{"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":"FG000","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":"FG001","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":"FG002","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":"FG003","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":"FG004","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":"FG005","title":"Neratinib Dose Escalation 2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"19"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"}],"type":"Other, Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Other, Decreased Quality of Life"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Other, Noncompliance to Protocol Requirements"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"137"},{"groupId":"FG001","numSubjects":"64"},{"groupId":"FG002","numSubjects":"136"},{"groupId":"FG003","numSubjects":"104"},{"groupId":"FG004","numSubjects":"60"},{"groupId":"FG005","numSubjects":"62"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"76"},{"groupId":"FG001","numSubjects":"52"},{"groupId":"FG002","numSubjects":"95"},{"groupId":"FG003","numSubjects":"74"},{"groupId":"FG004","numSubjects":"45"},{"groupId":"FG005","numSubjects":"46"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"41"},{"groupId":"FG003","numSubjects":"30"},{"groupId":"FG004","numSubjects":"15"},{"groupId":"FG005","numSubjects":"16"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}