Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004772-36 | EudraCT Number | ||
| 38821 | Other Identifier | Organon | |
| MK-8962-005 | Other Identifier | Merck |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this trial was to evaluate whether Corifollitropin Alfa 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) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mothers Corifollitropin Alfa 150 µg | Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| |
| Mothers recFSH 200 IU | Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin Alfa 150 μg | Drug | In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg (0.5 mL) Corifollitropin Alfa was administered in the abdominal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. | Up to one day following delivery (up to 1 year) |
| Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Up to one day following delivery (up to 1 year) |
| Number of Infants Born in Current Follow Up Trial Experiencing AEs | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. | Up to 12 weeks following delivery (up to 1 year) |
| Number of Infants in Current Follow Up Trial Experiencing SAEs | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Up to 12 weeks following delivery (up to 1 year) |
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. |
Not provided
Not provided
Inclusion Criteria:
Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
Exclusion Criteria:
Not provided
Not provided
Women with an ongoing pregnancy at least 10 weeks after ET in Base Trial P05787 (NCT00696800) were enrolled in this trial.
| 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. | |
| 22459628 | Derived |
Not provided
Not provided
Period one consists of mothers from the Base Trial P05787 (NCT00696800), randomized to treatment groups Corifollitropin Alfa (Org 36286) or recombinant Follicle Stimulating Hormone (recFSH). Period two consists of mothers (N = 541) who enrolled in trial P05712. Period three consists of miscarried/stillborn fetuses and infants born in trial P05712.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mothers Corifollitropin Alfa 150 µg | Participants from the Base Trial P05787 (NCT00696800) who received a subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of human Chorion Gonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of oocyte pick-up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Mothers Base Trial P05787 (NCT00696800) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| 200 IU RecFSH/Follitropin beta (Days 1 to 7) | Biological | In the Base Trial P05787, daily SC injections with 200 IU fixed dose recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. |
|
|
| Placebo for Corifollitropin Alfa | Drug | In the Base Trial P05787, on the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection from a pre-filled syringe containing an identical solution when compared to Corifollitropin Alfa was administered in the abdominal wall. |
|
| Placebo for RecFSH/Follitropin beta | Drug | In the Base Trial P05787, daily SC injections of an identical ready-for-use solution, but without the active ingredient, supplied in cartridges for SC injection with the Follistim Pen, were started on Stimulation Day 1 and continued up to and including Stimulation Day 7. |
|
| 200 IU RecFSH/Follitropin beta (Days 8 to hCG) | Biological | In the Base Trial P05787, from Stimulation Day 8 onwards a daily SC dose of 200 IU recFSH was administered up to and including the Day of hCG. |
|
| Ganirelix | Drug | In the Base Trial P05787, on Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG. |
|
| hCG | Biological | In the Base Trial P05787, when 3 follicles >= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP |
|
| Progesterone | Biological | In the Base Trial P05787, on the day of OPU, luteal phase support was started by administering micronized progesterone of at least 600 mg/day vaginally, or at least 50 mg/day intramuscular (IM), which continued for at least 6 weeks, or up to menses. |
|
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial. |
| At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year) |
| Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. | The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer. | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year) |
| Boostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28. |
| FG001 | Mothers recFSH 200 IU | Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| FG002 | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800) |
| FG003 | Fetuses/Infants recFSH 200 IU | Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800) |
| Treated |
|
| Embryo Transfer |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Mothers Follow Up Trial P05712 |
|
|
| Fetuses/Infants Follow Up Trial P05712 |
|
|
Eligible mothers from the Base Trial P05787 (NCT00696800) who enrolled in Follow Up Trial P05712
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mothers Corifollitropin Alfa 150 µg | Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| BG001 | Mothers recFSH 200 IU | Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. | Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Posted | Number | Participants | Up to one day following delivery (up to 1 year) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Posted | Number | Participants | Up to one day following delivery (up to 1 year) |
| |||||||||||||||||||||||||||||||
| Primary | Number of Infants Born in Current Follow Up Trial Experiencing AEs | An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product. | Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure. | Posted | Number | Participants | Up to 12 weeks following delivery (up to 1 year) |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Infants in Current Follow Up Trial Experiencing SAEs | A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure. | Posted | Number | Participants | Up to 12 weeks following delivery (up to 1 year) |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. | The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial. | Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Posted | Number | Percentage of Participants | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year) |
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. | The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer. | Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure. | Posted | Number | Percentage of Participants | At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year) |
|
Mothers: up to one day after delivery; Fetuses and Infants: up to 12 weeks after birth
All study treatments were considered to be administered to the mother.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mothers Corifollitropin Alfa 150 µg | Participants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. | 129 | 274 | 112 | 274 | ||
| EG001 | Mothers recFSH 200 IU | Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. | 117 | 267 | 118 | 267 | ||
| EG002 | Fetuses/Infants Corifollitropin Alfa 150 µg | Fetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800) | 106 | 352 | 37 | 352 | ||
| EG003 | Fetuses/Infants recFSH 200 IU | Fetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800) | 94 | 326 | 41 | 326 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Placental transfusion syndrome | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia neonatal | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bradycardia foetal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bradycardia neonatal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac hypertrophy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest neonatal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary valve stenosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia foetal | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abnormal palmar/planta creases | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Accessory auricle | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ankyloglossia congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrioventricular septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bat ear | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervical rib | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chondrodystrophy | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cleft lip | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cleft palate | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cleft uvula | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Clinodactyly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital anaemia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital aortic anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital aortic stenosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital aortic valve stenosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital central nervous system anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital cerebral cyst | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital choroid plexus cyst | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital coronary artery malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital cyst | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital eyelid malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital foot malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital hand malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital hearing disorder | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital hip deformity | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital hydrocephalus | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital inguinal hernia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital labia pudendi adhesions | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital mitral valve stenosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital nose malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital optic nerve anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital ovarian anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital pyelocaliectasis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital spinal cord anomaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital torticollis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital tracheomalacia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Craniotabes | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cryptorchism | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dacryostenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Duodenal atresia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Exomphalos | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eyelid ptosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertelorism of orbit | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Immunodeficiency congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pilonidal cyst congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Plagiocephaly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary valve stenosis congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhesus haemolytic disease of newborn | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Single umbilical artery | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skull malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Strabismus congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Supernumerary nipple | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syndactyly | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Secondary hypogonadism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lacrimal cyst | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome neonatal | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fever neonatal | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal multi-organ faillure | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sudden infant death syndrome | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal cholestasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Meningitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Acoustic stimulation tests abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Amniotic fluid volume decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood glucose fluctuation | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Body temperature decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Cytomegalovirus antibody positive | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal heart rate abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal heart rate decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoglobin Barts present | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Cow's milk intolerance | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatty acid deficiency | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gestational diabetes | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Loctose intolerance | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Head deformity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotonia neonatal | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Positional plagiocephaly | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral haemorrhage neonatal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Convulsion neonatal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Encephalopathy neonatal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Superior sagittal sinus thrombosis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Caput succedaneum | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Discordant twin | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Face presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal growth retardation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal malposition | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Hydrops foetalis | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Intrapartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Meconium stain | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Multiple pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Placenta accreta | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Pregnancy induced hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Previous caesarean section | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Transverse presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Umbilical cord around neck | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Umbilical cord prolapse | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Agitation neonatal | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure neonatal | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervix oedema | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chordee | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian enlargement | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ovarian torsion | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Shortened cervix | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine atony | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Infantile apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory disorder neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Caesarean section | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Evacuation of retained products of conception | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Labour induction | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Selective abortion | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension neonatal | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoperfusion | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neonatal hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gestational diabetes | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Antepartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA 12.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
Any scientific paper, presentation, or other communication concerning the clinical trial will first be presented to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent. The Sponsor shall have the right to make its consent conditional upon proper representation of the interpretation of both the Sponsor and the investigator(s) in the discussion of the data in such communications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571802 | follitropin beta |
| C061018 | ganirelix |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
Not provided
Not provided
| Male |
|
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
|
|
|
|
| Mothers recFSH 200 IU |
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
|
|
| OG001 |
| Mothers recFSH 200 IU |
Participants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles >= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. |
|
|