Informed Consent
Item
patients must give written informed consent by signing an irb/ec-approved informed consent form (icf) prior to admission to this study
boolean
C0021430 (UMLS CUI [1])
Patients Treated Clinical Trial Specified
Item
patients who are being treated in study c-788-006x
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Patients Clinical Trial Specified Completion | Absence Patient withdrawn from trial Due to Adverse event
Item
patients who completed studies c-788-010 or c-788-011 and did not withdraw due to adverse events
boolean
C0030705 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0877248 (UMLS CUI [2,4])
Patient withdrawn from trial specified | Etiology Lack of Efficacy
Item
patients who withdrew from study c-788-010 at month 4 or month 5 because of a pre-defined lack of efficacy
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
Childbearing Potential Informed R788 compound | Childbearing Potential Sexually active Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Oral Hormonal Contraceptives Active Long-term | Childbearing Potential Breast Feeding Absent | Childbearing Potential Pregnancy test negative
Item
females of childbearing potential must be fully informed of the potential for r788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). these patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.
boolean
C3831118 (UMLS CUI [1,1])
C1522154 (UMLS CUI [1,2])
C2002836 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0009907 (UMLS CUI [5,1])
C0205177 (UMLS CUI [5,2])
C0443252 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0006147 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C3831118 (UMLS CUI [7,1])
C0427780 (UMLS CUI [7,2])
Comorbidity Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Exception Arthritis | Laboratory test result abnormal Affecting Completion of clinical trial
Item
the patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study. specifically, excluded are patients with the following:
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0003864 (UMLS CUI [3,2])
C0438215 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C2732579 (UMLS CUI [4,3])
Toxicity CTCAE Grades | Resolution Lacking
Item
1. unresolved grade 2 or greater toxicity in a ra protocol studying r788
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514893 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Uncontrolled hypertension | Poor hypertension control
Item
2. uncontrolled or poorly controlled hypertension;
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Operative Surgical Procedures Serious | Communicable Disease Serious
Item
3. recent (within past 2 months) serious surgery or infectious disease;
boolean
C0543467 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Lymphoma
Item
4. recent history (since enrollment in prior r788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0024299 (UMLS CUI [4])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity | Tuberculosis test positive
Item
5. known to be positive for hepatitis b, hepatitis c, hiv or tuberculosis;
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C1739367 (UMLS CUI [4])
Pneumonia, Interstitial | Infectious disease of lung
Item
6. interstitial pneumonitis or active pulmonary infection;
boolean
C0206061 (UMLS CUI [1])
C0876973 (UMLS CUI [2])
Laboratory test result abnormal | Alanine aminotransferase increased | Serum creatinine raised | Absolute neutrophil count | Lymphocyte Count measurement | Hemoglobin measurement | Platelet Count measurement
Item
7. known laboratory abnormalities: alt > 1.2 x uln, creatinine >1.5x uln, an anc <2,500/mm3 or 2.5 x 109/l, lymphocyte count < 600/mm3 or 0.6 x 109l, hgb < 9 g/dl or 5 mmol/l, platelet count <125,000/mm3 or 125 x 109/l are excluded.
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0200635 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
Substance Use Disorders | Drug Dependence | Alcoholic Intoxication, Chronic | Alcohol consumption U/week | Beer Alcohol unit | Wine Alcohol unit | Dessert wine Alcohol unit | Distilled spirits Alcohol unit
Item
the patient has a history of substance abuse, drug addiction or alcoholism. patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. patients who cannot reliably comply with this should be excluded. a unit of alcohol is defined as the following: beer = 12 oz or 355 ml; wine = 5 oz or 148 ml; sweet dessert wine = 3 oz or 89 ml; 80 proof distilled spirits = 1.5 oz or 44 ml.
boolean
C0038586 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0004922 (UMLS CUI [5,1])
C0556604 (UMLS CUI [5,2])
C0043188 (UMLS CUI [6,1])
C0556604 (UMLS CUI [6,2])
C0454276 (UMLS CUI [7,1])
C0556604 (UMLS CUI [7,2])
C0301611 (UMLS CUI [8,1])
C0556604 (UMLS CUI [8,2])
Report Monitoring Clinical Unable | Report Laboratory Monitoring Unable
Item
the patient is unable to report for clinical and laboratory monitoring as per protocol.
boolean
C0700287 (UMLS CUI [1,1])
C1283169 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0700287 (UMLS CUI [2,1])
C0022877 (UMLS CUI [2,2])
C1283169 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])