anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Eszopiclone: 3mg qpm for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female, age 18 through 64.
Meets ACR criteria for FMS, as determined by rheumatological examination and a medical history review.
Reports sleep maintenance insomnia (total sleep time of < 6.5 hours or sleep impairment consisting of 3 of 7 nights per week for a month by history) or sleep onset latency insomnia (at least 3 of 7 nights of sleep latency > 30 minutes), as well as clinically significant daytime distress or impairment during the 1 week self assessment prior to baseline.
Has completed 8th grade and is fluent in English.
If a female of child bearing potential, the patient must be non-pregnant and either post-menopausal or using an approved birth control method. Acceptable birth control methods include: history of tubal ligation, having a male partner who is sterile, IUDs, birth control pills or other hormonal birth control methods (e.g., birth control patch, Depo-Provera injections), and double-barrier methods (e.g., condom and foam).
Antidepressant medication will be allowed if the patient has been on a stable dose for at least one month.

Exclusion Criteria:

Evidence of traumatic injury, inflammatory rheumatic disease, or infectious or endocrine-related arthropathy.
Evidence of a primary sleep disorder (e.g., significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder, or REM sleep behavior disorder.
Any current, clinically significant medical condition.
Pregnancy.
Meets DSM-IV criteria for bipolar disorder, psychotic disorder, organic brain syndrome, or psychoactive substance abuse or dependence.
Any current psychiatric disorder that would interfere with study participation (investigator judgment).
Active suicidal ideation.
Plans to engage in additional psychotherapy during the study.
Concurrent use of benzodiazepines after 6pm or as a sleep aid.
Concurrent use of any other sleep aid.
Concurrent use of analgesics other than acetaminophen or non-steroidal anti-inflammatory medication.
Concurrent use of any medication that has not been stabilized for at least 1 month prior to screening.
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: 174
Group description: Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
Eligibility criteria:
Inclusion Criteria:

History of persistent bronchial asthma for at least 3 months prior to screening;
For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Exclusion Criteria:

Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
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: 175
Group description: Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
Eligibility criteria:
Inclusion Criteria:

History of persistent bronchial asthma for at least 3 months prior to screening;
For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Exclusion Criteria:

Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
Intervention: Pyrimethamine
Trial phase: Phase 2
ATC code: P01BD01 | P01BD51 | P01BF04 | P01BF09
SMILES: CCc1nc(N)nc(N)c1-c1ccc(Cl)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
Eligibility criteria:
Inclusion Criteria:

Well Controlled diabetic state
Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
Good glycaemic control

Exclusion Criteria:

Pregnant women and women at risk of conception
Patients taking digitalis glycosides
Patients with abnormal liver function tests
Patients with plasma creatinine great then 150 umol/l or unstable renal function
Poorly controlled Diabetes Mellitus
Uncontrolled infection
History of adverse reaction to herbal medicine
Unstable medical conditions
Non-compliance with regime
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.

Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg.
Eligibility criteria:
Inclusion Criteria:

Military veterans
Age between 18 and 55 years old
Reports of insomnia and nightmares
Current diagnosis of PTSD
Currently treated with an SSRI.
Medications and dosages will remain unchanged for the duration of the study
Participants will agree to remain in ongoing counseling services they may be receiving prior to study entry.
Able to read and write English
Provision of written informed consent

Exclusion Criteria:

Current, severe, untreated Major Depressive Disorder
Current history of suicidality requiring hospitalization
Current history (past 6 months) of substance or alcohol abuse
Currently actively psychotic or bipolar disorder (past year)
Resting blood pressure < 90/60 at the screening physical examination
Heart rate > 100 beats/minutes
Use of an alpha-1 antagonist agent or beta-blocker
Refusal to follow the safety measures
Unexpected, untreated, or serious EKG findings
Medications and/or dosage changed in the past two months
Unstable medical condition
Pregnant or breast-feeding women
Apnea-hypopnea index (AHI) > 15
Refusal to provide information relevant to selection criteria
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 1200 mg/daily of Gabapentin
Eligibility criteria:
Inclusion Criteria:

Males or females age 18-65 with cannabis dependence
Meets DSM-IV-TR criteria for Cannabis Dependence
Smoked marijuana at least once a week in the 90 days prior to study participation
Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
Significant medical disorders that will increase potential risk or interfere with study participation
Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
Treatment with an investigational drug in the last month
Intervention: Gadobutrol
Trial phase: Phase 3
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
Eligibility criteria:
Inclusion Criteria:

Chinese origin, with known or suspected brain or spine diseases

Exclusion Criteria:

Pregnancy
Lactation
Conditions interfering with MRI
Allergy to any contrast agent or any drugs
Participation in other trial
Require emergency treatment
Severely impaired liver and kidney functions
Intervention: Gadopentetate Dimeglumine
Trial phase: Phase 3
SMILES: CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO.O=C([O-])CN(CCN(CC(=O)[O-])CC(=O)O)CCN(CC(=O)[O-])CC(=O)O.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
Eligibility criteria:
Inclusion Criteria:

Chinese origin, with known or suspected brain or spine diseases

Exclusion Criteria:

Pregnancy
Lactation
Conditions interfering with MRI
Allergy to any contrast agent or any drugs
Participation in other trial
Require emergency treatment
Severely impaired liver and kidney functions
Intervention: Rosuvastatin
Trial phase: Phase 4
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: 10mg
Eligibility criteria:
Inclusion Criteria:

Presence of 3 or more of the following criteria;

Abdominal obesity (men >90cm women >80cm)
Triglycerides ≥ 150 mg/dL
HDL-C: men < 40 mg/dL, women < 50 mg/dL
BP ≥130/≥85 mmHg or anti-hypertensive treatment
Fasting blood glucose ≥100 mg dL or anti-diabetic treatment

Elevated LDL-C ;

≥130 mg/dL to < 220 mg/dL in lipid lowering agent naive subjects
≥100 mg/dL to < 200 mg/dL in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1.
Triglyceride < 500 mg/dL
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: 124
Group description: 10mg
Eligibility criteria:
Inclusion Criteria:

Presence of 3 or more of the following criteria;

Abdominal obesity (men >90cm women >80cm)
Triglycerides ≥ 150 mg/dL
HDL-C: men < 40 mg/dL, women < 50 mg/dL
BP ≥130/≥85 mmHg or anti-hypertensive treatment
Fasting blood glucose ≥100 mg dL or anti-diabetic treatment

Elevated LDL-C ;

≥130 mg/dL to < 220 mg/dL in lipid lowering agent naive subjects
≥100 mg/dL to < 200 mg/dL in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit 1.
Triglyceride < 500 mg/dL
Intervention: Meglumine gadobenate
Trial phase: Phase 4
ATC code: V08CA08
SMILES: CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO.O=C([O-])CN(CCN(CC(=O)[O-])CC(=O)[O-])CCN(CC(=O)[O-])C(COCc1ccccc1)C(=O)[O-].[Gd+3].[H+].[H+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Adverse events experienced by patients occurred relative to the administration of MultiHance.
Eligibility criteria:
Inclusion Criteria:

Was 18 years or older
Provided written informed consent
Scheduled for MRI
Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days

Exclusion Criteria:

Pregnant or lactating females
Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
Congestive heart failure, class IV
Previous stroke in the past year
Received another contrast agent within 24 hours pre and post each exam
Investigational product
Contraindications to MRI
Severe claustrophobia
Surgery with 3 weeks prior
Steroid therapy or radiosurgery between two exams
Intervention: Gadopentetate Dimeglumine
Trial phase: Phase 4
SMILES: CNCC(O)C(O)C(O)C(O)CO.CNCC(O)C(O)C(O)C(O)CO.O=C([O-])CN(CCN(CC(=O)[O-])CC(=O)O)CCN(CC(=O)[O-])CC(=O)O.[Gd+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Adverse events experienced by patients occurred relative to the administration of Magnevist.
Eligibility criteria:
Inclusion Criteria:

Was 18 years or older
Provided written informed consent
Scheduled for MRI
Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days

Exclusion Criteria:

Pregnant or lactating females
Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
Congestive heart failure, class IV
Previous stroke in the past year
Received another contrast agent within 24 hours pre and post each exam
Investigational product
Contraindications to MRI
Severe claustrophobia
Surgery with 3 weeks prior
Steroid therapy or radiosurgery between two exams
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
Eligibility criteria:
Inclusion Criteria:

Female subjects >/= 18 years of age
History of Heavy uterine bleeding
Hgb </= 11
Practicing acceptable birth control
Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

Known Hypersensitivity to oral or IV iron
Anemia other than iron deficiency anemia
Iron storage disorders
Initiation of treatment that may effect degree of heavy uterine bleeding
Anticipated need for surgery
Severe psychiatric disorder
Active infection
Positive Pregnancy test
Known Hep B or C or Active Hepatitis
Received investigational Drug within 30 days
Alcohol or drug abuse
Intervention: Ferrous Sulfate
Trial phase: Phase 3
ATC code: B03AA07
SMILES: O=S(=O)([O-])[O-].[Fe+2]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 178
Group description: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
Eligibility criteria:
Inclusion Criteria:

Female Subjects able to give consent
Post partum patients
Baseline Hbg< /= 10
Agree to practice birth control
Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria:

Known hypersensitivity reaction to oral or IV iron (VIT-45)
Documented history of discontinuing oral iron
Significant bleeding
History of anemia other that iron deficiency anemia
Severe Psychiatric disorders
Active severe infection
Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
Known HIV antibody
Received investigational product within 30 days
Alcohol abuse
Hemochromatosis or other iron storage disorder
Intervention: Divalproex Sodium
Trial phase: Phase 4
SMILES: CCCC(CCC)C(=O)O.CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Divalproex ER
Eligibility criteria:
Inclusion Criteria:

For inclusion, patients must fulfill all of the following criteria at enrollment:

Provide written informed consent before initiation of any study-related procedures
A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Mixed (296.5x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSMIV)
Male or female, at least 18 years old
YMRS score equal to or greater than 17 and a CGI of 4 (moderate) or greater.
Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.

Exclusion Criteria:

Known intolerance or lack of response to quetiapine fumarate or Divalproex ER as judged by the investigator.
Unwilling or not able to provide informed consent
Positive urine toxicology result on screening for cocaine, phencyclidine (PCP), opiates or amphetamines that confirms the current manic/mixed episode is better accounted by a substance intoxication or withdrawal as judged by PI.
History of schizophrenia or schizoaffective disorder
Treatment with a depot antipsychotic within 1 treatment cycle
Unstable medical condition including hepatic, renal, gastroenterologic, neurologic, immunologic, or hematologic diseases that is deemed by the principle investigator to likely to result in hospitalization in 6 months or death within one year
A female subject who is pregnant or lactating
Lorazepam will be provided for agitation and insomnia as needed for rescue only. Not to exceed 6 mg in the first 7 days; Not to exceed 4 mg for the next 3 days and note to exceed 2 mg/day for the remainder of the study. Those that require a greater amount of Lorazepam will be excluded.
Hospitalized for more than 1 week for current episode at the screen
Substance or alcohol dependence at enrollment and within the three months prior to enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
Known diagnosis of dementia or MCI
Intervention: Quetiapine
Trial phase: Phase 4
ATC code: N05AH04
SMILES: OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: quetiapine fumarate
Eligibility criteria:
Inclusion Criteria:

For inclusion, patients must fulfill all of the following criteria at enrollment:

Provide written informed consent before initiation of any study-related procedures
A diagnosis of Bipolar I Disorder, Most Recent Episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Mixed (296.5x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSMIV)
Male or female, at least 18 years old
YMRS score equal to or greater than 17 and a CGI of 4 (moderate) or greater.
Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive), double-barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.

Exclusion Criteria:

Known intolerance or lack of response to quetiapine fumarate or Divalproex ER as judged by the investigator.
Unwilling or not able to provide informed consent
Positive urine toxicology result on screening for cocaine, phencyclidine (PCP), opiates or amphetamines that confirms the current manic/mixed episode is better accounted by a substance intoxication or withdrawal as judged by PI.
History of schizophrenia or schizoaffective disorder
Treatment with a depot antipsychotic within 1 treatment cycle
Unstable medical condition including hepatic, renal, gastroenterologic, neurologic, immunologic, or hematologic diseases that is deemed by the principle investigator to likely to result in hospitalization in 6 months or death within one year
A female subject who is pregnant or lactating
Lorazepam will be provided for agitation and insomnia as needed for rescue only. Not to exceed 6 mg in the first 7 days; Not to exceed 4 mg for the next 3 days and note to exceed 2 mg/day for the remainder of the study. Those that require a greater amount of Lorazepam will be excluded.
Hospitalized for more than 1 week for current episode at the screen
Substance or alcohol dependence at enrollment and within the three months prior to enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
Known diagnosis of dementia or MCI
Intervention: Neratinib
Trial phase: Phase 1
ATC code: L01EH02
SMILES: CCOc1cc2ncc(C#N)c(Nc3ccc(OCc4ccccn4)c(Cl)c3)c2cc1NC(=O)/C=C/CN(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Neratinib 80 mg qd
Eligibility criteria:
Inclusion criteria

Diagnosis of metastatic or advanced cancer that has failed standard effective therapy
Life expectancy of at least 12 weeks and adequate performance status
Adequate bone marrow, kidney and liver function
Willingness of male and female subjects who are not surgically sterile or post-menopausal to use adequate methods of birth control

Exclusion Criteria

Any anticancer chemotherapy, radiotherapy immunotherapy or investigational agents within 4 weeks of first dose of HKI-272
Inadequate cardiac function
Surgery within 2 weeks of first dose of HKI-272
Active central nervous system metastases (i.e., symptomatic, required use of corticosteroids and/or progressive growth)
Significant gastrointestinal disorder with diarrhea as a major symptom
Pregnant or breast feeding women