Trial Outcomes & Findings for Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783) (NCT NCT00702520)
NCT ID: NCT00702520
Last Updated: 2024-09-05
Results Overview
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
Up to 1 Year
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
Infants From Mothers Administered Corifollitropin Alpha 100 ug
Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
|
Infants From Mothers Administered Cori. Alpha 150 ug
Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
|
|---|---|---|---|---|
|
Base Study P05788 - Assigned Treatment
STARTED
|
25
|
25
|
0
|
0
|
|
Base Study P05788 - Assigned Treatment
Treated With Corifollitropin Alpha
|
25
|
24
|
0
|
0
|
|
Base Study P05788 - Assigned Treatment
Treated With hCG and Had Oocyte Pick-up
|
25
|
24
|
0
|
0
|
|
Base Study P05788 - Assigned Treatment
COMPLETED
|
25
|
24
|
0
|
0
|
|
Base Study P05788 - Assigned Treatment
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Base Study P05788 - Embryo Transfer
STARTED
|
25
|
24
|
0
|
0
|
|
Base Study P05788 - Embryo Transfer
Embryo Transfer
|
22
|
18
|
0
|
0
|
|
Base Study P05788 - Embryo Transfer
COMPLETED
|
22
|
18
|
0
|
0
|
|
Base Study P05788 - Embryo Transfer
NOT COMPLETED
|
3
|
6
|
0
|
0
|
|
Base Study P05788 - Follow-Up
STARTED
|
22
|
18
|
0
|
0
|
|
Base Study P05788 - Follow-Up
Ongoing Pregnancy at 10 Weeks
|
7
|
8
|
0
|
0
|
|
Base Study P05788 - Follow-Up
COMPLETED
|
7
|
8
|
0
|
0
|
|
Base Study P05788 - Follow-Up
NOT COMPLETED
|
15
|
10
|
0
|
0
|
|
Follow-up Study P05783
STARTED
|
7
|
8
|
8
|
11
|
|
Follow-up Study P05783
COMPLETED
|
7
|
8
|
8
|
11
|
|
Follow-up Study P05783
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
Infants From Mothers Administered Corifollitropin Alpha 100 ug
Infants born to mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
|
Infants From Mothers Administered Cori. Alpha 150 ug
Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520). No study medications were administered in the follow-up P05783 study.
|
|---|---|---|---|---|
|
Base Study P05788 - Assigned Treatment
Spontaneous pregnancy
|
0
|
1
|
0
|
0
|
|
Base Study P05788 - Embryo Transfer
No embryo transfer
|
3
|
6
|
0
|
0
|
|
Base Study P05788 - Follow-Up
No ongoing pregnancy at 10 weeks
|
15
|
10
|
0
|
0
|
Baseline Characteristics
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Baseline characteristics by cohort
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=7 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=8 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.1 Years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
31.3 Years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
30.7 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearPopulation: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Outcome measures
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=7 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=8 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|
|
Number of Expectant Mothers Experiencing Adverse Events (AEs)
|
7 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearPopulation: Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=7 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=8 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|
|
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearPopulation: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Outcome measures
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=8 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=11 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|
|
Number of Infants Experiencing AEs
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to 1 YearPopulation: Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=8 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=11 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|
|
Number of Infants Experiencing SAEs
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Birth of a one or more live babies (Up to 1 year)Population: Participants treated with Corifollitropin alpha in the base study (P05788, 38833).
The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).
Outcome measures
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=25 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the follow-up P05783 study.
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=24 Participants
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|
|
Take-Home Baby Rate
|
28.0 Percentage of participants
|
33.3 Percentage of participants
|
Adverse Events
Expectant Mothers Administered Corifollitropin Alpha 100 ug
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Expectant Mothers Administered Corifollitropin Alpha 150 ug
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=7 participants at risk
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=8 participants at risk
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug
n=8 participants at risk
Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
|
Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug
n=11 participants at risk
Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Accessory auricle
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Congenital choroid plexus cyst
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Congenital labia pudendi adhesions
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Congenital laryngeal stridor
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Pilonidal cyst congenital
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Pulmonary valve stenosis congenital
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Scaphocephaly
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Skull malformation
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
18.2%
2/11 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Hepatobiliary disorders
Cholestasis of pregnancy
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Investigations
Blood pressure decreased
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
27.3%
3/11 • Number of events 3 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Intercostal retraction
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal anoxia
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
Other adverse events
| Measure |
Expectant Mothers Administered Corifollitropin Alpha 100 ug
n=7 participants at risk
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520).
|
Expectant Mothers Administered Corifollitropin Alpha 150 ug
n=8 participants at risk
In the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study.
|
Fetuses/Infants From Mothers Administered Cori. Alpha 100 ug
n=8 participants at risk
Fetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
|
Fetuses/Infants From Mothers Administered Cori. Alpha 150 ug
n=11 participants at risk
Fetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Congenital, familial and genetic disorders
Craniotabes
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Gastrointestinal disorders
Gastric disorder
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
37.5%
3/8 • Number of events 3 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 2 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
General disorders
Fever neonatal
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
General disorders
Suprapubic pain
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
18.2%
2/11 • Number of events 2 • Up to 1 year
|
|
Infections and infestations
Candidiasis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
27.3%
3/11 • Number of events 4 • Up to 1 year
|
|
Infections and infestations
Ear infection
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
36.4%
4/11 • Number of events 4 • Up to 1 year
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
36.4%
4/11 • Number of events 5 • Up to 1 year
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
18.2%
2/11 • Number of events 2 • Up to 1 year
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
37.5%
3/8 • Number of events 3 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Investigations
Streptococcal identification test positive
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Antepartum haemorrhage
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Intrapartum haemorrhage
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Meconium in amniotic fluid
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Perineal laceration
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia haemorrhage
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
42.9%
3/7 • Number of events 3 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
9.1%
1/11 • Number of events 1 • Up to 1 year
|
|
Surgical and medical procedures
Cervix cerclage procedure
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
14.3%
1/7 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
|
Vascular disorders
Varicose vein
|
0.00%
0/7 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/11 • Up to 1 year
|
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 the 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