Trial Outcomes & Findings for Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R (NCT NCT00534469)

Last Updated: 2025-12-02

Results Overview

Kaplan-Meier estimates at 2-years post-transplant, with 95% confidence intervals based on logit limit transformation of Greenwood's variance. Outcome is death or relapse, censor is alive in continual complete remission at the date of last clinical disease assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Estimate at 2 years post treatment

Results posted on

2025-12-02

Participant Flow

60 patients went on-study. 52 went on to autologous transplant. Seven completed consolidation therapy without moving on to transplant. One was given an allogeneic transplant.

Participant milestones

Participant milestones
Measure	HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. HD ARA-C with Idarubicin Consolidation, Busulfan/FTBI/VP16/PSC/BMT aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HD ARA-C With Idarubicin, or Without Idarubicin if Previously Treated With an Anthracycline. n=52 Participants HD ARA-C with Idarubicin Consolidation, Busulfan/FTBI/VP16/PSC/BMT aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation
Age, Categorical <=18 years	2 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Age, Continuous	42.3 years n=9 Participants
Sex: Female, Male Female	31 Participants n=9 Participants
Sex: Female, Male Male	21 Participants n=9 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian or Alaska Native, not of Hispanic Origin	1 Participants n=9 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian or Pacific Islander, not of Hispanic Origin	3 Participants n=9 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black, not of Hispanic Origin	2 Participants n=9 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	6 Participants n=9 Participants
Race/Ethnicity, Customized Race/Ethnicity · White, not of Hispanic Origin	40 Participants n=9 Participants
Region of Enrollment United States	52 participants n=9 Participants

PRIMARY outcome

Timeframe: Estimate at 2 years post treatment

Population: Transplanted patients

Outcome measures

Outcome measures
Measure	HD ARA-C Intermediate Cytogenetics n=52 Participants HD ARA-C Consolidation, Busulfan/FTBI/VP16/PSC/BMT +/- Idarubicin aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation bone marrow transplantation peripheral blood stem cell transplantation total-body irradiation	Intermediate Risk Cytogenetics Cytogenetic risk was estimated using criteria in effect in 1999.	Favorable Risk Cytogenetics Cytogenetic risk was estimated using criteria in effect in 1999.	Unknown Risk: Rejected Cytogenetics Study Cytogenetic risk was estimated using criteria in effect in 1999.
Disease-Free Survival at 2-Year Post-Transplant	0.65 Proportion of pts alive in remission Interval 0.52 to 0.77	—	—	—

SECONDARY outcome

Timeframe: Kaplan-Meier estimate 2 years post treatment

Outcome measures

Outcome measures
Measure	HD ARA-C Intermediate Cytogenetics n=3 Participants HD ARA-C Consolidation, Busulfan/FTBI/VP16/PSC/BMT +/- Idarubicin aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation bone marrow transplantation peripheral blood stem cell transplantation total-body irradiation	Intermediate Risk Cytogenetics n=20 Participants Cytogenetic risk was estimated using criteria in effect in 1999.	Favorable Risk Cytogenetics n=11 Participants Cytogenetic risk was estimated using criteria in effect in 1999.	Unknown Risk: Rejected Cytogenetics Study n=6 Participants Cytogenetic risk was estimated using criteria in effect in 1999.
Disease-Free Survival at 2-Year Post-Transplant by Cytogenetic Risk	0.33 Proportion of pts alive in remission Interval 0.04 to 0.85	0.75 Proportion of pts alive in remission Interval 0.52 to 0.89	0.75 Proportion of pts alive in remission Interval 0.44 to 0.92	0.73 Proportion of pts alive in remission Interval 0.41 to 0.91

Adverse Events

HD ARA-C With or Without Idarubicin

Serious events: 6 serious events

Other events: 47 other events

Deaths: 37 deaths

Serious adverse events

Serious adverse events
Measure	HD ARA-C With or Without Idarubicin n=60 participants at risk This study was designed as a single-arm study. Strata were: HD ARA-C w/ Idarubicin, CR\<6 months N = 24 patients. HD ARA-C w/ Idarubicin, CR\>6 months N=1. HD ARA-C consolidation, CR\<6 months N=5. HD ARA-C consolidation, CR\>6 months N= 0. aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation bone marrow transplantation peripheral blood stem cell transplantation total-body irradiation
Cardiac disorders Cardiac General - Other: CARDIOGENIC SHOCK	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: CONGESTIVE HEART FAILURE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac ischemia/infarction	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Myocarditis	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Febrile neutropenia (fever of unknown origin)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection, Bacterial (COH)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: PULMONARY HYPERTENSION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RESPIRATORY FAILURE DUE TO PULMONARY FIBROSIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: HEMORRHAGIC CYSTITIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.

Other adverse events

Other adverse events
Measure	HD ARA-C With or Without Idarubicin n=60 participants at risk This study was designed as a single-arm study. Strata were: HD ARA-C w/ Idarubicin, CR\<6 months N = 24 patients. HD ARA-C w/ Idarubicin, CR\>6 months N=1. HD ARA-C consolidation, CR\<6 months N=5. HD ARA-C consolidation, CR\>6 months N= 0. aldesleukin filgrastim busulfan cytarabine etoposide idarubicin autologous hematopoietic stem cell transplantation bone marrow transplantation peripheral blood stem cell transplantation total-body irradiation
Blood and lymphatic system disorders Bone marrow cellularity	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Hemoglobin	68.3% 41/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Leukocytes (total WBC) for BMT studies, if specified in the protocol.	76.7% 46/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Lymphopenia	58.3% 35/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.	75.0% 45/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Platelets	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Platelets for BMT studies, if specified in the protocol.	71.7% 43/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Transfusion: Platelets for BMT studies, if specified in the protocol.	71.7% 43/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Transfusion: pRBCs	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Transfusion: pRBCs for BMT studies, if specified in the protocol.	71.7% 43/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac Arrhythmia - Other:	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac Arrhythmia - Other: SOFT SYSTOLIC MURMUR GRADE 1/6	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Palpitations	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Prolonged QTc interval	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Supraventricular and nodal arrhythmia	45.0% 27/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Vasovagal episode	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: ASCITES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: CARDIOMEGALY	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: CHEST WALL SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: FACIAL EDEMA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: JUGULAR VENOUS DISTENSION INCREASED	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: PERIORBITAL EDEMA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac General - Other: RIGHT VENTRICULAR ENLARGEMENT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Cardiac troponin I (cTnI)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Hypertension	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Hypotension	41.7% 25/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Left ventricular systolic dysfunction	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Cardiac disorders Pericardial effusion (non-malignant)	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Edema	38.3% 23/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders INR (International Normalized Ratio of prothrombin time)	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Constitutional Symptoms - Other: CHILLS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Constitutional Symptoms - Other: FEVER (ABSENT NEUTROPENIA)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Constitutional Symptoms - Other: VAGINAL ITCHINESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Fatigue (asthenia, lethargy, malaise)	65.0% 39/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	48.3% 29/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Insomnia	40.0% 24/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Rigors/chills	50.0% 30/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Sweating (diaphoresis)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Weight gain	10.0% 6/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Weight loss	45.0% 27/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: ABRASIONS ON KNUCKLES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: BLISTERS ON THE TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: BURN ON THIGH (FROM A SOUP)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: BURNING FROM RADIATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: CRUST AT HICKMAN EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: DECUBITUS ULCER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: DERMATITIS FOCAL	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: DERMATITIS FOCAL (FINGER)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: DRY LIPS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: DRY SKIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: ERYTHEMA AT HICKMAN CATHETER EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: ERYTHEMA AT HICKMAN EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: ERYTHEMATOUS PALMS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: EYELID SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: FACIAL ERYTHEMA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: HANDS SKIN REACTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: HICKMAN SITE TENDERNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: HYPERPIGMENTED SKIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: IRRITATION AT HICKMAN EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: IRRITATION OF SKIN FROM HICKMAN CATHETER TAPE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: IRRITATION OF THE SKIN ALONG THE HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: LESION ON THE EYE CORNER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: LESION ON UPPER LIP (HERPES)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: LESIONS ON LIPS-HERPETIC	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: LICHENOID CHANGES OVER THE BUCCAL MUCOSA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: LT. KNEE CONTRACTURE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: NASAL CELLULITIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: PALE SKIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: PALLOR (PALE SKIN)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: PALMAR ERYTHEMA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: PEELING NAILS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: PRURITUS UPON PLATELETS TRANSFUSION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: RASH OVER THE GROIN AREA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: RAW RECTAL AREA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDDENED 2ND LT. TOE DUE TO OVERCLIPPING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDDENED RAC EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDNESS AT HICKMAN CATHETER EXIT SITE	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDNESS AT HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDNESS OF SKIN AT HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: REDNESS OF THE SKIN AT HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SCROTAL AREA EXCORIATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SCROTAL AREA PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SCROTAL EXCORIATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SHOULDER PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SKIN CHANGES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SKIN EXCORIATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SKIN INDURATION (PALMS)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SKIN LESION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SKIN LESIONS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SLIGHT SKIN EROSION DUE TO TAPE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SMALL CYST IN AXILLA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SWELLING AT CATHETER PORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: SWOLLEN RAC EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: TENDERNESS ON SOLES AND PALMS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: VAD SITE LEAKAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: VITILIGO	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: WARM AND RED SKIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: WARM SKIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other: YELLOWISH DRAINAGE FROM RAC EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Dry skin	38.3% 23/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Flushing	25.0% 15/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	20.0% 12/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	16.7% 10/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Nail changes	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	16.7% 10/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Pruritus/itching	36.7% 22/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Rash/dermatitis associated with high-dose chemotherapy or BMT studies.	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Rash/desquamation	23.3% 14/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Rash/desquamation associated with graft versus host disease (GVHD)	36.7% 22/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	20.0% 12/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Endocrine disorders Hot flashes/flushes	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Anorexia	66.7% 40/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Ascites (non-malignant)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Colitis	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Constipation	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Dehydration	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Diarrhea	31.7% 19/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Diarrhea associated with graft versus host disease (GVHD)	33.3% 20/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	21.7% 13/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Dysphagia-esophageal related to radiation	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Esophagitis	50.0% 30/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Flatulence	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ABD. BLOATING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ABDOMINAL BLOATING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ABDOMINAL DISTENTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: BLOATING	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: DECREASED GASTRIC EMPTYING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: DELAYED GASTRIC EMPTYING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: DIARRHEA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: DIARRHEA FOR BMT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: DRY HEAVES	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ESOPHAGITIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: FULLNESS IN RUQ	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: GAGGING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: GALL BLADDER SLUDGE (US)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: HEMORRHOID	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: HEPATOMEGALY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED MOUTH SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED MUCUS SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED ORAL MUCOUS SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED PHARYNGEAL SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED SALIVARY SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED SALIVATION	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INCREASED SECRETION OF MOUTH AND PHARYNX	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: INDIGESTION	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: IRRITATION ALONG THE SIDES OF TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: IRRITATION OF THROAT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ITCHINESS OF THROAT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: LEFT CHEECK SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: MUCOSITIS TONGUE	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: ORAL THRUSH	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: RETCHING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLIGHT BULGE OF ABDOMEN DUE TO VALSALVA MANEUVER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLIGHT HYPERTHROPHY OF TONGUE PAPILLAE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLIGHT YELLOW CLOUDING ON TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLOUGHING OF ORAL BUCCAL MUCOSA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLOUGHING OF THICK WHITE FILM FROM TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SLOUGHING OF TONGUE MUCOSA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SPLENOMEGALY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: STOMACH DISCOMFORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SUBMANDIBULAR AREA SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SUPERFICIAL ULCERATION OF BOTH TONSILS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: SWOLLEN TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: TENDERNESS OF LOWER ABDOMEN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: THIRSTY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: THROAT CONGESTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: TONGUE MUCOSITIS	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: UNABLE TO SWALLOW MOUTH SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: UNABLE TO SWALLOW SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Gastrointestinal - Other: VOMITING OF BLOODY MUCUS AND TISSUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Heartburn/dyspepsia	41.7% 25/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Nausea	71.7% 43/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Proctitis	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Salivary gland changes/saliva	25.0% 15/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	68.3% 41/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Taste alteration (dysgeusia)	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Gastrointestinal disorders Vomiting	70.0% 42/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hematemesis	20.0% 12/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hematuria (in the absence of vaginal bleeding)	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemoptysis	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	38.3% 23/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia	21.7% 13/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Melena/GI bleeding	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Rectal bleeding/hematochezia	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage, GU	21.7% 13/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage, pulmonary/upper respiratory	36.7% 22/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM DECUBITUS AREA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM MOUTH	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM PHARYNX	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM RAC SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM THE SKIN (SCATCH)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM THROAT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLEEDING FROM TONGUE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD FROM THE THROAT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD IN COUGH SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD IN SALIVA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD IN SPUTUM	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD TINGLED SALIVA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: BLOOD TINGLED SPUTUM	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: CONJUNCTIVAL RIGHT EYE HEMORRHAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: ECCHYMESIS LEFT AXILLA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: ECCHYMOSES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: ECCHYMOSIS AFTER HICKMAN CATHETER REMOVAL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: GUMS BLEEDING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: HICKMAN SITE BLEEDING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: MINIMAL BLEEDING UPON REMOVAL OF HICKMAN CATHETER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: MOUTH (GUM) BLEEDING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: MOUTH BLEEDING	10.0% 6/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: OOZING OF BLOOD FROM THROAT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: SCANT AMOUNT OF BLOOD AT HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: SCLERAL HEMORRHAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: SLIGHT BLEEDING FROM HICKMAN SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: SLIGHT OOZING FROM BMBX SITE AT PELVIS BONE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: SUBCONJUNCTIVAL HEMORRHAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Hemorrhage/Bleeding - Other: TONGUE BLEEDING	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Vascular disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	10.0% 6/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Hepatobiliary disorders Hepatobiliary/Pancreas - Other: 2 SOLID LESIONS IN LIVER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Hepatobiliary disorders Hepatobiliary/Pancreas - Other: HYPOPROTEINEMIA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Febrile neutropenia (fever of unknown origin)	56.7% 34/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: CONTACT ISOLATION DUE TO C. DIFFICILE INFECTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: SEPSIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: SPUTUM (MRSA)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: TOXIC SHOCK SYNDROME	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: UPPER RESPIRATORY INFECTION	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection - Other: UTI (MIXED)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection with unknown ANC	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection with grade 3 or 4 neutropenia	31.7% 19/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection without neutropenia	35.0% 21/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection, Bacterial (COH)	40.0% 24/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection, Fungal (COH)	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Infections and infestations Infection, Viral	28.3% 17/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Lymphatics - Other: SPLENOMEGALY (US)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	68.3% 41/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	60.0% 36/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Acidosis (metabolic or respiratory)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	75.0% 45/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Alkaline phosphatase	45.0% 27/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Alkalosis (metabolic or respiratory)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Bicarbonate, serum-low	23.3% 14/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	16.7% 10/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders CPK (creatine phosphokinase)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	73.3% 44/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Cholesterol, serum-high (hypercholesteremia)	31.7% 19/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Creatinine	23.3% 14/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	70.0% 42/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	18.3% 11/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	48.3% 29/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	45.0% 27/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	66.7% 40/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	11.7% 7/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	65.0% 39/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other: LOWER BACK PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other: SWOLLEN JOINTS OF HANDS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other: SWOLLEN LEFT ELBOW JOINT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other: SWOLLEN LEFT LEG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Ataxia (incoordination)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Confusion	15.0% 9/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Dizziness	33.3% 20/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Hallucinations	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Mood alteration	50.0% 30/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: ANXIETY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: DIURNAL VARIATION OF MOOD	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: DROWSINESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: FEAR	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: FEARFUL TO USE FENTANYL BOLUSES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: FLAT AFFECT ON PSYCHOSOCIAL ASSESSMENT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: FLAT EFFECT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: FRUSTRATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: IRRITABILITY (MOOD ALTERATION)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: LETHARGY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: NERVOUSNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: NIGHTMARES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: NUMBNESS	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: PANIC ATTACK	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: RUMINATIVE, OBSESSIVE AND FEARFUL MUCH OF THE TIME	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: SLEEPINESS	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: SOMNOLENCE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: TINGLING SENSATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: UNSTEADINESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: UNSTEADINESS BECAUSE OF VICODIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: VIBRATING SENSATION AT FEET WHILE WALKING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neurology - Other: VIBRATING SENSATION AT TORSO WHILE SITTING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neuropathy: cranial	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neuropathy: motor	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Neuropathy: sensory	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Somnolence/depressed level of consciousness	15.0% 9/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Syncope (fainting)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Nervous system disorders Tremor	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Dry eye syndrome	13.3% 8/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Nystagmus	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular surface disease	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: CONGESTED CONJUNCTIVAL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: CONJUNCTIVITIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: DILATATION OF PUPIL (LT. EYE)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: IRRITATION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: ITCHINESS OF EYES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: OD-VITREOUS OPACITY WITHOUT RETINAL DEFECT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: PERIORBITAL PUFFINESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: SLUGGISHNESS AND DILATATION OF RT. EYE PUPIL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: SWOLLEN EYES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ocular/Visual - Other: TRANSIENT SPOTS IN FRONT OF EYES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Ophthalmoplegia/diplopia (double vision)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Vision-blurred vision	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Vision-flashing lights/floaters	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Eye disorders Watery eye (epiphora, tearing)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain	66.7% 40/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other:	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: ABDOMINAL TENDERNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: ACHES AND STRAINS OF CHEST WALL MUSCLES BECAUSE OF COUGHING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: BACK PAIN	10.0% 6/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: BACK PAIN/BACK SPASM	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: BODY ACHES	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: BURNING BLOOD-SHOT PAIN EYES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: CATHETER PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: CHEST DISCOMFORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: CHEST PRESSURE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: CVA TENDERNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: DECUBITUS AREA PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: DIFFUSE ACHES AND PAINS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: DIFFUSE BUTTOCK AND SACRAL PAIN DUE TO DECUBITUS ULCER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: EPIGASTRIC PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: EPIGASTRIC PAIN WITH RADIATION TO BACK	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: ESOPHAGEAL DISCOMFORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: ESOPHAGEAL PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: GENERALIZED ACHES AND TENDERNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: GENERALIZED BODY ACHES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: HICKMAN CATHETER PAIN	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: KNEES PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LEFT ARM AND SHOULDER PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LEFT HAND PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LEFT LEG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LEG PAIN	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LEGS PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LOW BACK PAIN WHILE ON RUNNING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LOWER BACK PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LT. FLANK PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LT. KNEE PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LT. NECK SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: LT. SHOULDER PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: MOUTH PAIN	21.7% 13/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN AT BUTTOCKS DUE TO SHINGLES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN AT HANDS AND FEET	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN AT HICKMAN CATHETER EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN AT RAC EXIT SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN AT RUQ	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN DUE TO BP TAKING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN DUE TO LP PROCEDURE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN IN PALMS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAIN WHILE PASSING BLOOD CLOT IN FOLEY'S CATHETER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PALM PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: PAROTIDITIS (LT. SIDE)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: RAC SITE DISCOMFORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: RAC SITE PAIN	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: RIGHT ARM SORENESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: RIGHT FOREARM DISCOMFORT	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: RUQ TENDERNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: SCROTAL PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: SHOULDER PAIN	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: SINUS PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: SORE THROAT	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDER PALMS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDERNESS AT H. CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDERNESS AT HICKMAN CATHETER SITE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDERNESS AT RUQ	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDERNESS OVER LEFT CHEECK SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TENDERNESS OVER SINUSES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: THROAT PAIN	26.7% 16/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TOE AND FINGERTIP PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain - Other: TONGUE PAIN	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Pain ABDOMINAL CRAMPING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Cough	46.7% 28/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	18.3% 11/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	11.7% 7/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.7% 7/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	8.3% 5/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ASPIRATION PNEUMONIA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ATELECTASIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ATELECTASIS LLL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ATELECTASIS LT. MID LUNG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ATELECTASIS OF RLL WITH ELEVATED DIAPHRAGM	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BIBASILAR RALES	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BILATERAL DIFFUSE RALES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BILATERAL ELEVATION OF HEMIDIAPHRAGM	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BILATERAL RHONCHI	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BILATERAL SCATTERED CRACKLES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: BLUNTING OF LT. COSTOPHRENIC ANGLE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CHEST TIGHTNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CHRONIC SNEEZING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CLEAR SPUTUM PRODUCTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: COLD WITH NASAL DISCHARGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CRACKLES AT LLL LUNGS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CRACKLES AT LUNG BASES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: CRACKLES AT RLL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LT. LUNG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LUNG BASES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND RT. LUNG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: DECREASED BS AT RLL LUNG	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: DRY NOSE	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: ETHMOID SINUSITIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: EXPIRATORY WHEEZING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: MUCUS OBSTRUCTION OF ET TUBE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: MUCUS PLUG LLL	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: NASAL CONGESTION	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: NASAL DRAINAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: NASAL SECRETION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: NASAL STUFFINESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: OCCASIONAL RHONCHI	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: POST-NASAL DRAINAGE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: POST-NASAL DRIP	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: POSTNASAL DRIP	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: PULMONARY EDEMA	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: PULMONARY VASCULAR CONGESTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RALES RT. LUNG BASE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RHONCHI BOTH LUNGS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RHONCHI RT. LOWER LOBE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RLL ATELECTASIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RLL INFILTRATE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RUNNING NOSE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: RUNNY NOSE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: SINUS CONGESTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: SINUSITIS	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: SNEEZING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: STUFFY NOSE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: SUBSEGMENTAL ATELECTASIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: TACHYPNEA	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: UPPER AIRWAY CONGESTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: UPPER AIRWAY SWELLING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: WHEEZING	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other: WHEEZING AFTER BLOOD TRANSFUSION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	30.0% 18/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Bladder spasms	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Cystitis (COH)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Incontinence	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: BLOOD CLOT IN FOLEY'S CATHETER	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: BUN ELEVATED	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: DARK ORANGE COLOR URINE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: DIFFICULTY VOIDING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: GENITAL SORES	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: INCONTINENCE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: OBSTRUCTIVE UROPATHY	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Renal/Genitourinary - Other: PUL. OTHER/RHONCHI RT. LUNG BASE	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Renal and urinary disorders Urinary frequency/urgency	5.0% 3/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Reproductive system and breast disorders Libido	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.7% 4/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Immune system disorders Allergy/Immunology - Other: CHILLS AFTER I.V. AMPHOTERICIN INFUSION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Immune system disorders Allergy/Immunology - Other: NASAL CONGESTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Ear and labyrinth disorders Auditory/Ear - Other: DECREASED HEARING	3.3% 2/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Ear and labyrinth disorders Auditory/Ear - Other: DECREASED HEARING AT RT. EAR	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Ear and labyrinth disorders Auditory/Ear - Other: MILD SENSORY NERVE LOSS AT HEARING	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Ear and labyrinth disorders Auditory/Ear - Other: RT. TYMPANIC MEMBRANE DULLNESS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
General disorders Veno-Occlusive Disease (VOD)	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other:	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other: CHILLS UPON PRBC TRANSFUSION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other: ENGRAFTMENT SYNDROME	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other: INCREASED MCV	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other: SPHEROCYTOSIS	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.
Blood and lymphatic system disorders Blood/Bone Marrow - Other: TRANSFUSION REACTION	1.7% 1/60 • Adverse Events monitored/assessed up to 1 year post-transplant. All-Cause Mortality monitored/assessed up to 19 years post-transplant.

Additional Information

Dr. Anthony Stein

City of Hope Medical Center

Phone: 626-5375748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place