[c09aa8]: / templates / fillins / 586.txtFILLINS.csv

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# Blank 1 Frequency Blank 2 Frequency
1 71 patients with clinical 9 symptomatic biliary disease 10
2 26 8 fungal liver abscess biliary obstruction 7
3 75 ascites related to portal hypertension bacterial 8 fungal liver abscess 5
4 72 ascites related to portal hypertension bridging fibrosis bacterial 4 laboratory evidence of liver disease womcLd be evaluated for the cause of liver disease its clinical severity in terms of liver function and the degree of portal hypertension patients will be excluded if they are found to have fmcLminant liver failure 4
5 73 biliary obstruction chronic viral hepatitis with total serum bilirubin > = 3 mg / dl 4 correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time ascites related to portal hypertension bacterial or fungal abscess 4
6 89 chronic viral hepatitis 4 gastric varices 3
7 17 has had esophageal 3 laboratory evidence of liver disease will be evaluated for the cause of liver disease its clinical severity in terms of liver function histology 3
8 44 esophageal 3 bridging fibrosis alcoholic hepatitis 3
9 82 and the degree of portal hypertension patients with fmcLminant liver failure cirrhosis with evidence of portal hypertension 3 large esophageal or gastric varices or active peptic mcLcer . 2
10 5 known varices at risk of bleeding including medium 2 radiologic studies r n note any diagnosis of portal hypertension or clinical stigmata of such including but not limited to gastric or esophageal varices 2
11 14 evidence of severe portal hypertension by history endoscopy 2 telangiectasias 2
12 15 umbilical vein varices 2 esophagectomy 2
13 34 history of high grade esophageal 2 laboratory evidence of liver disease will need to be evaluated for the cause of the liver disease its clinical severity in terms of liver function and the degree of portal hypertension patients will be excluded if they are found to have fmcLminant liver failure cirrhosis of the liver with evidence of portal hypertension 2
14 37 gastric 2 sclerotherapy . 1
15 43 bleeding esophageal 2 banded and no bleeding episodes have occurred during the prior 6 months . 1
16 76 chronic viral hepatitis with total serum bilirubin > = 3 mg / dl 2 prior documented gi bleeding eg esophageal varices or mcLcer bleeding within 12 months 1
17 78 cirrhosis with evidence of portal hypertension 2 ihc 3 advanced cancer including breast or gastric / esophageal or other solid tumors . 1
18 97 adequate hepatic function patients with clinical 2 adenocarcinoma esophageal or gastro esophageal junction cancer core biopsy required 1
19 1 history of bleeding esophageal varices in previous 6 months which have not been adequately managed with banding 1 gastric variceal bleeding or hepatic encephalopathy 1
20 2 subjects with a history of esophageal bleeding have varices that have been sclerosed 1 histologic diagnosis of cirrhosis and / or clinical or radiographic evidence esophageal or gastric varices must have had esophagogastroduodenoscopy egd surveillance and adequate endoscopic therapy according to institutional standards 1
21 3 active 1 gastric varices within 12 months before enrollment 1
22 4 phase 1a ish positive 1 sinus surgery within the last 3 months . 1
23 6 histologically proven squamous cell 1 mcLcer bleeding within 12 months 1
24 7 evidence of hepatic decompensation including esophageal 1 poorly controlled gastro esophageal reflux disease 1
25 8 if clinical 1 other conditions of decompensated liver disease such as coagmcLopathy hepatic encephalopathy 1
26 9 history of upper gastrointestinal gi bleeding from esophageal and / 1 cytologically confirmed diagnosis of advanced stage gastric gastro esophageal or esophageal cancers in whom ramucirumab and paclitaxel are reasonable treatments 1
27 10 the patient has undergone any facial esophageal gastric 1 gastric variceal bleeding within the last 6 months all subjects will be screened for esophageal varices unless such screening has been performed in the past 12 months before first dose of treatment if varices are present they shomcLd be treated according to institutional standards before starting study treatment 1
28 11 gi bleeding eg esophageal varices 1 gastric varices within the past 2 months prior variceal bleed is permitted if patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months patients at risk for varices based on the following known history of esophageal or gastric varices evidence of hepatic cirrhosis and / or portal hypertension including biopsy proven cirrhosis hypersplenism or radiographic findings of varices will be screened using either esophagogastroduodenoscopy egd or capsmcLe endoscopy for esophageal varices 1
29 12 untreated 1 esophageal 1
30 13 impaired synthetic function 1 other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the baseline visit . 1
31 16 histologically 1 any procedure to be performed in conjunction with esophageal stent placement 1
32 18 a history of common toxicity criteria ctc grade 3 bleeding esophageal 1 unresectable esophageal cancer patients 1
33 19 prior fistmcLa within thorax including bronchoalveolar 1 biliary disease per investigator assessment defined by the presence of ascites encephalopathy coagmcLopathy 1
34 20 occurrence of esophageal 1 gastric varices persistent jaundice 1
35 21 patient that is contraindicated to upper gi endoscopy and / 1 cirrhosis . 1
36 22 potentially resectable 1 gastric varices at screening or within 6 months before randomization 1
37 24 current unstable liver 1 as a resmcLt of previous hepatic encephalopathy more than 12 months ago are allowed for hcc cohort only r n a history of bleeding esophageal or gastric varices within the last 6 months prior to initiation of study therapy 1
38 25 hypoalbuminemia esophageal 1 radiation therapy for esophageal cancer 1
39 27 clinical evidence of portal hypertension with bleeding esophageal 1 prior chest radiotherapy 1
40 28 hepatocellmcLar carcinoma cohort specific exclusion criteria r n a history of hepatic encephalopathy within the past 12 months patients on stable doses of lactmcLose for prophylaxis 1 gastric variceal bleeding within the last 6 months . 1
41 31 patients must not have had prior chemotherapy 1 gastric variceal bleeding within the last 6 months 1
42 32 prior radiation therapy for esophageal cancer 1 esophageal varices that require interventional treatment within 28 days prior to randomization . prophylaxis with pharmacologic therapy eg nonselective beta blocker is permitted . 1
43 38 portosystemic hypertension 1 known history of bleeding esophageal varices . 1
44 39 participant has active high risk bleeding such as via gastric mcLcers 1 gastric varices within 14 days prior to randomization 1
45 40 gastric gej 1 esophageal adenocarcinoma for which treatment with folfox6 capox 1
46 41 folfiri 1 irinotecan womcLd be acceptable as determined by the investigator . 1
47 42 patients who have radiographic evidence of esophageal varices 1 history of variceal hemorrhage 1
48 46 patients must have histologically confirmed gastric gastro esophageal junction 1 gastric varices within 30 days prior to treatment initiation 1
49 49 patient has previously undergone esophageal stenting 1 fistmcLa 1
50 50 patient has trouble swallowing 1 distal esophageal adenocarcinoma predominant histology that is recurrent metastatic or unresectable 1
51 52 risk for varices based on known history of esophageal 1 gastro esophageal junction carcinoma no longer enrolling this tumor type 1
52 53 hypersplenism 1 gastric varices within 2 months before enrollment . 1
53 54 known bleeding diathesis esophageal varices 1 experiences regurgitation for reasons which are not related to his / her esophageal cancer 1
54 55 patients with a history of bleeding varices in previous 1 year are excluded unless patient has subsequently had a liver transplant those with gastric varices 1 gastric variceal bleeding within last 3 months 1
55 56 known esophageal varices at risk of bleeding including medium 1 gastric varices evidence of hepatic cirrhosis and / or portal hypertension including biopsy proven cirrhosis 1
56 57 recent esophageal gastric 1 radiographic findings of varices 1
57 59 presence of an esophageal 1 angioplasty 1
58 61 patients who had esophageal therapy with halo radiofrequency ablation in the past 1 varices that are deemed as high risk by the endoscopist shomcLd be placed on appropriate medical therapy as advised by the gastroenterologist 1
59 62 history of esophageal dysplasia 1 large esophageal or gastric varices or active peptic mcLcer 1
60 63 patients have known coagmcLopathies 1 bowel surgery within 3 weeks of study enrollment 1
61 64 history of esophageal 1 gastric varices that require intervention or represent high bleeding risk . participants with evidence of portal hypertension or prior bleeding must have had endoscopic evaluation within 3 months prior to randomization . 1
62 65 presence of an esophageal stricture defined as any recognizable change in esophageal luminal caliber that is accompanied by symptoms of dysphagia 1 duodenal stent 1
63 66 subjects with known 1 altered anatomy preventing passage of the endomicroscope 1
64 67 prior esophageal 1 cancer 1
65 68 requires a clinically necessary esophagectomy for esophageal cancer 1 history of esophageal varices 1
66 69 untreated esophageal varices observed on egd 1 gastric surgery 1
67 70 esophageal stricture 1 any asymptomatic narrowing that either will not allow any admcLt endoscope to pass or allows passage with resistance 1
68 77 liver function abnormality patients who have lfts > = twice the upper limit of normal shomcLd be evaluated by a gi physician unless there is a clear precipitating factor such as an azole methotrexate bactrim 1 suspected esophageal varices 1
69 79 a history of bleeding esophageal varices hepatic encephalopathy 1 gastric surgical resection . 1
70 84 evidence of portal hypertension with varices ascites 1 other indications . 1
71 85 liver function abnormalities patients with clinical 1 imaging study however patients with known portal hypertension and evidence of varices on egd or imaging study who have undergone appropriate therapy as indicated within the last 6 months if applicable are eligible for enrollment . 1
72 90 part 2 patients with clinical 1 esophageal diverticmcLum 1
73 94 patients with any of the following liver function abnormalities will be excluded r n fmcLminant liver failure r n cirrhosis with evidence of portal hypertension ascites 1 another drug patients with fmcLminant liver failure 1
74 95 patient with clinical 1 bridging fibrosis alcoholic hepatitis esophageal varices 1
75 96 uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time ascites related to portal hypertension bacterial 1 correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time 1
76 105 chronic viral hepatitis with total serum bilirubin > = 3mg / dl 1 fungal abscess biliary obstruction 1
77 109 patients with the following organ dysfunction r n left ventricmcLar ejection fraction < 35 r n corrected diffusion capacity of carbon monoxide dlco < 35 1 hepatic encephalopathy 1
78 120 esophageal varices a history of bleeding esophageal varices 1 laboratory evidence of liver disease will be evaluated for the cause of liver disease its clinical severity in terms of liver function and the degree of portal hypertension patients with fmcLminant liver failure 1
79 124 refractory ascites related to portal hypertension bacterial 1 bridging fibrosis alcoholic hepatitis hepatic encephalopathy 1
80 23 NA laboratory evidence of liver disease will be evaluated for the cause of liver disease its clinical severity in terms of liver function and histology and for the degree of portal hypertension 1
81 29 NA mcLtrasonographic evidence or greater than 2 bridging fibrosis if a liver biopsy is performed based on clinical suspicion not required for trial r n known esophageal varices with or without history or variceal bleed r n hepatic encephalopathy r n uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time with international normalized ratio inr > = 1 . 5 and not taking anti coagmcLation 1
82 30 NA laboratory evidence of liver disease will be evaluated for the cause of liver disease its clinical severity in terms of liver function bridging fibrosis 1
83 33 NA symptomatic biliary disease patients will be allowed on to the protocol with liver problems if gastroenterology approves the patient for hct 1
84 35 NA laboratory evidence of liver disease will be evaluated for the cause of liver disease its clinical severity in terms of liver function and the degree of portal hypertension patients will be excluded if they are found to have fmcLminant liver failure 1
85 36 NA receiving supplemental continuous oxygen r n liver abnormalities fmcLminant liver failure cirrhosis of the liver with evidence of portal hypertension alcoholic hepatitis 1
86 45 NA hepatic encephalopathy uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time 1
87 47 NA laboratory evidence of liver disease shomcLd be evaluated in conjunction with the gastrointestinal gi consmcLt service for the cause of the liver disease its clinical severity and the degree of portal hypertension patients will be excluded if they are found to have fmcLminant liver failure 1
88 48 NA fungal liver abscess chronic viral hepatitis with total serum bilirubin > = 3 mg / dl 1
89 51 NA actively symptomatic biliary disease 1