{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.1","upperLimit":"39.1","value":"30.7"},{"groupId":"OG001","lowerLimit":"17.6","upperLimit":"40.8","value":"28.1"},{"groupId":"OG002","lowerLimit":"14.1","upperLimit":"28.4","value":"20.6"},{"groupId":"OG003","lowerLimit":"23.8","upperLimit":"42.6","value":"32.7"},{"groupId":"OG004","lowerLimit":"5.9","upperLimit":"24.6","value":"13.3"},{"groupId":"OG005","lowerLimit":"16.9","upperLimit":"40.2","value":"27.4"}]}]}],"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":"The primary objective of this study is to characterize the percentage of patients with Grade 3 or higher diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. 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.","dispersionType":"95% Confidence Interval","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 Grade 3 or Higher Diarrhea, According to NCI CTCAE v4.0.","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}