anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oxygen
Trial phase: Not Applicable
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients are their own controls and tested pre and post the addition of night time supplemental oxygen

Oxygen: Oxygen 2-3L Nasal cannula
Eligibility criteria:
Inclusion Criteria:

Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.
Clinical stability defined by absence of treatment change or need for acute care within the last two months.
Weight stable, within 5%, in the previous three months as measured during office visits.
Willingness to participate in a clinical study.

Exclusion Criteria:

Acute illness within the preceding 2 months.
Patients who received systemic glucocorticoid therapy within the past month.
Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.
Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas
Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.
No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.
Primary care or pulmonary physician refusal.
Patient refusal for any reason.
Lack of capacity to participate in the informed consent process.
Intervention: Relistor
Trial phase: Phase 2
ATC code: A06AH01
SMILES: C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: N-methylnaltrexone bromide (MOA-728): Oral
Eligibility criteria:
Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.
Intervention: Relistor
Trial phase: Phase 2
ATC code: A06AH01
SMILES: C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: N-methylnaltrexone bromide (MOA-728): Oral
Eligibility criteria:
Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.
Intervention: Relistor
Trial phase: Phase 2
ATC code: A06AH01
SMILES: C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: N-methylnaltrexone bromide (MOA-728): Oral
Eligibility criteria:
Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.
Intervention: Relistor
Trial phase: Phase 2
ATC code: A06AH01
SMILES: C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: N-methylnaltrexone bromide (MOA-728): Oral
Eligibility criteria:
Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
Eligibility criteria:
Inclusion Criteria:

Subjects 18 years or older with Prostate Cancer or Breast Cancer with Metastatic Bone Disease Have evidence of recurrence or disease progression
At least one radiographically confirmed metastatic bone lesion
No change of cancer therapy for at least 8 weeks before randomization

Exclusion Criteria:

Have had any prior exposure to bisphosphonate
Have had hip fractures or bilateral hip prothesis fracture of any kind or surgery to bone within the past 12 months
Inadequate renal function or low haemoglobin
Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate aminotransferase(AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 189
Group description: Precedex (Dexmedetomidine) 0.5/ug/kg/hr
Eligibility criteria:
Inclusion Criteria:

68 and older
elective major surgery under general anesthesia(major surgery is defined by a planned 2 day hospitalization)
ASA physical status I-III
capable and willing to consent
MMSE > 20 (to exclude dementia)

Exclusion Criteria:

Cardiac surgery
Intracranial Surgery
Emergency Surgery
Patients with severe visual or auditory disorder/handicaps
Illiteracy
Patients with clinically significant Parkinson's Disease
Patients not expected to be able to complete the 3 and 6 month postoperative tests
Sick sinus syndrome without pacemaker
Hypersensitivity to drug or class
Current 2nd or 3rd degree AV block
History of clinically significant bradycardia
Contraindication to the use of an 2A-agonist
Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
ASA physical status IV or V
Intervention: Fexofenadine hydrochloride and pseudoephedrine hydrochloride
Trial phase: Phase 2
SMILES: CC(C)(C(=O)O)c1ccc(C(O)CCCN2CCC(C(O)(c3ccccc3)c3ccccc3)CC2)cc1.CNC(C)C(O)c1ccccc1.Cl.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
Subjects that respond to a ragweed nasal allergen challenge at screening.

Exclusion Criteria:

History of asthma or FEV1 < 80% predicted.
Significant concomitant disease or medications.
Symptoms of allergic rhinitis within 2 weeks prior to screening.
Intervention: INSULIN DETEMIR
Trial phase: Not Applicable
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Subjects randomized to treatment with insulins detemir and aspart
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed type 1 diabetes within 1 week of diagnosis
Age 6 - 18 years
Care provided at Children's Medical Center, Dallas

Exclusion Criteria:

Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents)
Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids)
Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry)
Expected poor compliance
Pregnancy
Any other condition that by the judgement of the investigator may be potentially harmful to the patients
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 85
Group description: Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Sham Infants will not receive additional doses of Infasurf.
Eligibility criteria:
Inclusion Criteria:

Less than or equal to 1000 gm. birth weight
Less than or equal to 30 weeks gestational age
Day 7-14 of life
Intubated and mechanically ventilated at any time days 7-14 of life

Exclusion Criteria:

Serious congenital malformations
Life expectancy less than 7 days from enrollment
Previous treatment with iNO
Active pulmonary hemorrhage at time of enrollment
Active air leak syndrome at time of enrollment
Bilateral grade IV intracranial hemorrhage prior to enrollment
Less than 48 hours from last clinical dose of early surfactant.
Intervention: Bupropion Hydrochloride
Trial phase: Not Applicable
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: receiving bupropion SR

bupropion SR: 12 week course of bupropion SR 150 mg, BID
Eligibility criteria:
Inclusion Criteria:

patient in the substance use disorder program at either the Omaha VA Medical Center or at Catholic Charities Campus for Hope
diagnosis of methamphetamine dependence as well as presence or history of psychosis based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria (not to include patients in full sustained remission)
provide names, addresses, and phone numbers of at least two collateral informants who can provide information on their methamphetamine and other drug use during follow-up
must sign an informed consent as approved by the UNMC Internal Review Board (IRB) and Catholic Charities Research Committee.

Exclusion Criteria:

a history of severe injury to their brain
advanced cardiac, pulmonary, renal or liver disease
predisposition to seizures
history of bulimia or anorexia nervosa
current diagnosis of major depressive disorder
diagnosis or past history of panic disorders, schizophrenia, or bipolar affective disorder
family history or childhood history of epilepsy or seizures
history of strokes, brain tumors, or bleeding in the brain.
used any psychoactive drug within one week of study entry (two weeks for MAO (monoamine oxidase) inhibitors or protriptyline, four weeks for fluoxetine)
currently using any theophylline product (e.g. Theodur)
used an investigational drug in any study within the past four weeks
used a therapeutic course of bupropion SR for > 1 week at any time in the past 12 months or have been evaluated in previous studies examining bupropion SR at anytime
If female, the participant must not be pregnant or breast feeding
Intervention: Dexmedetomidine
Trial phase: Phase 1
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 56
Group description: Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.

Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion
Eligibility criteria:
Inclusion Criteria:

Patients must be greater or equal to one month or less than or equal to 24 months of age.
Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
Planned tracheal extubation within 24 hours post-operatively.
Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and >12 months to 24 months creatinine < or= to 1.0mg/dL)
Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to 165 U/L and > 12 months to 24 months < or = to 90 U/L)
Isolated heart surgery
Informed consent

Exclusion Criteria:

Patients who have received another investigational drug within the past 30 days.
Receiving continuous infusions of muscle relaxants in the postoperative setting.
Patients whoo have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
Patients, who, int he opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Patients who show signs or symptoms of elevated intracranial pressure.
Post-operative hypotension based on age.
Preexisting bradycardia based on age.
Heart block
Weight < 5kg
Patients, who in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 4
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Enteric-coated Mycophenolate Sodium (Myfortic)

1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months
Eligibility criteria:
Inclusion Criteria:

Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
Patients who are able to give written informed consent.

Exclusion Criteria:

Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
Known sensitivity to the study drug or class of the study drug.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Use of any other investigational agent in the last 30 days.
Intervention: Dexmedetomidine
Trial phase: Phase 1
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 30
Group description: Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.

Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
Eligibility criteria:
Inclusion Criteria:

Patients must be less than or equal to 1 month old.
Postconceptual age must be > or equal to 37 weeks on the day of surgery.
Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
Planned tracheal extubation within 24 hrs post-op.
Adequate renal function (serum creatine < or equal to 1.5mg/dL)
Adequate liver function (ALT < or equal to 165 U/L)
Isolated heart surgery
Informed consent

Exclusion Criteria:

Patients who have received another investigational drug since birth.
Patients receiving continuous infusions of muscle relaxants in the post-op setting.
Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
Patients who show signs and symptoms of elevated intracranial pressure.
Post-op hypotension defined by post conceptual age.
Pre-existing bradycardia defined by age
Heart block
Weight < 2kg
Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: This was a nonintervention biomarker study after a single dose of Zoledronic acid.
Eligibility criteria:
Inclusion Criteria:

Men or women 18 years of age or older
Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months
MM patients in either CR (complete response) or PR (partial response) by EBMT criteria
ECOG Performance Status of 0-2

Exclusion Criteria:

MM patients on active anti-MM therapy (maintenance regimens allowed)
Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min
Relapsed, refractory or progressive disease
Any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study
Hypersensitivity or any contraindication to a single dose of zoledronic acid
Intervention: Ergocalciferol
Trial phase: Phase 4
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Eligibility criteria:
Inclusion Criteria:

women at least five years past onset of menopause, defined as date of last menses (ages reported above are the range in ages of the participants recruited to the study)
serum 25(OH)D 16-24 ng/ml by reverse phase HPLC
calcium intake < or = 1,100 mg daily

Exclusion Criteria:

Intake of >1,100 mg of calcium per day through the combination of diet and supplements
Hypercalcemia (baseline serum calcium above the normal reference range)
Nephrolithiasis, documented in the medical record or by patient report
Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics within the past month
Creatinine >2.0 mg/dL
Hypercalciuria (baseline urine calcium: creatinine ratio >0.25)
Current use of medications known to interfere with vitamin D and/or calcium metabolism, including oral steroids or anticonvulsants
Ongoing or recent (past six months) use of bisphosphonates, estrogen compounds, calcitonin or teriparatide, as these compounds may independently affect retention of calcium within bone
Diagnosis of, or evidence for, osteomalacia, manifest by serum 25(OH)D < 16 ng/ml or the presence of at least two of the following blood tests: low calcium, low phosphorus, or elevated alkaline phosphatase (23).
Prior adult clinical fragility fracture or baseline T-score below -3.0 at the lumbar spine or femur
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 4
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Mycophenolate sodium taken with a meal
Eligibility criteria:
Inclusion Criteria:

Renal transplant recipients greater than 18 years of age, who have given written consent

Exclusion Criteria:

Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium
Experienced an acute rejection episode prior to the pharmacokinetic profile collection
Serum creatinine >2 mg/dL
Neutropenia (Absolute Neutrophil Count < 1.3x10^3/mL)
Received a previous transplant other than a kidney
Receiving chronic steroids at time of transplant
Known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid or any of its excipients
Intervention: MYCOPHENOLIC ACID
Trial phase: Phase 4
ATC code: L04AA06
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)O)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Mycophenolate sodium taken separately from food by 2 hours
Eligibility criteria:
Inclusion Criteria:

Renal transplant recipients greater than 18 years of age, who have given written consent

Exclusion Criteria:

Taking medications that may alter the metabolism of tacrolimus or mycophenolate sodium
Experienced an acute rejection episode prior to the pharmacokinetic profile collection
Serum creatinine >2 mg/dL
Neutropenia (Absolute Neutrophil Count < 1.3x10^3/mL)
Received a previous transplant other than a kidney
Receiving chronic steroids at time of transplant
Known hypersensitivity to tacrolimus, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid or any of its excipients