{"eventGroups":[{"description":"SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.","id":"EG000","otherNumAffected":36,"otherNumAtRisk":129,"seriousNumAffected":1,"seriousNumAtRisk":129,"title":"SJ-0021"},{"description":"Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.","id":"EG001","otherNumAffected":40,"otherNumAtRisk":132,"seriousNumAffected":1,"seriousNumAtRisk":132,"title":"u-hFSH"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":129,"numEvents":7},{"groupId":"EG001","numAffected":14,"numAtRisk":132,"numEvents":17}],"term":"Abdominal pain lower"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":129,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":132,"numEvents":7}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":129,"numEvents":4},{"groupId":"EG001","numAffected":7,"numAtRisk":132,"numEvents":7}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":129,"numEvents":10},{"groupId":"EG001","numAffected":11,"numAtRisk":132,"numEvents":11}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":129,"numEvents":6},{"groupId":"EG001","numAffected":8,"numAtRisk":132,"numEvents":9}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":129,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":132,"numEvents":4}],"term":"Ovarian hyperstimulation syndrome"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":129,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":132,"numEvents":1}],"term":"Ovarian hyperstimulation syndrome"}],"timeFrame":"AEs were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final post-treatment examination, on Day 35-42 of the post-treatment assessment period."}