Trial Outcomes & Findings for Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (NCT NCT01144416)
NCT ID: NCT01144416
Last Updated: 2022-02-03
Results Overview
Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1424 participants
Primary outcome timeframe
Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.
Results posted on
2022-02-03
Participant Flow
Women, aged between 35 and 42 years, with an indication for controlled ovarian stimulation and in vitro fertilization/intracytoplasmic sperm injection without a history of previous hyper or low ovarian response to follicle-stimulating hormone/human menopausal gonadotropins, ovarian hyperstimulation syndrome (OHSS), or polycystic ovary syndrome.
1424 participants were originally enrolled in the study. All data for 1 participant, who was incorrectly randomized and did not receive study medication and for all 33 participants at 1 clinical site were excluded from all analyses, including disposition, prior to unblinding. Only women who became pregnant continued into Pregnancy Follow-up period.
Participant milestones
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
|
Daily 300 IU recFSH
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Intervention Period
STARTED
|
694
|
696
|
|
Intervention Period
COMPLETED
|
632
|
647
|
|
Intervention Period
NOT COMPLETED
|
62
|
49
|
|
Pregnancy Follow-up Period
STARTED
|
154
|
167
|
|
Pregnancy Follow-up Period
COMPLETED
|
146
|
157
|
|
Pregnancy Follow-up Period
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
|
Daily 300 IU recFSH
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Intervention Period
Adverse Event
|
5
|
6
|
|
Intervention Period
Insufficient ovarian response
|
11
|
17
|
|
Intervention Period
Risk of OHSS
|
0
|
1
|
|
Intervention Period
Too high ovarian response
|
4
|
2
|
|
Intervention Period
No/too few/bad oocytes
|
7
|
5
|
|
Intervention Period
No or abnormal fertilization
|
25
|
10
|
|
Intervention Period
No/too few/bad quality embryos
|
3
|
3
|
|
Intervention Period
Other
|
7
|
5
|
Baseline Characteristics
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Baseline characteristics by cohort
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=694 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=696 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
Total
n=1390 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
38.0 years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
38.0 years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
694 Participants
n=99 Participants
|
696 Participants
n=107 Participants
|
1390 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.Population: Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.
Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
Outcome measures
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=694 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=696 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Percentage of Participants With a Vital Pregnancy
|
23.9 percentage of participants
|
26.9 percentage of participants
|
SECONDARY outcome
Timeframe: Maximally 21 days after the start of study treatment.Population: Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval.
The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).
Outcome measures
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=694 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=696 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Number of Oocytes Retrieved Per Attempt
|
10.7 Number of oocytes
Standard Deviation 7.2
|
10.3 Number of oocytes
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Approximately nine months after embryo transferPopulation: Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to.
The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.
Outcome measures
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=694 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=696 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Live Birth Rate
|
21.3 Percentage of participants
|
23.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 1 month after oocyte pick-upPopulation: All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.
Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.
Outcome measures
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=692 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=698 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Up to time of embryo transfer (maximum of 24 days after start of study drug)Population: All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.
The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.
Outcome measures
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=692 Participants
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=698 Participants
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
|
|---|---|---|
|
Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event
|
5 participants
|
6 participants
|
Adverse Events
Single Injection of 150 µg SCH 900962/MK-8962
Serious events: 4 serious events
Other events: 267 other events
Deaths: 0 deaths
Daily 300 IU recFSH
Serious events: 19 serious events
Other events: 262 other events
Deaths: 0 deaths
Single Injection of 150 µg SCH 900962/MK-8962-Follow-up
Serious events: 110 serious events
Other events: 94 other events
Deaths: 0 deaths
Daily 300 IU recFSH -Follow-up
Serious events: 112 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=692 participants at risk
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=698 participants at risk
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
|
Single Injection of 150 µg SCH 900962/MK-8962-Follow-up
n=154 participants at risk
Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
|
Daily 300 IU recFSH -Follow-up
n=167 participants at risk
Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
|
|---|---|---|---|---|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
ABORTION INFECTED
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.14%
1/692 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
HEMIANOPIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.43%
3/692 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.1%
8/698 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
OVARIAN HYPERSTIMULATION SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.72%
5/698 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
INFECTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Cardiac disorders
BRADYCARDIA NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Cardiac disorders
FOETAL HEART RATE DECELERATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Cardiac disorders
VENTRICULAR HYPERTROPHY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
ACCESSORY AURICLE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
ANKYLOGLOSSIA CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
ARNOLD-CHIARI MALFORMATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
BRAIN MALFORMATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CHORDEE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL AORTIC ANOMALY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL CARDIOVASCULAR ANOMALY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL CHOROID PLEXUS CYST
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL CYSTIC DISEASE OF LIVER
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL GENITAL MALFORMATION MALE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL HYDRONEPHROSIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL HYPOTHYROIDISM
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL INGUINAL HERNIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL MELANOCYTIC NAEVUS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL ORAL MALFORMATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL PIGMENTATION DISORDER
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL PYELOCALIECTASIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
CONGENITAL TORTICOLLIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
DACRYOSTENOSIS CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.4%
4/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
DEAFNESS CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
DERMOID CYST
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
DYSMORPHISM
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
EXOMPHALOS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.2%
5/154 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.8%
3/167 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
FALLOT'S TETRALOGY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
FOETAL CYSTIC HYGROMA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HAEMANGIOMA CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HIGH ARCHED PALATE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HIP DYSPLASIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HOODED PREPUCE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HYPOPLASTIC LEFT HEART SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
HYPOSPADIAS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
INTESTINAL MALROTATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
LARYNGOMALACIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
PATENT DUCTUS ARTERIOSUS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
PECTUS EXCAVATUM
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
PHIMOSIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
PLAGIOCEPHALY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERY STENOSIS CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
RESPIRATORY TRACT MALFORMATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
SEPTUM PELLUCIDUM AGENESIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
SKULL MALFORMATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
SPINA BIFIDA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TALIPES
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TELANGIECTASIA CONGENITAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TRISOMY 13
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TRISOMY 18
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TRISOMY 21
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
TRISOMY 22
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
URACHAL ABNORMALITY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Congenital, familial and genetic disorders
VENTRICULAR SEPTAL DEFECT
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Eye disorders
RETINAL DETACHMENT
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
FUNCTIONAL GASTROINTESTINAL DISORDER
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
General disorders
TEMPERATURE REGULATION DISORDER
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
CHORIOAMNIONITIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
ENDOMETRITIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
SEPSIS NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Investigations
FOETAL HEART RATE ABNORMAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.9%
6/154 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.0%
5/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Investigations
FOETAL HEART RATE DECREASED
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Investigations
FOETAL NON-STRESS TEST ABNORMAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Metabolism and nutrition disorders
FEEDING DISORDER NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Metabolism and nutrition disorders
KETOACIDOSIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Musculoskeletal and connective tissue disorders
RETROGNATHIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
CEREBRAL VENTRICLE DILATATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.8%
3/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
INTRAVENTRICULAR HAEMORRHAGE NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
ARRESTED LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.4%
16/154 • Number of events 16 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
7.8%
13/167 • Number of events 13 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
BREECH PRESENTATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
7.8%
12/154 • Number of events 12 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
14/167 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
CEPHALO-PELVIC DISPROPORTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
CERVICAL INCOMPETENCE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
DISCORDANT TWIN
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FAILED INDUCTION OF LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DEATH
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL DISTRESS SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL GROWTH RESTRICTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL MACROSOMIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.8%
3/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
FOETAL MALPRESENTATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL HYPERTENSION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.8%
3/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
HAEMORRHAGE IN PREGNANCY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
HELLP SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
JAUNDICE NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
LOW BIRTH WEIGHT BABY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
MECONIUM IN AMNIOTIC FLUID
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
MULTIPLE PREGNANCY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
OLIGOHYDRAMNIOS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.4%
4/167 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PERIPARTUM CARDIOMYOPATHY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PLACENTA PRAEVIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.0%
5/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PLACENTA PRAEVIA HAEMORRHAGE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
POSTPARTUM HAEMORRHAGE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PRE-ECLAMPSIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.5%
7/154 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.2%
7/167 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY WITH ADVANCED MATERNAL AGE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.7%
15/154 • Number of events 25 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.2%
17/167 • Number of events 28 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.8%
8/167 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE RUPTURE OF MEMBRANES
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE SEPARATION OF PLACENTA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREVIOUS CAESAREAN SECTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
7.1%
11/154 • Number of events 11 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
14/167 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PROLONGED PREGNANCY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
RETAINED PLACENTA OR MEMBRANES
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
SMALL FOR DATES BABY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
STILLBIRTH
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
THREATENED LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
TRANSVERSE PRESENTATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.3%
2/154 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
TWIN PREGNANCY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.5%
10/154 • Number of events 10 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.6%
11/167 • Number of events 11 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
UMBILICAL CORD AROUND NECK
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
UTERINE CERVICAL LACERATION DURING LABOUR
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
VASA PRAEVIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
WEIGHT DECREASE NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Renal and urinary disorders
BLADDER DYSFUNCTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
CERVIX DISORDER
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
CERVIX OEDEMA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
PELVIC PROLAPSE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
SHORTENED CERVIX
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.8%
3/167 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY DYSPLASIA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
IMMATURE RESPIRATORY SYSTEM
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
INFANTILE APNOEIC ATTACK
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL ASPIRATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.5%
7/154 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY FAILURE
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
TRANSIENT TACHYPNOEA OF THE NEWBORN
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.9%
3/154 • Number of events 3 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Surgical and medical procedures
CAESAREAN SECTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.2%
8/154 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.0%
5/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Surgical and medical procedures
MYOMECTOMY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.4%
4/167 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Surgical and medical procedures
SELECTIVE ABORTION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.65%
1/154 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.2%
2/167 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.60%
1/167 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
Other adverse events
| Measure |
Single Injection of 150 µg SCH 900962/MK-8962
n=692 participants at risk
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
|
Daily 300 IU recFSH
n=698 participants at risk
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
|
Single Injection of 150 µg SCH 900962/MK-8962-Follow-up
n=154 participants at risk
Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
|
Daily 300 IU recFSH -Follow-up
n=167 participants at risk
Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
6.8%
47/692 • Number of events 50 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.7%
33/698 • Number of events 36 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.5%
10/154 • Number of events 10 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.0%
15/167 • Number of events 15 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
8.8%
61/692 • Number of events 64 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.9%
69/698 • Number of events 72 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.2%
5/154 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.4%
4/167 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
14.2%
98/692 • Number of events 101 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
11.9%
83/698 • Number of events 86 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
13/154 • Number of events 15 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.8%
18/167 • Number of events 20 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Nervous system disorders
HEADACHE
|
10.5%
73/692 • Number of events 98 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.5%
73/698 • Number of events 101 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.9%
6/154 • Number of events 10 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.6%
11/167 • Number of events 11 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
4.2%
29/692 • Number of events 29 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.6%
39/698 • Number of events 39 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/154 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/167 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Reproductive system and breast disorders
PELVIC DISCOMFORT
|
7.5%
52/692 • Number of events 57 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.2%
57/698 • Number of events 66 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.6%
4/154 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.6%
6/167 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.0%
21/692 • Number of events 23 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.2%
22/698 • Number of events 22 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
11.0%
17/154 • Number of events 19 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
12.0%
20/167 • Number of events 24 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.58%
4/692 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.0%
14/698 • Number of events 15 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.8%
9/154 • Number of events 13 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.2%
17/167 • Number of events 17 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.58%
4/692 • Number of events 4 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.29%
2/698 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.8%
9/154 • Number of events 11 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.8%
8/167 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.29%
2/692 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
10.4%
16/154 • Number of events 17 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.0%
15/167 • Number of events 18 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.0%
14/692 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
1.0%
7/698 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.8%
9/154 • Number of events 9 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
3.0%
5/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Injury, poisoning and procedural complications
PERINEAL LACERATION
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.2%
8/154 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
14/167 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
AFTERBIRTH PAIN
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
7.1%
11/154 • Number of events 13 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.6%
11/167 • Number of events 12 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
GESTATIONAL DIABETES
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.7%
15/154 • Number of events 16 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
14/167 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
JAUNDICE NEONATAL
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
20.1%
31/154 • Number of events 33 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
16.2%
27/167 • Number of events 30 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
9.1%
14/154 • Number of events 20 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.0%
10/167 • Number of events 13 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Pregnancy, puerperium and perinatal conditions
VOMITING IN PREGNANCY
|
3.6%
25/692 • Number of events 28 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.4%
31/698 • Number of events 35 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
6.5%
10/154 • Number of events 11 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.4%
9/167 • Number of events 9 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.87%
6/692 • Number of events 6 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.29%
2/698 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.8%
9/154 • Number of events 9 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.8%
8/167 • Number of events 8 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Respiratory, thoracic and mediastinal disorders
NEONATAL RESPIRATORY DISTRESS SYNDROME
|
0.00%
0/692 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.00%
0/698 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
5.2%
8/154 • Number of events 9 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
2.4%
4/167 • Number of events 5 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.29%
2/692 • Number of events 2 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
0.14%
1/698 • Number of events 1 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
4.5%
7/154 • Number of events 7 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
8.4%
14/167 • Number of events 14 • Adverse events (AEs) were reported for both pretreatment and active treatment periods of the Intervention Phase of the study, inclusive. AEs for the Follow-up Period include events reported by the mother/fetus/infant (up to 4-12 weeks after birth).
Safety Population: All Subjects Treated, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received. Three participants randomized to SCH900962 were treated with recFSH, and 1 participant randomized to recFSH was treated with SCH900962.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agreed not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agreed to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report(s) any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER