Abortion induced	Surgical and medical procedures		EG0002 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Sinus operation	Surgical and medical procedures		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Tooth extraction	Surgical and medical procedures		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Uterine dilation and curettage	Surgical and medical procedures		EG0000 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Diastolic hypotension	Vascular disorders		EG0000 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Flushing	Vascular disorders		EG0001 affected549 at risk EG0011 affected551 at risk EG0020 affected109 at risk EG003
Hot flush	Vascular disorders		EG00011 affected549 at risk EG0018 affected551 at risk EG0021 affected109 at risk EG003
Hypertension	Vascular disorders		EG0001 affected549 at risk EG0010 affected551 at risk EG0020 affected109 at risk EG003
Hypotension	Vascular disorders		EG0000 affected549 at risk EG0010 affected551 at risk EG0021 affected109 at risk EG003

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D006063	Chorionic Gonadotropin
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D005640	Follicle Stimulating Hormone
D006065	Gonadotropins, Pituitary
D007986	Luteinizing Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D013972	Thyrotropin
D010926	Placental Hormones
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	AFOLIA	One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
BG001	Gonal-f® RFF	One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AFOLIA - Cycle 1	Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	0	549	32	549	403	549
EG001	Gonal-f® RFF - Cycle 1	Enrolled subjects in Cycle 1 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	1	551	31	551	391	551
EG002	AFOLIA - Cycle 2	Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	0	109	2	109	69	109
EG003	Gonal-f® RFF - Cycle 2	Enrolled subjects in Cycle 2 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	0	120	6	120	66	120
EG004	AFOLIA - Cycle 3	Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	0	28	3	28	13	28
EG005	Gonal-f® RFF - Cycle 3	Enrolled subjects in Cycle 3 were randomized to one subcutaneous injection of 225IU Gonal-f (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.	0	24	0	24	12	24