Trial Outcomes & Findings for Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710) (NCT NCT00702624)

Last Updated: 2022-02-03

Results Overview

The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.

Recruitment status

COMPLETED

Target enrollment

113 participants

Primary outcome timeframe

From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

Results posted on

2022-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Corifollitropin Alfa 100 μg Women/Expectant Mothers Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women/Expectant Mothers Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.	Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.	recFSH 150 IU Fetuses at 10 Weeks After ET This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
Base Study P05690 (NCT00702845) STARTED	268	128	0	0
Base Study P05690 (NCT00702845) COMPLETED	246	121	0	0
Base Study P05690 (NCT00702845) NOT COMPLETED	22	7	0	0
Expectant Mother Follow-up STARTED	68	45	0	0
Expectant Mother Follow-up COMPLETED	61	45	0	0
Expectant Mother Follow-up NOT COMPLETED	7	0	0	0
Fetuses/Infant Follow-up STARTED	0	0	88	55
Fetuses/Infant Follow-up Live Born Infants	0	0	80	55
Fetuses/Infant Follow-up COMPLETED	0	0	78	55
Fetuses/Infant Follow-up NOT COMPLETED	0	0	10	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Corifollitropin Alfa 100 μg Expectant Mothers n=68 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Expectant Mothers n=45 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.	Total n=113 Participants Total of all reporting groups
Age, Continuous	30.5 Years STANDARD_DEVIATION 3.3 • n=93 Participants	31.3 Years STANDARD_DEVIATION 3.1 • n=4 Participants	30.8 Years STANDARD_DEVIATION 3.2 • n=27 Participants
Sex: Female, Male Female	68 Participants n=93 Participants	45 Participants n=4 Participants	113 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

Population: Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 100 μg Women n=268 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women n=128 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)	23.5 Percentage of participants	34.4 Percentage of participants

PRIMARY outcome

Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 100 μg Women n=68 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women n=45 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Number of Expectant Mothers Experiencing Adverse Events (AEs)	48 Participants	35 Participants

PRIMARY outcome

Timeframe: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

Population: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 100 μg Women n=68 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women n=45 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Number of Expectant Mothers Experiencing Serious AEs (SAEs)	38 Participants	21 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks after birth

Population: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 100 μg Women n=80 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women n=55 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Number of Infants Experiencing AEs	37 Live born infants	27 Live born infants

PRIMARY outcome

Timeframe: Up to 12 weeks after birth

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 100 μg Women n=80 Participants Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Women n=55 Participants Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.
Number of Infants Experiencing SAEs	30 Live born infants	16 Live born infants

Adverse Events

Corifollitropin Alfa 100 μg Expectant Mothers

Serious events: 38 serious events

Other events: 13 other events

Deaths: 0 deaths

recFSH 150 IU Expectant Mothers

Serious events: 21 serious events

Other events: 17 other events

Deaths: 0 deaths

Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET

Serious events: 31 serious events

Other events: 9 other events

Deaths: 0 deaths

recFSH 150 IU Fetuses at 10 Weeks After ET

Serious events: 16 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Corifollitropin Alfa 100 μg Expectant Mothers n=68 participants at risk Participants in base study P05690 received single SC injection of corifollitropin alfa 100 μg (Org 36286) on Day 2 or 3 of menstrual cycle and daily placebo recFSH injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including Day of hCG administration. Participants also received GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including Day of hCG (10,000 or 5,000 IU/USP); and progesterone (at least 600 mg/day vaginally or 50 mg/day by intramuscular \[IM\] injection), starting on day of OPU and continuing at least 6 weeks or up to menses. Eligible participants from base study were enrolled in follow up study P05710, but no study treatments were given.	recFSH 150 IU Expectant Mothers n=45 participants at risk Participants in the reference group in base study P05690 received a single SC injection of placebo-corifollitropin alfa administered on Day 2 or 3 of the menstrual cycle and daily SC recFSH 150 IU injections (7 total) from Stimulation Day 1 up to and including Stimulation Day 7. Participants also received open-label recFSH (up to 200 IU/day) from Stimulation Day 8 onwards, up to and including the Day of hCG administration. Participants also received the GnRH antagonist ganirelix (0.25 mg) once daily SC starting on Stimulation Day 5 up to and including the Day of hCG (10,000 or 5,000 IU/USP). Participants also received progesterone (at least 600 mg/day vaginally or 50 mg/day IM), starting on the Day of OPU and continuing for at least 6 weeks or up to menses. Eligible participants from the base study were enrolled in follow up study P05710, but no study treatments were given.	Corifollitropin Alfa 100 μg Fetuses at 10 Weeks After ET n=88 participants at risk This group includes fetuses of expectant mothers who were administered corifollitropin alfa in base study P05690 (NCT00702845). The fetuses were present at 10 weeks after embryo transfer (ET) in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.	recFSH 150 IU Fetuses at 10 Weeks After ET n=55 participants at risk This group includes fetuses of expectant mothers who were administered recFSH on base study P05690 (NCT00702845). The fetuses were present at 10 weeks after ET in the base study, and expectant mothers were eligible for enrollment in follow up study P05710.
Blood and lymphatic system disorders Anaemia	7.4% 5/68 • Number of events 5 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	13.3% 6/45 • Number of events 6 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
General disorders Pyrexia	5.9% 4/68 • Number of events 4 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/45 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	3.6% 2/55 • Number of events 2 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Pregnancy, puerperium and perinatal conditions Abnormal labour	0.00% 0/68 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	6.7% 3/45 • Number of events 3 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Pregnancy, puerperium and perinatal conditions Antepartum haemorrhage	4.4% 3/68 • Number of events 3 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	8.9% 4/45 • Number of events 4 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Pregnancy, puerperium and perinatal conditions Placenta praevia	0.00% 0/68 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	6.7% 3/45 • Number of events 3 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Pregnancy, puerperium and perinatal conditions Threatened labour	1.5% 1/68 • Number of events 1 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	8.9% 4/45 • Number of events 4 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Respiratory, thoracic and mediastinal disorders Cough	7.4% 5/68 • Number of events 5 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/45 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/88 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	3.6% 2/55 • Number of events 2 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Hepatobiliary disorders Hyperbilirubinaemia neonatal	0.00% 0/68 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/45 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	5.7% 5/88 • Number of events 5 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/55 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	0.00% 0/68 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	0.00% 0/45 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	4.5% 4/88 • Number of events 6 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)	5.5% 3/55 • Number of events 3 • From approximately 10 weeks after ET in base study P05690 (NCT00702845) up to 12 weeks after birth in current follow-up study (up to approximately 9 months)

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
Publication restrictions are in place

Restriction type: OTHER