Pregnancy test negative | Postmenopausal state | Female Sterilization | Contraceptive methods
Item
patient must have a negative pregnancy test at screening and be postmenopausal for at least 1 year or surgically sterile or practicing a medically recognized contraceptive program
boolean
C0427780 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Osteoarthritis, Knee | Osteoarthritis of hip | Kellgren-Lawrence score
Item
patient has been diagnosed with functional class i-iii osteoarthritis of the knee or hip
boolean
C0409959 (UMLS CUI [1])
C0029410 (UMLS CUI [2])
C3177117 (UMLS CUI [3])
Therapeutic procedure Pain Target Joint | Pain control Target Joint Unable | Analgesics, Non-Narcotic | Medical contraindication Therapeutic procedure | Opioid Single | Opioids Combined | Morphine Sulfate Oral | Breakthrough Pain Pharmaceutical Preparations
Item
patient has required treatment of target joint pain within the 90 days prior to study start and met at least one of the following: was unable to consistently control target joint pain with non-opioid pain reliever, unable to treat target joint pain with non-opioid pain reliever because treatment was contraindicated per investigator judgement, or had received an opioid(single or combination product) for treatment of target joint pain, with the equivalent of less than or equal to 40 mg/day of oral morphine sulfate, inclusive of breakthrough pain medication
boolean
C0087111 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,4])
C0002766 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0242937 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0242402 (UMLS CUI [5,1])
C0205171 (UMLS CUI [5,2])
C0242402 (UMLS CUI [6,1])
C0205195 (UMLS CUI [6,2])
C0066814 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C1135120 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
Pain Target Joint | Pain Rating Likert Scale
Item
patient has reported a target joint pain score of at least 5 (11-point likert scale) at baseline
boolean
C0030193 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C3899970 (UMLS CUI [2])
Medical contraindication Hydromorphone | Allergic Reaction Hydromorphone | Urticaria | Exanthema | intolerance Clinical Significance Hydromorphone | intolerance Clinical Significance Opioids
Item
patient for whom hydromorphone was contraindicated because of a documented history of an allergic reaction (hives, rash, etc) or a clinically significant intolerance to hydromorphone or other opioids
boolean
C1301624 (UMLS CUI [1,1])
C0012306 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0012306 (UMLS CUI [2,2])
C0042109 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0012306 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C2826293 (UMLS CUI [6,2])
C0242402 (UMLS CUI [6,3])
Monoamine Oxidase Inhibitors Patient need for | Systemic Chemotherapy | Malignant Neoplasms | Clinical Chemistry Abnormality Clinical Significance | Hematology Abnormality Clinical Significance | Urinalysis Abnormality Clinical Significance | Gout | Pseudogout | Paget's Disease | Fibromyalgia
Item
patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic chemotherapy or had an active malignancy of any type or had clinically significant abnormalities in clinical chemistry, hematology or urinalysis, or had a documented history of gout, pseudogout, paget's disease, fibromyalgia
boolean
C0026457 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C1883256 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C2347783 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C2826293 (UMLS CUI [4,3])
C0200627 (UMLS CUI [5,1])
C1704258 (UMLS CUI [5,2])
C2826293 (UMLS CUI [5,3])
C0042014 (UMLS CUI [6,1])
C1704258 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
C0018099 (UMLS CUI [7])
C0033802 (UMLS CUI [8])
C1368019 (UMLS CUI [9])
C0016053 (UMLS CUI [10])
Arthritis Uncontrolled | Arthritis Non-Steroidal Anti-Inflammatory Agents Dependent | Chronic pain syndrome Interferes with Pain Measurement | Osteoarthritis Symptoms
Item
uncontrolled inflammatory arthritis or nsaid-dependent inflammatory arthritis or any chronic pain syndrome that could interfere with the assessment of pain and/or other symptoms of osteoarthritis
boolean
C0003864 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003864 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C0851827 (UMLS CUI [2,3])
C1298685 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0030198 (UMLS CUI [3,3])
C0029408 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
patient who is pregnant and/or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Drug abuse | Drug Dependence | Narcotic Analgesics Abuse | Narcotic Analgesics Dependence | Narcotic Analgesics MISUSE | Analgesics Formulations Discontinue Unable | Opioids | Analgesics, Non-Narcotic
Item
patient with a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior pain medications (opioid and/or non-opioid) during the washout period of the study
boolean
C0013146 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0027409 (UMLS CUI [3,1])
C1546935 (UMLS CUI [3,2])
C0027409 (UMLS CUI [4,1])
C0439857 (UMLS CUI [4,2])
C0027409 (UMLS CUI [5,1])
C0549649 (UMLS CUI [5,2])
C0002771 (UMLS CUI [6,1])
C0013058 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
C1299582 (UMLS CUI [6,4])
C0242402 (UMLS CUI [7])
C0242937 (UMLS CUI [8])
Medical condition Able to swallow Investigational Drug Limited | Medical condition Drug absorption Limited | Medical condition Metabolic Process Investigational Drug Limited | Medical condition Excretion Investigational Drug Limited | NAUSEA INTRACTABLE | Intractable vomiting | Narrowing gastrointestinal Severe
Item
patient who had a documented history of a medical condition, which, in the investigator's opinion, could compromise the patient's ability to swallow, absorb, metabolize, or excrete study drug, including (but not limited to) intractable nausea and/or vomiting, and/or severe gastrointestinal narrowing
boolean
C3843040 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0678745 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1524026 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0439801 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0221102 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C0439801 (UMLS CUI [4,4])
C0746781 (UMLS CUI [5])
C0750323 (UMLS CUI [6])
C0332463 (UMLS CUI [7,1])
C0521362 (UMLS CUI [7,2])
C0205082 (UMLS CUI [7,3])