anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: Dapagliflozin 10 mg, given once daily per oral use.
Eligibility criteria:
Inclusion Criteria:

Provision of signed informed consent prior to any study specific procedures
Male or female, aged ≥18 years
Documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 8 weeks
LVEF≤40%
Elevated NT-proBNP levels

Patients should receive background standard of care as described below: All HFrEF patients should be treated according to locally recognised guidelines on standard of care treatment with both drugs and devices, as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) before visit 1 and include (unless contraindicated or not tolerated):

an ACE inhibitor, or ARB or sacubitril/valsartan and
a beta-blocker and
if considered appropriate by the patient's treating physician; a mineral corticoid receptor antagonist
6MWD≥100 metres and ≤425 metres at enrolment and randomization.

Exclusion Criteria:

Presence of any condition that precludes exercise testing
Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial
Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus
eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation
Systolic BP <95 mmHg on 2 consecutive measurements
Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements
Current acute decompensated HF or hospitalisation due to decompensated HF <4 weeks prior to enrolment
MI, unstable angina, coronary revascularization ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
Stroke or transient ischemic attack within 12 weeks prior to enrolment.
Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease
Intervention: Levodopa
Trial phase: Phase 3
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 419
Group description: All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety.
Eligibility criteria:
Inclusion Criteria:

Successfully completed Study IPX203-B16-02
Able to provide written informed consent prior to the conduct of any study-specific procedures.
Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

Exclusion Criteria:

Intends to use any doses of Rytary® or Duopa™ during this study.
Plans to use an investigational treatment other than IPX203 during the course of this study.
Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
Participants who, in the opinion of the clinical investigator, should not participate in the study.
Intervention: NITROUS OXIDE
Trial phase: Phase 3
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Nitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

Nitrous Oxide: A total of three inhalation treatments with 50% Nitrous Oxide plus 50% oxygen (6 total exposure hours) over one week with 2 or 3 days between each session.
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with CRPS based on the revised International Association for the Study of Pain criteria.
Duration of disease must be at least 6 months.
Written informed consent.

Exclusion Criteria:

Patients who had no subjective benefit from ketamine infusions, as determined by interview during the recruitment process.
Patients taking more than 60mg of morphine equivalents or more daily for an alternative chronic pain condition.
Patients with both coronary artery disease (as determined by cardiac catheterization) and a functional status of less than 4 metabolic equivalents. The limited functional status must be secondary to cardiopulmonary symptoms (angina, dyspnea on exertion). Patients with coronary artery disease and a limited functional status (<4 METS) secondary to chronic pain can be included.
Patients with congestive heart failure of any etiology that are NYHA Class III or IV
Patients with moderate or severe pulmonary hypertension as determined by echocardiogram or right heart catheterization.
Patients with intraocular surgery within the past 14 days
Patients with worker's compensation claims and active litigation.
Patients who have been diagnosed with COPD.
Patients who use home oxygen therapy for any condition.
Diagnosis of Alcohol Use Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Illicit drug use within the past three months (not including marijuana).
Pregnant patients or patients with upcoming planned pregnancy.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 358
Group description: 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Eligibility criteria:
Inclusion Criteria:

Participants must:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
Be of stable weight (± 5%) for at least 3 months before screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

Participants must not:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 359
Group description: 15 mg tirzepatide administered SC once a week SC.
Eligibility criteria:
Inclusion Criteria:

Participants must:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
Be of stable weight (± 5%) for at least 3 months before screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

Participants must not:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Intervention: VALPROIC ACID
Trial phase: Phase 2
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 14
Group description: An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.

Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Eligibility criteria:
Inclusion Criteria:

acute migraine as per ICHD-II criteria
pediatric (age 10-18)

Exclusion Criteria:

For Valproic Acid (VPA)

Pregnancy
Liver disease (Acute or Chronic)
Urea Cycle Disorder
Mitochondrial Disease

For Dihydroergotamine (DHE)

Pregnancy
Peripheral vascular disease, coronary heart disease
History of cerebrovascular event
Severe or poorly controlled hypertension
Impaired liver or renal function
Triptan given in last 24 hours
Hemiplegic migraine
Intervention: Dihydroergotamine
Trial phase: Phase 2
ATC code: N02CA01 | N02CA51
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N[C@]1(C)O[C@]3(O)N(C1=O)[C@@H](Cc1ccccc1)C(=O)N1CCC[C@]13[H])CN2C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.

Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
Eligibility criteria:
Inclusion Criteria:

acute migraine as per ICHD-II criteria
pediatric (age 10-18)

Exclusion Criteria:

For Valproic Acid (VPA)

Pregnancy
Liver disease (Acute or Chronic)
Urea Cycle Disorder
Mitochondrial Disease

For Dihydroergotamine (DHE)

Pregnancy
Peripheral vascular disease, coronary heart disease
History of cerebrovascular event
Severe or poorly controlled hypertension
Impaired liver or renal function
Triptan given in last 24 hours
Hemiplegic migraine
Intervention: Elagolix
Trial phase: Phase 4
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Elagolix 150 mg QD
Eligibility criteria:
Inclusion Criteria:

Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].
Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.
Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.
Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Exclusion Criteria:

Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.
Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.
Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Intervention: Epinephrine
Trial phase: Phase 4
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Eligibility criteria:
Inclusion Criteria:

Patient age >18 years;
Lack of language barrier;
Informed consent obtained;
Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;
American Society of Anesthesiology (ASA) physical status score I- III

Exclusion Criteria:

Presence of a language barrier;
Inability to complete telephone and/or paper questionnaire;
Lack of consent;
Allergy to local anesthetic;
Chronic pain syndrome and/or preoperative opioid use > 50 MME per day (including extended-release formulations and methadone);
Preoperative consultation to chronic pain service;
History of (<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);
Baseline peripheral neuropathy of the brachial plexus;
Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;
Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;
Weight < 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;
Revision arthroplasty;
Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;
Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery
Intervention: Cilofexor
Trial phase: Phase 3
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 277
Group description: Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
Negative anti-mitochondrial antibody

Key Exclusion Criteria:

Current or prior history of any of the following:

Cirrhosis
Liver transplantation
Cholangiocarcinoma or hepatocellular carcinoma (HCC)
Ascending cholangitis within 30 days of screening
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Cilofexor
Trial phase: Phase 3
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Participants who received cilofexor in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
Negative anti-mitochondrial antibody

Key Exclusion Criteria:

Current or prior history of any of the following:

Cirrhosis
Liver transplantation
Cholangiocarcinoma or hepatocellular carcinoma (HCC)
Ascending cholangitis within 30 days of screening
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Cilofexor
Trial phase: Phase 3
SMILES: O=C(O)c1ccnc(N2CC(O)(c3ccc(OCc4c(-c5c(Cl)cccc5Cl)noc4C4CC4)cc3Cl)C2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Diagnosis of large duct PSC
Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

Platelet count ≥ 150,000/mm^3
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)
Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
Negative anti-mitochondrial antibody

Key Exclusion Criteria:

Current or prior history of any of the following:

Cirrhosis
Liver transplantation
Cholangiocarcinoma or hepatocellular carcinoma (HCC)
Ascending cholangitis within 30 days of screening
Presence of a percutaneous drain or biliary stent
Other causes of liver disease
Current or prior history of unstable cardiovascular disease
Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply