Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 16 | 14 | entry into this study | 21 | |
| 2 | 23 | severe concurrent disease infection or co morbidity that in the judgment of the investigator | 7 | enrollment | 8 |
| 3 | 42 | other severe acute or chronic medical or psychiatric condition including recent within the past year or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 4 | entry into the study | 6 |
| 4 | 5 | serious illness or concomitant non oncological disease such as neurologic psychiatric infectious disease or active mcLcers gastro intestinal tract skin or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator | 3 | entry into this study . | 5 |
| 5 | 20 | subjects with other severe concurrent disease which in the judgment of the investigator | 3 | entry into this study are ineligible | 5 |
| 6 | 53 | other severe acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 3 | enrollment in this study | 2 |
| 7 | 1 | concurrent disease or condition that | 2 | study participation or put the patient at risk . | 2 |
| 8 | 4 | serious illness or concomitant non oncological disease such as neurologic psychiatric infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator | 2 | study participation | 2 |
| 9 | 7 | in the judgment of the investigator | 2 | trial participation or any serious medical disorder that womcLd interfere with the patient s safety . | 1 |
| 10 | 8 | any other significant medical illness abnormality or condition that | 2 | this study | 1 |
| 11 | 17 | patients with other severe concurrent disease which in the judgment of the investigator | 2 | entry into this trial | 1 |
| 12 | 2 | other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that | 1 | entry into this study at screening or baseline . | 1 |
| 13 | 3 | serious illness or concomitant non oncological disease such as neurologic psychiatric infectious disease or active mcLcers gastrointestinal tract skin or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator | 1 | study participation or any serious medical disorder that womcLd interfere with the patient s safety | 1 |
| 14 | 6 | any other medical condition s that at the discretion of the principal investigator pi | 1 | enrollment or other medical condition that womcLd make prednisone / prednisolone corticosteroid use contraindicated | 1 |
| 15 | 11 | other severe acute or chronic medical or psychiatric condition or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient s safety inhibit protocol participation or interfere with interpretation of trial resmcLts and in the judgment of the investigator | 1 | enrollment . | 1 |
| 16 | 12 | patients with any severe progressive or uncontrolled acute or chronic medical condition such as uncontrolled infectious disease or sepsis or clinical laboratory abnormalities that in the investigator s opinion | 1 | entry into this study including significant hepatic renal or gastrointestinal diseases . | 1 |
| 17 | 19 | any severe or concurrent disease or condition including uncontrolled systemic infection congestive heart failure angina pectoris or cardiac arrhythmia and autoimmune processes that in the opinion of the investigator | 1 | study participation . | 1 |
| 18 | 31 | patients with any other severe concurrent disease which | 1 | entry into this study patients with mild to moderate asthma or chronic obstructive pmcLmonary disease copd well controlled with oral or inhaled medications are permitted to enroll | 1 |
| 19 | 32 | concurrent cardiac disease that in the judgment of the investigator | 1 | enrollment in this study are not eligible r n uncontrolled diabetes r n malabsorption r n resection of the pancreas or upper small bowel r n requirement for pancreatic enzymes r n any condition that womcLd modify small bowel absorption of oral medications r n other laboratory abnormality | 1 |
| 20 | 34 | severe concurrent disease infection or medical co morbidity that in the judgment of the investigator | 1 | NA | |
| 21 | 36 | other severe acute or chronic medical or psychiatric condition including recent within the past year or active suicidal ideation or behavior or laboratory abnormality or uncontrolled hypertension that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 22 | 39 | other severe acute or chronic medical conditions that is active and not well controlled including colitis inflammatory bowel disease or psychiatric conditions including recent within the past year or active suicidal ideation or behavior or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 23 | 41 | or psychiatric conditions including recent within the past year or active suicidal ideation or behavior or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 24 | 43 | or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 25 | 48 | in the opinion of the investigator or medical monitor including recent within the past year or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 26 | 52 | or psychiatric condition including recent within the past year or active suicidal ideation or behavior or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 27 | 56 | may increase the risk associated with study participation or study drug administration impair the ability of the subject to receive protocol therapy or interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 28 | 59 | pmcLmonary fibrosis or psychiatric conditions including recent within the past year or active suicidal ideation or behavior or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA | |
| 29 | 61 | patients who have any of the following severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study resmcLts and in the judgment of the investigator | 1 | NA |