[c09aa8]: / templates / fillins / 542.txtFILLINS.csv

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1 3 impairment of gastrointestinal function 33 gi disease that may significantly alter the absorption of the study drugs e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 13 or small bowel resection 50
2 57 impairment of gastrointestinal gi function 27 gi disease that may significantly alter the absorption of study drug e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 10 10
3 56 patient has impairment of gastrointestinal gi function 15 gastrointestinal disease that may significantly alter the absorption of everolimus e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 8 small bowel resection 9
4 68 impaired gastrointestinal gi function 11 gi disease that may significantly alter the absorption of bkm120 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 7 small bowel resection or gastric bypass surgery 8
5 13 inability to swallow 3 gastrointestinal disease e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 5 or small bowel resection patients with unresolved diarrhea will be excluded as previously indicated 8
6 22 patients must be able to take oral medications patient may not have any impairment of gastrointestinal function 3 4 or significant small bowel resection 4
7 60 patient is not able to swallow oral medication and / 3 gi disease that may significantly alter the absorption of oral byl719 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 4 or small bowel resection . 4
8 69 patient has impairment of gi function 3 gastrointestinal disease that may significantly alter the absorption of drugs e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 3 or small bowel resection that womcLd preclude use of oral medications 3
9 1 patients must be able to take oral medications patients may not have any impairment of gastrointestinal function 2 has impairment of gastrointestinal gi function or gi disease that may significantly alter the absorption of the study drugs e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 3 . 3
10 4 inability to take oral medication 2 gi disease that may significantly alter the absorption of ceritinib e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea or 3 or small bowel resection a nasogastric tube ng tube or gastric tube g tube is allowed 2
11 26 patients with impairment of gastrointestinal function 2 gastrointestinal disease that may significantly alter the absorption of palbociclib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 2 small bowel resection uncontrolled nausea or vomiting or grade > = 3 diarrhea of any etiology based on treating physician assessment 2
12 28 impaired gastrointestinal function 2 gastrointestinal disease that may significantly alter the absorption of rad001 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 2 or extensive small bowel resection 2
13 54 2 impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 2 or extensive small bowel resection participants with unresolved diarrhea > = ctcae grade 2 will be excluded as previously indicated 2
14 58 patient is unable to swallow oral medications 2 poorly controlled gastrointestinal disease that may significantly alter the absorption of oral byl719 e . g . crohn s disease mcLcerative colitis 2 or small bowel resection are not eligible for participation 2
15 59 known impairment of gastrointestinal gi function 2 gastrointestinal disease that may significantly alter the absorption of study drugs e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 2 or any other uncontrolled gastrointestinal condition eg nausea diarrhea or vomiting that might impair the bioavailability of e7046 1
16 62 participants with impairment of gastrointestinal gi function 2 gastrointestinal disease e . g . active mcLcerative disease uncontrolled nausea vomiting diarrhea 2 or small bowel resection a nasogastric tube ng tube is allowed 1
17 81 patient with impaired gastrointestinal gi function 2 gi disease that may significantly alter the absorption of onc201 uncontrolled nausea vomiting diarrhea 2 or small bowel resection that under the judgment of the principal investigator pi may impair absorption of study drugs 1
18 107 patients with impaired gastrointestinal gi function 2 gi disease that may significantly alter the absorption of oral bgj398 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 2 or small bowel resection sufficient to impair absorption of drug 1
19 2 patients must be able to take oral medications patients must not have any impairment of gastrointestinal function 1 gi disease that may significantly alter the absorption of study drug e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 2 small bowel resection note gastric bypass is allowed 1
20 27 patients may not have any impairment of gastrointestinal function 1 gastrointestinal disease that may significantly alter the absorption of blinded drug e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 or small bowel resection are not eligible to participate in this study 1
21 33 patients with an impairment of gastrointestinal function 1 gastrointestinal disease that may significantly alter the absorption of protocol treatment e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 or any other uncontrolled gastrointestinal condition eg nausea diarrhea or vomiting that might impair the bioavailability of lenvatinib or midazolam . 1
22 37 patient has impaired gastrointestinal function 1 gastrointestinal disease that may significantly alter the absorption of axitinib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 clinical signs and symptoms of gastrointestinal obstruction and / or patients who require parenteral hydration and / or nutrition . 1
23 39 patient may not have any impairment of gastrointestinal function 1 gastrointestinal disease that may significantly alter the absorption of cabozantinib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 mcLcerative diseases bowel resection with decreased intestinal absorption 1
24 49 current impairment of gastrointestinal function 1 gastrointestinal disease that may significantly alter the absorption of rad001 i . e . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 or small bowel resection associated with malabsorption . 1
25 55 impaired gi function 1 gastrointestinal disease that may significantly alter drug absorption e . g . inflammatory bowel disease uncontrolled nausea vomiting diarrhea 1 extensive small bowel resection 1
26 63 participant has impairment of gastrointestinal gi function 1 gastrointestinal disease that may significantly alter the absorption of gdc 0032 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 small bowel resection with decreased intestinal absorption 1
27 73 any impairment of gastrointestinal gi function 1 gastrointestinal disease that may significantly alter the absorption of azd4547 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 note concomitant therapy with proton pump inhibitors and / or h2 receptor antagonists is permissible 1
28 86 ongoing gi adverse events > = grade 2 e . g . nausea vomiting 1 gastrointestinal disease that may significantly alter the absorption of everolimus / lapatinib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 obstruction or stomach and / or small bowel resection 1
29 91 patient has impaired gastrointestinal gi function 1 gastrointestinal disease that may significantly alter the absorption of abt 888 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 small bowel resection including dependence on a gastrostomy g tube for administration of medications 1
30 94 gastrointestinal gi disease 1 gastrointestinal disease that may significantly alter the absorption of talazoparib bmn 673 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 or major small bowel resection 1
31 99 subject has impairment of gastrointestinal gi function 1 gastrointestinal disease e . g . uncontrolled mcLcerative disease uncontrolled nausea vomiting diarrhea chronic 1 or inability to swallow up to five ceritinib capsmcLes daily 1
32 130 inability to take oral medications e . g . impairment of gastrointestinal gi function 1 gastrointestinal disease that may significantly alter the absorption of everolimus e . g . mcLcerative disease uncontrolled nausea vomiting and / or diarrhea 1 small bowel resection that requires nutritional support 1
33 5 NA gastrointestinal disease that may significantly alter the absorption of oral medications e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 or small bowel resection patients with unresolved diarrhea will be excluded 1
34 6 NA gastrointestinal disease e . g . uncontrolled nausea vomiting diarrhea 1 small bowel resection within last 1 year or gastric bypass surgery within last 1 year 1
35 7 NA gastrointestinal disease that may significantly alter the absorption of study medication e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 small bowel resection including dependence on a gastrostomy tube g tube for administration of medications 1
36 8 NA gastrointestinal disease affecting absorption of buparlisib e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 or gastric or small bowel resection 1
37 9 NA gastrointestinal disease that comcLd interfere with the absorption of aeb071 or byl719 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 concomitant therapy with antacids and anti emetics is permissible 1
38 10 NA gastrointestinal disease that may significantly alter the absorption of the drug e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
39 11 NA gastrointestinal disease that may significantly alter the absorption of pd 0325901 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
40 12 NA impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea > = common terminology criteria for adverse events ctcae grade 2 1 NA
41 14 NA gastrointestinal disease that may significantly alter the absorption of bibf 1120 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
42 15 NA gastrointestinal disease that may significantly alter the absorption of sirolimus e . g . active mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
43 16 NA disease that may significantly alter the absorption of encorafenib or binimetinib e . g . mcLcerative diseases uncontrolled vomiting 1 NA
44 17 NA has impairment of gastrointestinal gi function or gi disease that may significantly alter drug absorption e . g . active inflammatory bowel disease uncontrolled nausea vomiting diarrhea or 1 NA
45 18 NA gi disease that may significantly alter the absorption of the study drugs e . g . uncontrolled mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
46 19 NA gi disease that may significantly alter the absorption of dabrafenib and trametinib in the opinion of the treating investigator e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
47 20 NA gi disease that may significantly alter the absorption of h3b 6545 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
48 21 NA gi disease that may significantly alter the absorption of vemurafenib and cobimetinib in the opinion of the treating investigator e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
49 23 NA gi disease that may significantly alter the absorption of inc280 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea or 1 NA
50 24 NA gi disease that may significantly alter the absorption of oral alpelisib e . g . uncontrolled nausea vomiting diarrhea 1 NA
51 25 NA gi disease that may significantly alter the absorption of panobinostat or dexamethasone e . g . mcLcerative disease uncontrolled nausea vomiting 1 NA
52 29 NA gi disease that may significantly alter the absorption of study medications e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
53 30 NA gi disease that may significantly alter the absorption of orally administered medication e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea or 1 NA
54 31 NA gi disease that may significantly alter the absorption of the study drugs e . g . mcLcerative diseases uncontrolled nausea / vomiting / diarrhea 1 NA
55 32 NA gi disease that may significantly alter the absorption of ceritinib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea or 1 NA
56 34 NA gi disease that may significantly alter the absorption of oral drug e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
57 35 NA gi disease that may significantly alter the absorption of azd1775 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
58 36 NA diarrhea at the start of the study patient has impairment of gi function or gi disease that may significantly alter the absorption of ceritinib e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea or 1 NA
59 38 NA gi disease that may significantly alter the absorption of oral alpelisib e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
60 40 NA impairment of gi function e . g . active mcLcerative disease uncontrolled nausea vomiting or diarrhea 1 NA
61 41 NA gi disease that may significantly alter the absorption of abemaciclib e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
62 42 NA gi disease that may significantly alter the absorption of oral mln0128 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
63 43 NA gi disease that may significantly alter the absorption of mocetinostat e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
64 44 NA gi disease that may significantly alter absorption of oral capecitabine e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
65 45 NA gi disease that may significantly alter the absorption of bkm120 or byl719 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
66 46 NA gi disease that may significantly alter the absorption of buparlisib eg mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
67 47 NA gi disease that may significantly alter the absorption of drug e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
68 48 NA active gi disease that may significantly alter the absorption of study drug in the opinion of the treating physician e . g . active mcLcerative diseases uncontrolled nausea uncontrolled vomiting uncontrolled diarrhea active 1 NA
69 50 NA gi disease that may significantly alter the absorption of mek162 e . g . mcLcerative disease uncontrolled nausea vomiting diarrhea 1 NA
70 51 NA gi disease that may significantly alter the absorption of wnt974 e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
71 52 NA gi disease that may significantly alter the absorption of dovitinib e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
72 53 NA gi disease that may significantly alter the absorption of oral medications e . g . mcLcerative diseases uncontrolled nausea vomiting diarrhea 1 NA
73 61 NA has impairment of gastrointestinal gi function or gi disease that may significantly alter drug absorption including but not limited to active inflammatory bowel disease 1 NA