anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Metronidazole
Trial phase: Not Applicable
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.

Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days.
Eligibility criteria:
Inclusion Criteria:

referring doctor suspects peritonsillar abscess
patient is voluntary
patient has daily access to his/her e-mail
patient speaks and understands Finnish of Swedish
female patients have adequate birth-control method
patient has peritonsillar abscess

Exclusion Criteria:

allergy to penicillin
allergy to metronidazole
use of metronidazole in preceding one month
pregnancy
breast-feeding
renal insufficiency
liver insufficiency
alcoholism (drunk at least once a week)
participant in another clinical trial at the moment
treatment of peritonsillar abscess requires in-patient care
tonsillectomy during the next 30 days
army recruit
Intervention: Metronidazole
Trial phase: Not Applicable
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.

Penicillin and metronidazole in peritonsillar abscess: Peroral Penicillin: 1000 000 IU 3 times a day for 10 days; Peroral metronidazole: 500 mg 3 times a day for 7 days.
Eligibility criteria:
Inclusion Criteria:

referring doctor suspects peritonsillar abscess
patient is voluntary
patient has daily access to his/her e-mail
patient speaks and understands Finnish of Swedish
female patients have adequate birth-control method
patient has peritonsillar abscess

Exclusion Criteria:

allergy to penicillin
allergy to metronidazole
use of metronidazole in preceding one month
pregnancy
breast-feeding
renal insufficiency
liver insufficiency
alcoholism (drunk at least once a week)
participant in another clinical trial at the moment
treatment of peritonsillar abscess requires in-patient care
tonsillectomy during the next 30 days
army recruit
Intervention: Iobitridol
Trial phase: Phase 4
ATC code: V08AB11
SMILES: CN(CC(O)CO)C(=O)c1c(I)c(NC(=O)C(CO)CO)c(I)c(C(=O)N(C)CC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 152
Group description: Patients were IV injected with a single dose of iobitridol before a coronary CT angiography

iobitridol: single IV injection
Eligibility criteria:
Inclusion Criteria:

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
Patient with arrhythmia or non-sinus rhythm
Patient with decompensated heart failure
Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
Patient who has previously undergone coronary artery bypass graft
Patient who has previously undergone percutaneous transluminal coronary stent placement
Patient with artificial heart valve
Patient with known moderate to severe aortic stenosis
Intervention: Iomeprol
Trial phase: Phase 4
ATC code: V08AB10
SMILES: CN(C(=O)CO)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 152
Group description: Patients were IV injected with a single dose of iomeprol before a coronary CT angiography

iomeprol: Single IV injection
Eligibility criteria:
Inclusion Criteria:

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
Patient with arrhythmia or non-sinus rhythm
Patient with decompensated heart failure
Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
Patient who has previously undergone coronary artery bypass graft
Patient who has previously undergone percutaneous transluminal coronary stent placement
Patient with artificial heart valve
Patient with known moderate to severe aortic stenosis
Intervention: Co-Artemether
Trial phase: Phase 4
ATC code: P01BF01
SMILES: CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1C2=Cc1ccc(Cl)cc1.COC1OC2OC3(C)CCC4C(C)CCC(C1C)C24OO3
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4826
Group description: Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
Eligibility criteria:
Inclusion:

Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)

Exclusion:

Body weight <5 kg.
Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
Presence of severe malaria signs and symptoms
First trimester of pregnancy.
Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
Intervention: Co-Artemether
Trial phase: Phase 4
ATC code: P01BF01
SMILES: CCCCN(CCCC)CC(O)c1cc(Cl)cc2c1-c1ccc(Cl)cc1C2=Cc1ccc(Cl)cc1.COC1OC2OC3(C)CCC4C(C)CCC(C1C)C24OO3
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2275
Group description: Participants received COA566 treatment for symptomatic malaria episodes only.
Eligibility criteria:
Inclusion:

Subjects who were diagnosed as Asymptomatic Carrier (AC) by Rapid Diagnostic Test (RDT).
Subjects who were diagnosed with a Symptomatic malaria episode, RDT-confirmed (SMRC)

Exclusion:

Body weight <5 kg.
Hypersensitivity to artemether-lumefantrine or to any of the excipients of the tablets or dispersible tablets.
Presence of severe malaria signs and symptoms
First trimester of pregnancy.
Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease.
Taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole and triazole antifungal agents, certain non-sedating antihistamines.
Known disturbances of electrolyte balance, e.g. hypokalemia or hypomagnesemia.
Taking drugs which may be metabolized by cytochrome enzyme CYP2D6
Intervention: Basaglar
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Intensive glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.

Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Eligibility criteria:
Inclusion Criteria:

Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
Intervention: Basaglar
Trial phase: Not Applicable
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Conservative glycaemic control All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.

Insulin: All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
Eligibility criteria:
Inclusion Criteria:

Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
Intervention: Decapeptyl
Trial phase: Phase 2
SMILES: CC(C)CC(NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(N)=O.O=C(O)c1cc2ccccc2c(Cc2c(O)c(C(=O)O)cc3ccccc23)c1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
Karnofsky performance index > 70
Expected survival ≥ 9 months

Exclusion Criteria:

Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
Patient at risk of spinal cord compression or ureter obstruction
Prior hypophysectomy or adrenalectomy
Intervention: Decapeptyl
Trial phase: Phase 2
SMILES: CC(C)CC(NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(N)=O.O=C(O)c1cc2ccccc2c(Cc2c(O)c(C(=O)O)cc3ccccc23)c1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
Karnofsky performance index > 70
Expected survival ≥ 9 months

Exclusion Criteria:

Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
Patient at risk of spinal cord compression or ureter obstruction
Prior hypophysectomy or adrenalectomy
Intervention: Dextromethorphan
Trial phase: Phase 4
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 52
Group description: Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Eligibility criteria:
Inclusion Criteria:

Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:

Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
At least 5 coughs during the second 30-minute period of the 60-minute baseline period.

General good health, aside from a common cold, and has no contraindications to the study or rescue medication

Exclusion Criteria:

Acute, subchronic, or chronic cough due to any other condition other than a common cold

History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease
Intervention: Dorzolamide Hydrochloride
Trial phase: Not Applicable
SMILES: CCNC1CC(C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Dorzolamide 2%-timolol 0.5% topical eyedrops: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for pars plana vitrectomy with intraocular gas tamponade with sulfur hexafluoride (e.g., retinal detachment, macular hole, other condition at the discretion of the investigator).
Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

Prior trabeculectomy or tube shunt surgery.
Current use of topical aqueous suppressants or other glaucoma medications.
Aphakia or presence of anterior chamber intraocular lens implant.
Known allergy or contraindication to sulfa or beta-blocker use (e.g., asthma, chronic obstructive pulmonary disease, bradycardia).
Intervention: MK-2206
Trial phase: Phase 2
SMILES: NC1(c2ccc(-c3nc4ccn5c(=O)[nH]nc5c4cc3-c3ccccc3)cc2)CCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma may be included)
Relapsed or refractory after at least one regimen and with no curative option with conventional therapy
Bidimensionally measurable disease (at least 2 cm)
No evidence of cerebral or meningeal involvement by lymphoma
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Signed informed consent form prior to enrollment
Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a women become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately

Exclusion Criteria:

Burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia and cutaneous T-cell lymphoma
Chemotherapy or radiation therapy or other investigational agents within 3 weeks prior to entering the study unless there is clear evidence of progression of disease and toxicity from previous treatment has resolved in which case study entry may be within 1 week of last treatment
Previous radioimmunotherapy within 12 weeks
Patients with known immunodeficiency virus (HIV) infection must not have cluster of differentiation (CD)4 cells < 400/mm^3 and who must not have a prior acquired immunodeficiency syndrome (AIDS)-defining diagnosis and cannot be on antiretroviral therapy for HIV
Known active viral hepatitis
Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or with compliance with the study
Absolute neutrophil count < 1.5 x 10^9/L
Platelets < 75 x 10^9/L
Total bilirubin > 1.5 x upper limit of normal (ULN) (> 3 x ULN for patients with liver involvement)
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 2.5 x ULN (> 5 x ULN for patients with liver involvement)
Serum creatinine > 2 x ULN
Hemoglobin (Hb)A1C > 8%
Patients receiving any medications or substances that are inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP 450 3A4) are ineligible
Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
Cardiovascular: baseline Fredericia corrected QT interval (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
Significant heart block or baseline bradycardia < 50 beats per minute (bpm) due to cardiac disease
Patients who are pregnant or breastfeeding
Intervention: Buprenorphine
Trial phase: Phase 1
ATC code: N02AE01 | N07BC01 | N07BC51
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
Eligibility criteria:
Inclusion Criteria Include:

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Exclusion Criteria Include:

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).
A history of substance or alcohol abuse within the past 5 years.
Females who are nursing.
Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Other protocol-specific exclusion/inclusion criteria may apply.