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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004967-30 | EudraCT Number | ||
| 38829 | Other Identifier | Organon | |
| MK-8962-008 | Other Identifier | Merck |
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The objective of this trial is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring. In addition, a primary efficacy variable, live birth rate, was evaluated.
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of women who were treated with corifollitropin alfa and became pregnant after fresh embryo transfer during the base study P05714 (NCT00696878). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women/Expectant Mothers - Corifollitropin Alfa 150 µg | In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh embryo transfer in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alfa | Biological | Subcutaneous (SC) administration of corifollitropin alfa at a dose of 150 μg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) | The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants. | Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) |
| Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) |
| Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) |
| Number of Live Born Infants Experiencing AEs | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with an ongoing pregnancy at least 10 weeks after fresh embryo transfer in base study P05714 (NCT00696878) were enrolled in this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22587997 | Derived | Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15. |
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To complete base study P05714 (NCT00696878), a participant must have embryo transfer in the 3rd Controlled Ovarian Stimulation (COS) cycle (Treatment Cycle 3). For this follow-up trial P05715, study completion for participant (expectant mother) or live born infant was defined as completion of infant follow-up visit at 4-12 weeks after delivery.
Of 272 participants with ongoing pregnancy at 10 weeks after fresh embryo transfer (ET) in base study P05714 (NCT00696878), 268 enrolled in this follow-up study P05715. A participant could enter follow-up study without meeting formal definition for "Completion" of base study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Women/Expectant Mothers - Corifollitropin Alfa 150 µg | In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of Gonadotropin Releasing Hormone (GnRH) antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. |
| FG001 | Fetuses Present at 10 Weeks After Fresh ET in Base Study | This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study (NCT00696878) |
| |||||||||||||
| Follow-up Study: Expectant Mothers |
| |||||||||||||
| Follow-up Study: Fetuses/Infants |
|
Individuals who participated in base study P05714 (NCT00696878) and received at least one dose of corifollitropin alfa, who had an ongoing pregnancy confirmed by ultrasound at least 10 weeks after fresh ET in base study P05714 and were able and willing to give written informed consent to be enrolled in the follow-up study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Expectant Mothers - Corifollitropin Alfa 150 µg | In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. |
| 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 Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate) | The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants. | Participants administered corifollitropin alfa in base study P05714 (NCT00696878) | Posted | Number | percentage of participants | Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878) |
|
From approximately 10 weeks after fresh ET in base study P05714 (NCT00696878) up to 12 weeks after birth in current follow-up study (Up to approximately 9 months).
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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 | Expectant Mothers - Corifollitropin Alfa 150 µg | In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | 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 |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| GnRH antagonist | Biological | SC administration of a GnRH antagonist at a dose of 0.25 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered. |
|
| (rec)hCG | Biological | SC administration of (rec)hCG at a dose of 5,000-10,000 IU/250 µg in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered. |
|
| FSH | Biological | SC administration of FSH at a dose not to exceed 225 IU/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered. |
|
| Progesterone | Drug | Vaginal administration of progesterone at a dose of at least 600 mg/day in base study P05714 (NCT00696878). In this follow-up study P05715, no study medications were administered. |
|
| Up to 12 weeks after birth |
| Number of Live Born Infants Experiencing SAEs | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Up to 12 weeks after birth |
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
In base study P05714 (NCT00696878), up to 3 COS cycles were performed, each including the following treatments: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of (rec)hCG (5,000-10,000 IU/250 µg). Daily dosing with FSH (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone was administered for luteal phase support. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur. Participants with confirmed pregnancy at least 10 weeks after fresh ET in the base study were eligible for this follow-up study. In this follow-up study P05715, no study drugs were administered.
|
|
| Primary | Number of Expectant Mothers Experiencing Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | Posted | Number | participants | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) |
|
|
|
| Primary | Number of Expectant Mothers Experiencing Serious AEs (SAEs) | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | Posted | Number | participants | From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months) |
|
|
|
| Primary | Number of Live Born Infants Experiencing AEs | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | Posted | Number | participants | Up to 12 weeks after birth |
|
|
|
| Primary | Number of Live Born Infants Experiencing SAEs | An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study. | Posted | Number | participants | Up to 12 weeks after birth |
|
|
|
| 145 |
| 268 |
| 0 |
| 268 |
| EG001 | Fetuses Present at 10 Weeks After Fresh ET in Base Study | This group includes fetuses associated with expectant mothers who were administered corifollitropin alfa in base study P05714 (NCT00696878) who were enrolled in this follow-up study P05715. The fetuses were present at 10 weeks after fresh ET in base study P05714 and/or at enrollment of the expectant mother in this follow-up study P05715. | 84 | 315 | 0 | 315 |
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation in newborn | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradycardia foetal | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bradycardia neonatal | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardio-respiratory arrest neonatal | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Foetal heart rate disorder | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ventricular hypokinesia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anal atresia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anomaly of external ear congenital | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cleft palate | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital cytomegalovirus infection | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital diaphragmatic hernia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital hand malformation | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital hydrocephalus | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital infection | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital nose malformation | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital pulmonary artery anomaly | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital pulmonary hypertension | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital tongue anomaly | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Congenital torticollis | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cystic lymphangioma | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Duodenal atresia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysmorphism | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Factor IX deficiency | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Factor VIII deficiency | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oculoauriculovertebral dysplasia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary malformation | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary sequestration | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal dysplasia | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skull malformation | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Solitary kidney | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Strabismus congenital | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Syndactyly | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Trisomy 18 | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| VACTERL syndrome | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Retinopathy of prematurity | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholestasis of pregnancy | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Milk allergy | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Endometritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Neonatal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Uterine infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Perineal laceration | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Amniotic fluid volume decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Foetal heart rate abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Foetal heart rate increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Gestational diabetes | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Delayed fontanelle closure | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral haemorrhage neonatal | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Delayed delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal acidosis | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal growth retardation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal malposition | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
|
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| High risk pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Multiple pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Pregnancy induced hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Previous caesarean section | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Transverse presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Umbilical cord prolapse | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Uterine contractions abnormal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 | Systematic Assessment |
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| Mental disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Perineal fistula | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
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| Vaginal laceration | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Immature respiratory system | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Infantile apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Neonatal aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Cafe au lait spots | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
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| Caesarean section | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
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| Selective abortion | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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Publications must be based on data validated and released by the Sponsor. Any scientific paper, presentation, or other communication concerning the study must first be submitted to the Sponsor, at least 6 weeks prior to estimated publication or presentation, for written consent. Sponsor has the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the Investigator in the discussion of the data in such communications.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |