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The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa 150 μg | Experimental | Participants in Base Study P06029 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. No medication or investigational product was administered in Follow-Up Study P06031. |
|
| recFSH 300 IU | Active Comparator | Participants in the reference group in Base Study P06029 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. No medication or investigational product was administered in Follow-Up Study P06031. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alfa | Biological | Single injection of 150 μg corifollitropin alfa administered under protocol P06029 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | 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. | 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) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27090863 | Result | Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study P06029 (NCT01144416) |
| |||||||||||||
| Women/Expectant Mother Follow Up |
| |||||||||||||
| Live-Born Infant Follow Up |
|
All Subjects Evaluable, restricted to subjects with ET
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | 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). | Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 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) |
|
From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Corifollitropin Alfa 150 μg Participants With ET | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia foetal | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571802 | follitropin beta |
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| recFSH (follitropin beta) | Biological | Daily recFSH 300 IU administered under protocol P06029. |
|
|
| Participants With Embryo Transfer (ET) |
|
| Participants With an Ongoing Pregnancy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | 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. |
| OG001 | 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. |
|
|
|
| Secondary | Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | 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. | FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 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) |
|
|
|
|
| 4 |
| 151 |
| 64 |
| 151 |
| EG001 | recFSH 300 IU Participants With ET | 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. | 3 | 147 | 45 | 147 |
| EG002 | Corifollitropin Alfa 150 μg 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. | 34 | 52 | 26 | 52 |
| EG003 | recFSH 300 IU 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. | 29 | 50 | 19 | 50 |
| EG004 | Corifollitropin Alfa 150 μg Follow-up Fetuses/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. | 15 | 61 | 18 | 61 |
| EG005 | recFSH 300 IU Follow-up Fetuses/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 | 17 | 56 | 21 | 56 |
| Congenital coronary artery malformation | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Congenital hydronephrosis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Congenital torticollis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Congenital umbilical hernia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dacryostenosis congenital | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Duodenal atresia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Single umbilical artery | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Skull malformation | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Foetal heart rate abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Complication of delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Pregnancy with advanced maternal age | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Previous caesarean section | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
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| Transverse presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Neonatal respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Myomectomy | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Cardiac arrest neonatal | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anal atresia | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Congenital cardiovascular anomaly | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Congenital lacrimal passage anomaly | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Congenital ovarian anomaly | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Temperature regulation disorder | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection neonatal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Bradycardia foetal | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Birth mark | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Amniotic cavity infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Funisitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Foetal heart rate decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Placenta praevia haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Congenital pyelocaliectasis | Congenital, familial and genetic disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anaphylactoid syndrome of pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Selective abortion | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
|
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Uterine leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting neonatal | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Perineal injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Afterbirth pain | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Labour pain | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
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.