{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"66"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Discontinuation due to AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"description":"AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.","groups":[{"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":"OG000","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":"OG001","title":"u-hFSH"}],"paramType":"NUMBER","populationDescription":"Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.","reportingStatus":"POSTED","timeFrame":"Pretrial observation period to post-treatment assessment period (Days 35-42)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation","type":"SECONDARY","unitOfMeasure":"participants"}