{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.1"},{"groupId":"OG001","value":"23.4"},{"groupId":"OG002","value":"27.9"},{"groupId":"OG003","value":"32.7"},{"groupId":"OG004","value":"40.0"},{"groupId":"OG005","value":"37.1"}]}],"title":"Percentage of Patients w Grade 1 Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24.8"},{"groupId":"OG001","value":"34.4"},{"groupId":"OG002","value":"34.6"},{"groupId":"OG003","value":"29.8"},{"groupId":"OG004","value":"45.0"},{"groupId":"OG005","value":"33.9"}]}],"title":"Percentage of Patients w Grade 2 Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30.7"},{"groupId":"OG001","value":"28.1"},{"groupId":"OG002","value":"20.6"},{"groupId":"OG003","value":"32.7"},{"groupId":"OG004","value":"13.3"},{"groupId":"OG005","value":"27.4"}]}],"title":"Percentage of Patients w Grade 3 Diarrhea"}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"136"},{"groupId":"OG003","value":"104"},{"groupId":"OG004","value":"60"},{"groupId":"OG005","value":"62"}],"units":"Participants"}],"description":"Assess the percentage of patients with diarrhea after the administration of an anti-inflammatory agent, a bile acid sequestrant, or following two different dose-escalation regimens of neratinib, by maximum CTC grade. Grade 1: an increase of \\<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Grade 3: Increase of \\>=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death.","groups":[{"description":"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed.\n\nNeratinib\n\nLoperamide","id":"OG000","title":"Loperamide"},{"description":"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter.\n\nNeratinib\n\nLoperamide\n\nBudesonide: 9 mg extended release tablets once daily with or without food for 28 days","id":"OG001","title":"Budesonide and Loperamide"},{"description":"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter.\n\nNeratinib\n\nLoperamide\n\nColestipol: 2 g twice daily with or without food for one 28 day cycle","id":"OG002","title":"Colestipol and Loperamide"},{"description":"240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed.\n\nNeratinib\n\nLoperamide\n\nColestipol: 2 g twice daily with or without food for one 28 day cycle","id":"OG003","title":"Colestipol With Loperamide as Needed"},{"description":"120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed.\n\nNeratinib\n\nLoperamide","id":"OG004","title":"Neratinib Dose Escalation 1"},{"description":"160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only.\n\nNeratinib\n\nLoperamide","id":"OG005","title":"Neratinib Dose Escalation 2"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From first dose of investigational product through 28 days after last dose, up to 15.5 months.","title":"Percentage of Patients With Diarrhea by Grade, According to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), Version 4.0.","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}