{"eventGroups":[{"description":"Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \\>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).","id":"EG000","otherNumAffected":32,"otherNumAtRisk":54,"seriousNumAffected":1,"seriousNumAtRisk":54,"title":"MSJ-0011"},{"description":"Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \\>=18 mm; not more than 3 follicles each with a mean diameter of \\>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.","id":"EG001","otherNumAffected":11,"otherNumAtRisk":27,"seriousNumAffected":0,"seriousNumAtRisk":27,"title":"u-hCG"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":54},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Injection site bruising"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":54},{"groupId":"EG001","numAffected":2,"numAtRisk":27}],"term":"Injection site erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":27}],"term":"Injection site pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Injection site swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Acute tonsillitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":54},{"groupId":"EG001","numAffected":1,"numAtRisk":27}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Haemorrhage in pregnancy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Dysmenorrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Genital haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Haemorrhagic ovarian cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":54},{"groupId":"EG001","numAffected":3,"numAtRisk":27}],"term":"Ovarian cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Ovarian enlargement"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":54},{"groupId":"EG001","numAffected":4,"numAtRisk":27}],"term":"Ovarian hyperstimulation syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Uterine haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Drug eruption"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Eczema"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":54},{"groupId":"EG001","numAffected":0,"numAtRisk":27}],"term":"Ovarian hyperstimulation syndrome"}],"timeFrame":"From signing of the informed consent document until Day 28-31 (for subjects who had a negative serum β-hCG pregnancy test on Day 15-20), or up to the Day 35-42 post hCG treatment (for subjects who have a positive serum β-hCG pregnancy test on Day 15-20)."}