{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.8"},{"groupId":"OG001","value":"8.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"description":"VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level \\>34 micromoles per liter (μmol/L) (\\>2.0 milligrams per deciliter \\[mg/dL\\]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain \\>2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.","groups":[{"description":"Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\\^2 (for a total cycle dose of 1.5 mg/m\\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).","id":"OG000","title":"Inotuzumab Ozogamicin"},{"description":"Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.","id":"OG001","title":"Defined Investigator's Choice of Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Participants in the Safety population with post-study HSCT. A site visit in July 2017 (after clinical database lock), confirmed a fourth case of VOD/SOS occurred in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after the last dose).This was not entered on the CRF and therefore, is not included below.","reportingStatus":"POSTED","timeFrame":"Up to 2 years from randomization","title":"Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}