anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lansoprazole
Trial phase: Not Applicable
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 16
Group description: Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
Eligibility criteria:
Inclusion Criteria:

History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

Exclusion Criteria:

Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.
Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.
Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 621
Group description: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Eligibility criteria:
Inclusion Criteria:

Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor

Exclusion Criteria:

Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
Eligibility criteria:
Inclusion Criteria:

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria:

Type 2 diabetes
Current use of glycemic control medications within one month of randomization
Fasting glucose >126 mg/dL
Current use of weight loss medication
Previous weight loss surgery
History of severe gastrointestinal disease
Standard clinical contraindications to exenatide or metformin therapy
Unstable angina
Heart failure
Stroke or coronary artery bypass graft within 3 months of screening
Women who are currently pregnant or planning to become pregnant
Breastfeeding women
Clinically significant liver disease
Creatinine > 1.5 mg/dL
Hepatic function greater than 3 times upper limit of normal
Patients who are mentally incompetent and cannot sign a Patient Informed Consent
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 63
Group description: 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
Eligibility criteria:
Inclusion Criteria:

Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
Diagnosis of ADHD
Normal intelligence
Able to swallow capsules

Exclusion Criteria:

Weight less than 20 kg or more than 60 kg at study entry
Prior treatment with atomoxetine
History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
History of severe allergies or multiple adverse drug reactions
Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
Intervention: Nebivolol
Trial phase: Phase 3
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Nebivolol 5 mg, 10 mg or 20 mg
Eligibility criteria:
Inclusion Criteria:

Male or female, ambulatory outpatients
History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)
SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

Exclusion Criteria:

Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
Diabetes mellitus, type I or II
Participation in a previous investigational study of nebivolol at any time
Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1)
History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs
Intervention: Nortriptyline
Trial phase: Not Applicable
ATC code: N06AA10
SMILES: CNCCC=C1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Men and Women
Ages 18-65
Meet Rome III criteria for functional dyspepsia
Endoscopy within 1 year

Exclusion Criteria:

Allergic reaction or history of adverse events with Nortriptyline or tricyclic antidepressants
Organic cause found on physical examination
Organic cause found on lab work: Complete Blood Count, Comprehensive Metabolic Panel, Thyroid stimulating hormone, Tissue transglutaminase Immunoglobulin A
Predominantly Gastroesophageal reflux symptoms
Current Helicobacter pylori infection
History of Peptic ulcer disease
Non steroidal antiinflammatory use use > 2x/wk
Pregnant or planning pregnancy
History of major depression
Abdominal surgery in the last year
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 109
Group description: VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
Eligibility criteria:
Inclusion Criteria:

Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
Habitual bedtime between 9:00 pm and 1:00 am.
No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
Patients must sign a written consent form.

Exclusion Criteria:

History of drug or alcohol abuse as defined in DSM-IV.
History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
Recent history of shift work or jet lag.
Intervention: Tasimelteon
Trial phase: Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 109
Group description: VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
Eligibility criteria:
Inclusion Criteria:

Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
Habitual bedtime between 9:00 pm and 1:00 am.
No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
Patients must sign a written consent form.

Exclusion Criteria:

History of drug or alcohol abuse as defined in DSM-IV.
History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
Recent history of shift work or jet lag.
Intervention: Mercaptopurine
Trial phase: Phase 2
ATC code: L01BB02 | R03DA20
SMILES: S=c1nc[nH]c2nc[nH]c12
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 38
Group description: All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Eligibility criteria:
Inclusion Criteria:

B-lineage ALL
1-17.9 years
WBC <100, clinical remission obtained day 2
Written consent to participation.

Exclusion Criteria:

t(9;22)
Hypodiploidy
11q23-aberrations
TPMT-deficiency
Intolerance to MTX or 6MP
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: open label varenicline 2mg/day

Varenicline: Varenicline 1-2 mg/day
Eligibility criteria:
Inclusion Criteria:

Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
Recent History of Cigarette smoking
Ages 18-65
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 254
Group description: Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
Eligibility criteria:
Inclusion Criteria:

Male or Female 18 to 85 years of age
NDD-CKD Patients
TSAT </= 25%
Hgb </= 11.5
Ferritin </= 300
HD-CKD Patients
TSAT </= 30%
Hgb </= 12
Ferritin </= 500

Exclusion Criteria:

Previous participation in a FCM trial
Known Hypersensitivity to FCM
History of anemia other that anemia due to chronic renal failure
Current history of GI bleeding
Received IV Iron within the last 30 Days
Anticipated need for surgery
Malignancy history
AST or ALT greater than normal
Received an investigational drug within 30 days of screening
Pregnant or sexually active females who are not willing to use an effective form of birth control
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 996
Group description: Intravenous (IV) iron
Eligibility criteria:
Inclusion Criteria:

Female with iron deficiency anemia
Hg </= 11 g/dL

Exclusion Criteria:

Previous participation in a FCM trial
Known Hypersensitivity to FCM
History of anemia other that anemia due to heavy uterine bleeding or the post partum state
current history of GI bleeding
Received IV Iron within the month prior
Anticipated need for surgery
Malignancy history
AST or ALT greater than normal
Received an investigational drug within 30 days of screening
Pregnant or sexually active females who are not willing ot use an effective form of birth control
Intervention: Epinephrine
Trial phase: Not Applicable
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
Eligibility criteria:
Inclusion Criteria:

Patients ages 3-18 years
Patients undergoing device closure of an atrial septal defect in the cardiac catheterization lab
normal electrocardiogram without prolonged absolute or corrected QT interval(less than 440 msec)

Exclusion Criteria:

Patients with a history of any other structural or acquired heart disease besides the atrial septal defect.
Patient with a family history of sudden cardiac death, or personal history of syncope.
Patient on alpha or beta-blocking medications.
Pregnancy.
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
Eligibility criteria:
Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than schizophrenia)
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
Eligibility criteria:
Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than schizophrenia)
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Lurasidone 40 mg tablets taken once/day
Eligibility criteria:
Inclusion Criteria:

To be eligible to enter the study, each patient must comply with the following inclusion criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Any chronic organic disease of the CNS (other than schizophrenia)
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: INCB018424 15 mg BID
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of rheumatoid arthritis
Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion Criteria:

Patients who have taken the following drugs within the timeframe below:

Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
Rituximab - Within 12 months prior to the first dose of study medication;
Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: INCB018424 5 mg BID
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of rheumatoid arthritis
Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion Criteria:

Patients who have taken the following drugs within the timeframe below:

Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
Rituximab - Within 12 months prior to the first dose of study medication;
Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Intervention: Ruxolitinib
Trial phase: Phase 2
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: INCB018424 25 mg BID
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of rheumatoid arthritis
Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion Criteria:

Patients who have taken the following drugs within the timeframe below:

Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
Rituximab - Within 12 months prior to the first dose of study medication;
Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.