{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}],"title":"Alanine Aminotransferase:High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"title":"Albumin: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"3"}]}],"title":"Alkaline Phosphatase: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}],"title":"Aspartate Aminotransferase: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Bilirubin: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"1"}]}],"title":"Calcium: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Calcium: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Creatine Kinase: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Creatinine: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"1"}]}],"title":"Glucose: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Magnesium: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Magnesium: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"2"}]}],"title":"Phosphate: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}],"title":"Potassium: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"title":"Potassium: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"0"}]}],"title":"Sodium: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Sodium: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"4"}]}],"title":"Hemoglobin: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Hemoglobin: High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}],"title":"Leukocytes: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"5"}]}],"title":"Lymphocytes: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Neutrophils: Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"}]}],"title":"Platelet; Low"}],"denoms":[{"counts":[{"groupId":"OG000","value":"800"},{"groupId":"OG001","value":"399"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"description":"Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.","groups":[{"description":"In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).","id":"OG000","title":"Enzalutamide"},{"description":"In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).","id":"OG001","title":"Placebo: DB Phase"},{"description":"Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).","id":"OG002","title":"Placebo (DB) /Enzalutamide 160 mg (OLE) Phase"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population was defined as all randomized participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)","title":"Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}