Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
NCT ID:
NCT01146418
Description:
None
Frequency Threshold:
5
Time Frame:
From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years)
Study:
NCT01146418
Study Brief:
Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 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. | None | None | 4 | 151 | 64 | 151 | View |
| 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. | None | None | 3 | 147 | 45 | 147 | View |
| 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. | None | None | 34 | 52 | 26 | 52 | View |
| 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. | None | None | 29 | 50 | 19 | 50 | View |
| 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. | None | None | 15 | 61 | 18 | 61 | View |
| 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 | None | None | 17 | 56 | 21 | 56 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia foetal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| Congenital coronary artery malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital hydronephrosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital torticollis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital umbilical hernia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Dacryostenosis congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Duodenal atresia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Fallot's tetralogy | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Phimosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Pulmonary artery stenosis congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Single umbilical artery | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Skull malformation | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Trisomy 21 | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Foetal heart rate abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.0 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Arrested labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Breech presentation | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Cephalo-pelvic disproportion | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Complication of delivery | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Failed induction of labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Foetal macrosomia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Foetal malpresentation | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Gestational hypertension | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Jaundice neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Placenta praevia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Pre-eclampsia | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Pregnancy with advanced maternal age | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Premature baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Premature labour | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Premature rupture of membranes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Premature separation of placenta | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Previous caesarean section | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Prolonged pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Transverse presentation | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Twin pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Neonatal respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| Neonatal respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| Caesarean section | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 17.0 | View |
| Myomectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 17.0 | View |
| Cardiac arrest neonatal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| Anal atresia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Ankyloglossia congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Atrial septal defect | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital cardiovascular anomaly | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital lacrimal passage anomaly | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital naevus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Congenital ovarian anomaly | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Haemangioma congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Intraventricular haemorrhage neonatal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Hypospadias | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Patent ductus arteriosus | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Temperature regulation disorder | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Hyperbilirubinaemia neonatal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 17.0 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Urinary tract infection neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Bradycardia foetal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| Birth mark | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Amniotic cavity infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Funisitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Foetal heart rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 17.0 | View |
| Umbilical cord abnormality | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Postpartum haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Placenta praevia haemorrhage | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Congenital pyelocaliectasis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.0 | View |
| Anaphylactoid syndrome of pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Foetal growth restriction | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Gestational diabetes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Abortion missed | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Cervical incompetence | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Selective abortion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 17.0 | View |
| Benign hydatidiform mole | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
| Uterine leiomyosarcoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Jaundice neonatal | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Vomiting neonatal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Sepsis neonatal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.0 | View |
| Premature baby | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Hyperbilirubinaemia neonatal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 17.0 | View |
| Neonatal respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 17.0 | View |
| Perineal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| Procedural nausea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| Afterbirth pain | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.0 | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.0 | View |
| Abortion missed | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Haemorrhage in pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Vomiting in pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Gestational diabetes | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |
| Labour pain | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | View |