anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 59
Group description: Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria which must be verified at the end of first 18-months treatment (Visit 9)

Having completed the previous 18-month treatment period of the EPAAC trial - NCT00152464

Exclusion Criteria:

None
Intervention: Brivaracetam
Trial phase: Phase 2
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Brivaracetam 200 mg/day (100 mg administered twice a day).
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria:

Male/female subject aged 18 years or older.
Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.
Subject being treated with Carbamazepine for any indication.
Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.

Exclusion Criteria:
Intervention: Brivaracetam
Trial phase: Phase 2
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Brivaracetam 400 mg/day (200 mg administered twice a day).
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria:

Male/female subject aged 18 years or older.
Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.

Exclusion Criteria:

Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.
Subject being treated with Carbamazepine for any indication.
Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.

Exclusion Criteria:
Intervention: Cetirizine
Trial phase: Phase 4
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 5 mg of Levocetirizine (LCTZ) was taken orally once a day.
Eligibility criteria:
Inclusion Criteria:

Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years.
Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year).
Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

Exclusion Criteria:

Subjects currently treated by specific parietaria pollen immunotherapy
Subjects suffering from non-allergic asthma
Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
Intervention: Cetirizine
Trial phase: Phase 4
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: 5 mg of Levocetirizine (LCTZ) was taken whenever needed.
Eligibility criteria:
Inclusion Criteria:

Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years.
Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year).
Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

Exclusion Criteria:

Subjects currently treated by specific parietaria pollen immunotherapy
Subjects suffering from non-allergic asthma
Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
Eligibility criteria:
Inclusion Criteria:

No age limit
probable/possible Alzheimer's disease diagnosis
disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
no hypotension
no concurrent use of alpha-1-blockers
no delirium, schizophrenia, mania, psychotic symptoms.

Exclusion Criteria:

Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
Current enrollment in a separate investigational drug trial
Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change (CGIC) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
Intervention: Ciclesonide
Trial phase: Phase 3
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 79
Group description: Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Eligibility criteria:
Main Inclusion Criteria:

Outpatients
Symptoms consistent with the diagnosis of asthma for at least 12 months
Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
Participants who have a history of reversible airway obstruction
Good health with the exception of asthma

Main Exclusion Criteria:

History of life-threatening asthma
A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
Prematurely born children (<36 weeks of gestation)
Smokers
Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
Intervention: Ciclesonide
Trial phase: Phase 3
ATC code: R01AD13 | R03BA08
SMILES: [H][C@@]12C[C@@]3([H])O[C@@H](C4CCCCC4)O[C@@]3(C(=O)COC(=O)C(C)C)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 76
Group description: Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
Eligibility criteria:
Main Inclusion Criteria:

Outpatients
Symptoms consistent with the diagnosis of asthma for at least 12 months
Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
Participants who have a history of reversible airway obstruction
Good health with the exception of asthma

Main Exclusion Criteria:

History of life-threatening asthma
A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
Prematurely born children (<36 weeks of gestation)
Smokers
Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
Eligibility criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Individuals who are suicidal, psychotic, or with bipolar depression
alcohol or substance abuse or
regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
have narrow-angle glaucoma, liver disease,
severe allergies (especially to antidepressants similar to escitalopram or desipramine)
seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.
Intervention: Desipramine
Trial phase: Phase 4
ATC code: N06AA01
SMILES: CNCCCN1c2ccccc2CCc2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
Eligibility criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Individuals who are suicidal, psychotic, or with bipolar depression
alcohol or substance abuse or
regularly use medications which alter mood or blood vessel function (zolpidem or zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline, central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines, or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase inhibitors (MAOIs),
have narrow-angle glaucoma, liver disease,
severe allergies (especially to antidepressants similar to escitalopram or desipramine)
seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is untreated.
Depressed patients with a prior history of severe adverse events associated with SSRIs or TCAs will not be accepted into the study.
Intervention: Vytorin
Trial phase: Phase 4
ATC code: C10BA02
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21.O=C1C(CCC(O)c2ccc(F)cc2)C(c2ccc(O)cc2)N1c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 203
Group description: Ezetimibe 10 mg/Simvastatin 20 mg
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of hypercholesterolemia
LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Exclusion Criteria:

Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 203
Group description: Atorvastatin 10 mg
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of hypercholesterolemia
LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Exclusion Criteria:

Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
Intervention: Icosapent
Trial phase: Phase 2
SMILES: CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.

Eicosapentaenoic acid (omega-3 fatty acid): 2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Eligibility criteria:
Inclusion Criteria:

Patients meeting Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for schizophrenia (or schizoaffective disorder), major depression, or bipolar (depressed phase) disorder who are treated with antipsychotic, antidepressant or antimanic drugs and a lipid-lowering drug (statin) for 2 months or longer will be screened to participate in the proposed project.

Based upon the CAD risk determinants (see below) and the National Cholesterol Education Program (NCEP) recommendation of goals for LDL-lowering therapy, the investigators will only enroll schizophrenic patients with baseline (before statin treatment) LDL-cholesterol exceeding:

70 mg/dL having CAD and CAD risk equivalents, e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, and diabetes, as well as multiple risk factors that confer a 10-year risk for CAD > 20%
130 mg/dL having 2 or more risk factors; and
160 mg/dL having less than 2 risk factors to participate in the EPA trial.

In addition, these CAD-risk patients have not reached the NCEP goal level within the past year following statin treatment.

Risk factors for CAD. The NCEP Expert Panel (NIH Publication No. 01-3670, May 2001) on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III or ATPIII) recognizes the following CAD risk factors:

being male, 45 years or older, or being female 55 years or older;
family history of premature CAD;
current cigarette smoking;
hypertension with 140/90 mmHg or greater; and
low HDL-cholesterol (less than 40 mg/dL).

Exclusion Criteria:

Patients with history of bleeding disorders, current drug or alcohol abuse (within one month), neurological disorders (including head injury with loss of consciousness for greater than 10 minutes), antisocial personality disorder, borderline personality disorder, or mental retardation as indicated in medical records
Patients who are pregnant (as determined by urine pregnancy test)
Patients who have already achieved their NCEP goal in terms of their lipid profile (as indicated in laboratory tests) will be excluded.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 160
Group description: 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Eligibility criteria:
Key Inclusion Criteria:

18 years of age or older with diabetic macular edema;
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

Known anticipated need for ocular surgery within first 12 months of study;
History of glaucoma or current high eye pressure requiring more than 1 medication;
Uncontrolled systemic disease;
Known steroid-responder;
Use of systemic steroids
Use of Warfarin/Heparin
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Eligibility criteria:
Key Inclusion Criteria:

18 years of age or older with diabetic macular edema;
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

Known anticipated need for ocular surgery within first 12 months of study;
History of glaucoma or current high eye pressure requiring more than 1 medication;
Uncontrolled systemic disease;
Known steroid-responder;
Use of systemic steroids
Use of Warfarin/Heparin
Intervention: Topotecan
Trial phase: Phase 1 | Phase 2
ATC code: L01CE01 | L01XX17
SMILES: CC[C@@]1(O)C(=O)OCc2c1cc1n(c2=O)Cc2cc3c(CN(C)C)c(O)ccc3nc2-1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Topotecan 1mg/m2/d on day 1-3, q 21d
Eligibility criteria:
Inclusion Criteria:

Age >= 18 years
patient with ovarian cancer after primary therapy
bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
ECOG <= 2
Intention of regular follow-up visits for the duration of the study
written informed consent

Exclusion Criteria:

any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
ECOG > 2
patients with radiotherapy within the last 4 weeks
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 260
Group description: Participants initially received STI571 capsules or tablets, orally, initially once daily (400 mg) or (600 mg). The dosage was escalated from 400 mg to 600 mg and from 600 mg to 800 mg, on an individual basis as per the investigator's judgement. Treatment continued until death, or the development of intolerable toxicity, or the participant was considered not to benefit from treatment, whichever came first.
Eligibility criteria:
Inclusion Criteria:

1. Participants with Philadelphia chromosome positive chronic myelogenous leukemia (CML) in myeloid blast crisis (including both newly diagnosed and the participants who received prior therapy for accelerated or blastic phases), defined as either:

≥ 30% blast in peripheral blood and /or bone marrow
by flow cytometry criteria

2. To be categorized as "newly diagnosed", participants with CML in blast crisis were not to have received specific therapy for CML accelerated or blast phases, with the exception of interferon-alpha or hydroxyurea.

3. serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) not more than 3 times the upper limit of the normal range (ULN) (or not more than 5 times the ULN if clinically suspected leukemic involvement of the liver), serum creatinine concentration not more than 2 times the ULN, and total serum bilirubin level not more than 3 times the ULN at the laboratory where the analyses were performed.

4. A negative pregnancy test in participants of childbearing potential.

Exclusion Criteria:

Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3.
Participants previously treated for blast crisis were not to have received any of the following with respect to Day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.
Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1.
Participants receiving any other investigational agents within 28 days of Day 1.
Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions.

Other protocol-defined inclusion/exclusion criteria may apply.