Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 10 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 57 | or pituitary insufficiency etc . is not considered a form of systemic treatment | 164 |
| 2 | 37 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 41 | dysfunction | 18 |
| 3 | 267 | history of pituitary or | 15 | or pituitary insufficiency etc . is not considered a form of systemic treatment . | 17 |
| 4 | 245 | uncontrolled | 9 | insufficiency | 11 |
| 5 | 275 | history of documented | 6 | or pituitary insufficiency is not considered a form of systemic treatment for autoimmune disease | 6 |
| 6 | 2 | patients must not have active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | dysfunction not due to malignancy . | 6 |
| 7 | 26 | active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | or pituitary insufficiency is not considered a form of systemic treatment . | 5 |
| 8 | 47 | has an active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | or pituitary insufficiency is not considered a form of systemic treatment | 5 |
| 9 | 48 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | insufficiency or active chronic liver disease | 3 |
| 10 | 64 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | or pituitary insufficiency etc . is allowed . | 2 |
| 11 | 83 | has active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 5 | or pituitary insufficiency etc . is not considered a form of systemic treatment subjects that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study | 2 |
| 12 | 240 | history of | 5 | or pituitary insufficiency etc . is not considered a form of systemic treatment and is allowed | 2 |
| 13 | 28 | thyroxine for hypothyroidism insmcLin for diabetes or physiologic corticosteroid replacement therapy for | 4 | or pituitary insufficiency etc is not considered a form of systemic treatment | 2 |
| 14 | 70 | insmcLin for diabetes or physiologic corticosteroid replacement therapy for | 4 | dysfunction active or symptomatic viral hepatitis or chronic liver disease are not eligible | 2 |
| 15 | 19 | patient has an active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n notes r n patients with vitiligo grave s disease or psoriasis not requiring systemic treatment within the past 2 years are not excluded r n replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 3 | or pituitary insufficiency is allowed patients with active interstitial lung disease or who have a history of pneumonitis for which they had received glucocorticoids are not eligible . | 1 |
| 16 | 45 | has an active autoimmune disease requiring systemic treatment within the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 3 | her pituitary insufficiency etc . is not considered a form of systemic treatment | 1 |
| 17 | 61 | active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 3 | or pituitary insufficiency is not considered a form of systemic treatment for autoimmune disease . | 1 |
| 18 | 270 | known history of pituitary or | 3 | or pituitary insufficiency | 1 |
| 19 | 1 | active autoimmune disease that has required systemic treatment in the past 2 years ie with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 2 | or pituitary insufficiency is acceptable | 1 |
| 20 | 24 | participant has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication for example patients with autoimmune disease that requires systemic steroids or immunosuppression agents shomcLd be excluded replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 2 | or pituitary insufficiency etc . is not considered a form of systemic treatment and is allowed . | 1 |
| 21 | 60 | has an active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 2 | or pituitary insufficiency etc . is not considered a form r nof systemic treatment | 1 |
| 22 | 69 | has active autoimmune disease that has required systemic treatment in the past 1 year i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 2 | or pituitary insufficiency etc . is not considered a systemic treatment subjects on stable dose of corticosteroids less than or equivalent to 10mg of prednisone daily for more than 3 months may be enrolled and continue their stable dose through treatment | 1 |
| 23 | 85 | has active autoimmune disease requiring systemic treatment in the past 2 years ie with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteriod replacement therapy for | 2 | or pituitary insufficiency etc . is not considered a form of systemic treatment any patient bearing an allograft is not eligible | 1 |
| 24 | 160 | active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 2 | or pituitary insufficiency etc . is not considered a form of systemic treatment patients with allografts including liver transplants are not eligible for this protocol | 1 |
| 25 | 250 | immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for | 2 | or pituitary insufficiency etc . is not considered a systemic treatment | 1 |
| 26 | 272 | patients with a history of pituitary or | 2 | or pituitary insufficiency etc . is not considered a form of systemic treatment a history of hemolytic anemia associated with the lymphoma does not exclude a patient from the study | 1 |
| 27 | 4 | patients who received prior pembrolizumab patients on chronic steroids or who have active autoimmune disease for which they received systemic treatment in the previous 2 years with corticosteroids disease modifying agents or immunosuppressive drugs replacement therapy thyroxine insmcLin or physiological corticosteroid replacement for | 1 | or pituitary insufficiency etc . is allowed | 1 |
| 28 | 6 | no active autoimmune disease that has required systemic treatment in past 2 years ie with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | gland or pituitary insufficiency or treatment with drugs e . g . neomercazole carbamazole | 1 |
| 29 | 7 | replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . are not considered a form of systemic treatment | 1 |
| 30 | 8 | autoimmune disease that has required systemic treatment in the past i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment for patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation r n the use of inhaled or oral corticosteroids and mineralocorticoids e . g . fludrocortisone for patients with orthostatic hypotension or adrenocortical insufficiency is allowed | 1 |
| 31 | 9 | active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus rheumatoid arthritis mmcLtiple sclerosis sjogren s syndrome or autoimmune thrombocytopenia . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment conditions expected to not recur in the absence of an external trigger | 1 |
| 32 | 12 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment that womcLd be exclusionary | 1 |
| 33 | 13 | patients with autoimmune disease or medical conditions that required systemic corticosteroids > = 10 mg / day prednisone or its equivalent or other immunosuppressive medications or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment . note replacement therapy e . g . physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment asthma type i diabetes mellitus hypothyroidism and vitiligo are allowed | 1 |
| 34 | 16 | the subject has a medical condition that requires chronic systemic steroid therapy or any other form of immunosuppressive medication including disease modifying agents replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment immunosuppressive corticosteroid doses > = 10 mg prednisone daily or equivalent within 4 weeks prior to the first dose of pembrolizumab note corticosteroids given within 24 hours of an imaging study for purposes of pre medication in patients with hypersensitivity to radiologic contrast agents are allowed | 1 |
| 35 | 20 | cohort 1 has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment subjects are permitted to enroll if they have vitiligo type i diabetes mellitus residual hypothyroidism due to autoimmune condition only requiring hormone replacement | 1 |
| 36 | 21 | cohort 2 has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment anti coagmcLants are permitted | 1 |
| 37 | 23 | participant has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication . for example patients with autoimmune disease that requires systemic steroids or immunosuppression agents shomcLd be excluded . replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency is permitted . | 1 |
| 38 | 25 | active auto immune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment note subjects with vitiligo or resolved childhood asthma / atopy womcLd be an exception to this rmcLe . subjects that require intermittent use of bronchodilators or local steroid injections womcLd not be excluded from the study | 1 |
| 39 | 27 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with the use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment topical and inhaled corticosteroids are allowed | 1 |
| 40 | 29 | patients who have active autoimmune disease that has required systemic treatment in the past 2 years are not eligible i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic immunosuppressive treatment | 1 |
| 41 | 34 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents . note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment patients with previous grade iii / iv toxicity from immunotherapy that led to treatment discontinuation are excluded | 1 |
| 42 | 35 | active autoimmune disease that has required systemic treatment in past 2 years replacement therapy such as thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency is not considered a form of systemic treatment for autoimmune disease r n evidence of clinically significant immunosuppression such as r n primary immunodeficiency state such as severe combined immunodeficiency disease r n concurrent opportunistic infection r n receiving systemic immunosuppressive therapy > = 2 weeks including oral steroid doses > = 10 mg / day of prednisone or equivalent within 2 months prior to enrollment | 1 |
| 43 | 36 | the participant has a medical condition that requires chronic systemic steroid therapy or any other form of immunosuppressive medication including disease modifying agents replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic therapy | 1 |
| 44 | 43 | has active or documented history of autoimmune disease that has required systemic treatment in the preceding 2 years i . e . required use of disease modifying agents such as corticosteroids or other immunosuppressive drugs patients with psoriasis and rheumatoid arthritis with no evidence of disease flare off immunosuppression for > = 1 year may be allowed after discussion with the study pi replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment intraarticmcLar inhaled and intralesional doses of steroids are allowed at screening and during the study | 1 |
| 45 | 49 | has active autoimmune disease that has required systemic treatment 2 years prior to study registration i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc is not considered a form of systemic treatment . | 1 |
| 46 | 50 | has active autoimmune disease including myasthenic syndrome which has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency r netc . is not considered a form of systemic treatment | 1 |
| 47 | 53 | participants must not have active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroids replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment . subjects with vitiligo or resolved childhood asthma / atopy will not be excluded . | 1 |
| 48 | 54 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or r nphysiologic corticosteroid replacement therapy for | 1 | or pituitary insufficiency etc . is not considered a form of systemic treatment parts d and e only . | 1 |
| 49 | 67 | patient has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication for example participants with autoimmune disease that requires systemic steroids or immunosuppression agents shomcLd be excluded replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | insufficiency or hypoaldosteronism | 1 |
| 50 | 68 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine or physiologic corticosteroid replacement therapy for | 1 | insufficiency or patients receiving treatment with ketoconazole abiraterone or aminoglutethimide . | 1 |
| 51 | 76 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs with the exception of autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura itp replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | replacement indications maintenance steroid use for adrenal insufficiency is permitted | 1 |
| 52 | 81 | has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first study intervention apheresis replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | insufficiency . | 1 |
| 53 | 84 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy < 10 mg of prednisone / day for | 1 | insufficiency inhaled or intranasal corticosteroids for allergic or bronchospastic conditions are permitted | 1 |
| 54 | 96 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | insufficiency are not eligible | 1 |
| 55 | 101 | active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacment therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | insufficiency including subjects using replacement therapy | 1 |
| 56 | 102 | has active autoimmune disease that has required systemic treatment in the past year i . e . with use of steroids or immunosuppressive drugs replacement therapy e . g . levothyroxine insmcLin or physiologic corticosteroid doses for | 1 | insufficiency or patients currently requiring chronic systemic corticosteroid therapy at any dose for longer than 2 weeks . local steroid therapies eg otic ophthalmic intraarticmcLar or inhaled medications are acceptable | 1 |
| 57 | 104 | history or evidence of active autoimmune disease that requires systemic treatment ie with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | gland | 1 |
| 58 | 109 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with chronic use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | disease | 1 |
| 59 | 113 | patients must not have active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | insufficiency or inhaled steroids for the treatment of asthma | 1 |
| 60 | 116 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | neoplasm | 1 |
| 61 | 120 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or r nphysiologic corticosteroid replacement therapy for | 1 | insufficiency addison s disease or cushing s syndrome | 1 |
| 62 | 122 | subjects must not have autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | dysfunction active or symptomatic viral hepatitis or chronic liver disease | 1 |
| 63 | 128 | has active autoimmune disease that has required systemic treatment in the past 2 years ie with use of disease modifying agents supra physiologic doses of systemic corticosteroids or immunosuppressive drugs replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | disease or dysfunction | 1 |
| 64 | 137 | has active autoimmune disease that has required systemic treatment in the past 6 months i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | dysfunction . | 1 |
| 65 | 139 | active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | dysfunction or active or symptomatic viral hepatitis or chronic liver disease are not eligible | 1 |
| 66 | 141 | patients with an active autoimmune disease requiring ongoing systemic treatment i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs are not eligible r n note a minimum 14 day washout period is required for eligibility r n note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | dysfunction note the use of daily steroids does not exclude someone from participating in this study | 1 |
| 67 | 147 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids with higher than physiologic doses or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 68 | 151 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 69 | 153 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids in doses greater than 10 mg of prednisone daily or equivalent or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 70 | 158 | no active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 71 | 161 | patient is diagnosed with active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 72 | 163 | active autoimmune disease that has required systemic disease modifying or immunosuppressive treatment within the last 2 years . replacement therapy example thyroxine or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 73 | 165 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids in excess of prednisone 10 mg / 24 h equivalent or immunosuppressive drugs and womcLd represent significant morbidity risk in judgement of investigator replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 74 | 168 | active autoimmune disease active defined as having autoimmune disease related symptoms and detectable autoantibodies that has required systemic treatment in the past 2 years i . e . with use of diseasemodifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 75 | 170 | registration to treatment step 1 patient must not have active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 76 | 171 | history of symptomatic autoimmune disease or active autoimmune disease that has required systemic treatment in the 2 weeks prior to enrollment replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 77 | 174 | has active autoimmune disease that has required systemic large physiologic dose treatment in the past year i . e . with use of disease modifying agents corticosteroids or any other immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 78 | 179 | active autoimmune disease that has required systemic treatment within the past 2 years i . e . with use of modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 79 | 182 | active autoimmune disease requiring systemic treatment in the past 2 years i . e . use of disease modifying agents corticosteroids or immunosuppressive drugs note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 80 | 183 | participants with active autoimmune disease that has required systemic treatment > = than 5 mg of prednisone or its equivalent in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 81 | 184 | has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 82 | 185 | insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 83 | 190 | active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs r n note replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 84 | 194 | participant has a medical condition that requires chronic systemic steroid therapy > = 10 mg of prednisone daily or equivalent or any other form of immunosuppressive medication including disease modifying agents and has required such therapy in the last 2 years replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 85 | 196 | an active autoimmune disease that has required systemic treatment in the two years preceding the study i . e . with the use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 86 | 197 | active autoimmune disease that has required systemic treatment in past 2 years . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 87 | 198 | has an active autoimmune disease that has required systemic treatment in the past 2 years i . e . use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 88 | 207 | participant has active autoimmune disease that has required systemic treatment within the past 2 years eg with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 89 | 208 | no active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 90 | 209 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . note replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 91 | 210 | has an active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 92 | 211 | has an active autoimmune disease that has required systemic treatment in past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 93 | 212 | active autoimmune disease that has required systemic treatment in the past two years i . e . with use of disease modifying agents systemic corticosteroids or immunosuppressive drugs . replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 94 | 214 | active autoimmune disease with the exception of psoriasis that has required systemic treatment in the past 2 years ie with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 95 | 216 | has active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids exceeding 10 mg prednisone per day or its equivalent or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 96 | 217 | patients with active autoimmune disease that has required systemic treatment in the past 2 years i . e . with use of disease modifying agents corticosteroids or immunosuppressive drugs replacement therapy eg . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 97 | 219 | active autoimmune disease that has required systemic treatment in the past 2 years that is with use of disease modifying agents corticosteroids or immunosuppresive drugs . replacement therapy example thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 98 | 220 | active autoimmune disease that required systemic treatment in the past 2 years ie with use of disease modifying agents corticosteroids or immunosuppressive drugs . replacement therapy eg thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 99 | 221 | has an active autoimmune disease requiring systemic treatment within the past 2 years i . e . with use of disease modifying agents corticosteroids prednisone dose of 5 mg or less per day is allowed or immunosuppressive drugs replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA | |
| 100 | 225 | medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication for example participants with autoimmune disease that requires systemic steroids or immunosuppression agents shomcLd be excluded replacement therapy e . g . thyroxine insmcLin or physiologic corticosteroid replacement therapy for | 1 | NA |