{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}],"title":"Complete clinical response"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Partial clinical response"},{"measurements":[{"groupId":"OG000","value":"6"}],"title":"No response or clinical progression"},{"measurements":[{"groupId":"OG000","value":"3"}],"title":"Death before day 28"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"}],"units":"Participants"}],"description":"Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by \\> 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.","groups":[{"description":"Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Treated Patients"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"at 28 days after starting treatment with the study product","title":"Functional Recovery","type":"PRIMARY","unitOfMeasure":"Participants"}