Trial Outcomes & Findings for Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) (NCT NCT01146418)
NCT ID: NCT01146418
Last Updated: 2024-06-20
Results Overview
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Results posted on
2024-06-20
Participant Flow
Period 1 consists of participants from Base Study P06029 (NCT01144416) randomized to treatment groups corifollitropin alfa or recombinant follicle stimulating hormone (recFSH). Period 2 consists of participants from base study enrolled in Follow-Up Study P06031. Period 3 consists of infants born to expectant mothers in Follow-Up Study P06031.
Participant milestones
| Measure |
Corifollitropin Alfa 150 μg Women/Expectant Mothers
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Women/Expectant Mothers
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Corifollitropin Alfa 150 μg Live-Born Infants
Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
|
recFSH 300 IU Live-Born Infants
Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
|
|---|---|---|---|---|
|
Base Study P06029 (NCT01144416)
STARTED
|
694
|
696
|
0
|
0
|
|
Base Study P06029 (NCT01144416)
COMPLETED
|
632
|
647
|
0
|
0
|
|
Base Study P06029 (NCT01144416)
NOT COMPLETED
|
62
|
49
|
0
|
0
|
|
Women/Expectant Mother Follow Up
STARTED
|
157
|
150
|
0
|
0
|
|
Women/Expectant Mother Follow Up
Participants With Embryo Transfer (ET)
|
151
|
147
|
0
|
0
|
|
Women/Expectant Mother Follow Up
Participants With an Ongoing Pregnancy
|
52
|
50
|
0
|
0
|
|
Women/Expectant Mother Follow Up
COMPLETED
|
113
|
110
|
0
|
0
|
|
Women/Expectant Mother Follow Up
NOT COMPLETED
|
44
|
40
|
0
|
0
|
|
Live-Born Infant Follow Up
STARTED
|
0
|
0
|
61
|
56
|
|
Live-Born Infant Follow Up
COMPLETED
|
0
|
0
|
55
|
51
|
|
Live-Born Infant Follow Up
NOT COMPLETED
|
0
|
0
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Baseline characteristics by cohort
| Measure |
Corifollitropin Alfa 150 μg Women/Expectant Mothers
n=151 Participants
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Women/Expectant Mothers
n=147 Participants
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 Years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
38.3 Years
STANDARD_DEVIATION 2.2 • n=107 Participants
|
38.4 Years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
298 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: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)Population: Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Outcome measures
| Measure |
Corifollitropin Alfa 150 μg Women/Expectant Mothers
n=694 Participants
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Women/Expectant Mothers
n=696 Participants
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
|---|---|---|
|
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
|
31.1 Percentage of Participants
Interval 27.7 to 34.7
|
33.0 Percentage of Participants
Interval 29.6 to 36.7
|
SECONDARY outcome
Timeframe: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)Population: FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Outcome measures
| Measure |
Corifollitropin Alfa 150 μg Women/Expectant Mothers
n=694 Participants
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Women/Expectant Mothers
n=696 Participants
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
|---|---|---|
|
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
|
28.2 Percentage of Participants
Interval 24.9 to 31.8
|
29.5 Percentage of Participants
Interval 26.1 to 33.0
|
Adverse Events
Corifollitropin Alfa 150 μg Participants With ET
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
recFSH 300 IU Participants With ET
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Corifollitropin Alfa 150 μg Expectant Mothers
Serious events: 34 serious events
Other events: 26 other events
Deaths: 0 deaths
recFSH 300 IU Expectant Mothers
Serious events: 29 serious events
Other events: 19 other events
Deaths: 0 deaths
Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants
Serious events: 15 serious events
Other events: 18 other events
Deaths: 0 deaths
recFSH 300 IU Follow-up Fetuses/Infants
Serious events: 17 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Corifollitropin Alfa 150 μg Participants With ET
n=151 participants at risk
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Participants With ET
n=147 participants at risk
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Corifollitropin Alfa 150 μg Expectant Mothers
n=52 participants at risk
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Expectant Mothers
n=50 participants at risk
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants
n=61 participants at risk
Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
|
recFSH 300 IU Follow-up Fetuses/Infants
n=56 participants at risk
Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
|
|---|---|---|---|---|---|---|
|
Investigations
Foetal heart rate abnormal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.66%
1/151 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labour
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
9.6%
5/52 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.0%
3/50 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
10.0%
5/50 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Complication of delivery
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction of labour
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal macrosomia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal malpresentation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.68%
1/147 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with advanced maternal age
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
9.8%
6/61 • Number of events 6 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
12.5%
7/56 • Number of events 7 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
4.0%
2/50 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
4.0%
2/50 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Previous caesarean section
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
13.5%
7/52 • Number of events 7 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged pregnancy
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Transverse presentation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Twin pregnancy
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory arrest
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.4%
3/56 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Surgical and medical procedures
Caesarean section
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.7%
4/52 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Cardiac disorders
Cardiac arrest neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Anal atresia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.6%
2/56 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital cardiovascular anomaly
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.6%
2/56 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital lacrimal passage anomaly
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital ovarian anomaly
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Haemangioma congenital
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.6%
2/56 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Urinary tract infection neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.6%
2/56 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Cardiac disorders
Bradycardia foetal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Funisitis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Investigations
Foetal heart rate decreased
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord abnormality
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia haemorrhage
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital pyelocaliectasis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Anaphylactoid syndrome of pregnancy
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.68%
1/147 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.68%
1/147 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Surgical and medical procedures
Selective abortion
|
0.66%
1/151 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
0.66%
1/151 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.66%
1/151 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyosarcoma
|
0.66%
1/151 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Cardiac disorders
Tachycardia foetal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital hydronephrosis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.6%
2/56 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital torticollis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Congenital umbilical hernia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
4.9%
3/61 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.3%
2/61 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Duodenal atresia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Fallot's tetralogy
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Pulmonary artery stenosis congenital
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Single umbilical artery
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Skull malformation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.6%
1/61 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
Other adverse events
| Measure |
Corifollitropin Alfa 150 μg Participants With ET
n=151 participants at risk
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Participants With ET
n=147 participants at risk
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Corifollitropin Alfa 150 μg Expectant Mothers
n=52 participants at risk
Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
recFSH 300 IU Expectant Mothers
n=50 participants at risk
Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
|
Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants
n=61 participants at risk
Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
|
recFSH 300 IU Follow-up Fetuses/Infants
n=56 participants at risk
Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
9.6%
5/52 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Nervous system disorders
Headache
|
5.3%
8/151 • Number of events 11 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.4%
5/147 • Number of events 6 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
12.0%
6/50 • Number of events 6 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.2%
5/61 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
17.9%
10/56 • Number of events 10 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
9.3%
14/151 • Number of events 17 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.5%
11/147 • Number of events 15 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.9%
1/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.0%
3/50 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.6%
4/61 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.4%
3/56 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Gastrointestinal disorders
Vomiting neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.6%
4/61 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.4%
3/56 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
11.5%
7/61 • Number of events 7 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.1%
4/56 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
4.9%
3/61 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.9%
5/56 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.6%
4/61 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
1.8%
1/56 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.0%
3/50 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.7%
4/52 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.0%
3/50 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
9.6%
5/52 • Number of events 5 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Afterbirth pain
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.7%
4/52 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
4.0%
2/50 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
7.7%
4/52 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
6.0%
3/50 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Labour pain
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
2.0%
1/50 • Number of events 1 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
3.8%
2/52 • Number of events 2 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
8.0%
4/50 • Number of events 4 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/151 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/147 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.8%
3/52 • Number of events 3 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
6.6%
10/151 • Number of events 10 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
5.4%
8/147 • Number of events 8 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
24.5%
37/151 • Number of events 38 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
15.0%
22/147 • Number of events 24 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
8.6%
13/151 • Number of events 18 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
10.2%
15/147 • Number of events 17 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/52 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/50 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/61 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
0.00%
0/56 • From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
|
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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER