Study: NCT00534469

Adverse event: Cardiac General - Other: CARDIOGENIC SHOCK
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: CONGESTIVE HEART FAILURE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection, Bacterial (COH)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: PULMONARY HYPERTENSION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RESPIRATORY FAILURE DUE TO PULMONARY FIBROSIS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: HEMORRHAGIC CYSTITIS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Allergy/Immunology - Other: CHILLS AFTER I.V. AMPHOTERICIN INFUSION
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Allergy/Immunology - Other: NASAL CONGESTION
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Auditory/Ear - Other: DECREASED HEARING
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 60 at risk

Adverse event: Auditory/Ear - Other: DECREASED HEARING AT RT. EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 60 at risk

Adverse event: Auditory/Ear - Other: MILD SENSORY NERVE LOSS AT HEARING
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 60 at risk

Adverse event: Auditory/Ear - Other: RT. TYMPANIC MEMBRANE DULLNESS
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 60 at risk

Adverse event: Veno-Occlusive Disease (VOD)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other:
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other: CHILLS UPON PRBC TRANSFUSION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other: ENGRAFTMENT SYNDROME
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other: INCREASED MCV
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other: SPHEROCYTOSIS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood/Bone Marrow - Other: TRANSFUSION REACTION
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Bone marrow cellularity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 60 at risk

Adverse event: Leukocytes (total WBC) for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 60 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 35 affected / 60 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 60 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Platelets for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 60 at risk

Adverse event: Transfusion: Platelets for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 60 at risk

Adverse event: Transfusion: pRBCs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Transfusion: pRBCs for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 60 at risk

Adverse event: Cardiac Arrhythmia - Other:
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac Arrhythmia - Other: SOFT SYSTOLIC MURMUR GRADE 1/6
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Prolonged QTc interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 60 at risk

Adverse event: Vasovagal episode
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: ASCITES
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: CARDIOMEGALY
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cardiac General - Other: CHEST WALL SWELLING
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: FACIAL EDEMA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: JUGULAR VENOUS DISTENSION INCREASED
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: PERIORBITAL EDEMA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac General - Other: RIGHT VENTRICULAR ENLARGEMENT
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac troponin I (cTnI)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 60 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 60 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 60 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 60 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 60 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Constitutional Symptoms - Other: CHILLS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Constitutional Symptoms - Other: FEVER (ABSENT NEUTROPENIA)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Constitutional Symptoms - Other: VAGINAL ITCHINESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 39 affected / 60 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 29 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 60 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 60 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 27 affected / 60 at risk

Adverse event: Bruising (in absence of Grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: ABRASIONS ON KNUCKLES
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: BLISTERS ON THE TONGUE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: BURN ON THIGH (FROM A SOUP)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: BURNING FROM RADIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: CRUST AT HICKMAN EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: DECUBITUS ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: DERMATITIS FOCAL
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: DERMATITIS FOCAL (FINGER)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: DRY LIPS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: DRY SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: ERYTHEMA AT HICKMAN CATHETER EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: ERYTHEMA AT HICKMAN EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: ERYTHEMATOUS PALMS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: EYELID SWELLING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: FACIAL ERYTHEMA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: HANDS SKIN REACTION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: HICKMAN SITE TENDERNESS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: HYPERPIGMENTED SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: IRRITATION AT HICKMAN EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: IRRITATION OF SKIN FROM HICKMAN CATHETER TAPE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: IRRITATION OF THE SKIN ALONG THE HICKMAN CATHETER SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: LESION ON THE EYE CORNER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: LESION ON UPPER LIP (HERPES)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: LESIONS ON LIPS-HERPETIC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: LICHENOID CHANGES OVER THE BUCCAL MUCOSA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: LT. KNEE CONTRACTURE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: NASAL CELLULITIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: PALE SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: PALLOR (PALE SKIN)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: PALMAR ERYTHEMA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: PEELING NAILS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: PRURITUS UPON PLATELETS TRANSFUSION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: RASH OVER THE GROIN AREA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: RAW RECTAL AREA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDDENED 2ND LT. TOE DUE TO OVERCLIPPING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDDENED RAC EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDNESS AT HICKMAN CATHETER EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDNESS AT HICKMAN CATHETER SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDNESS OF SKIN AT HICKMAN CATHETER SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: REDNESS OF THE SKIN AT HICKMAN CATHETER SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SCROTAL AREA EXCORIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SCROTAL AREA PAIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SCROTAL EXCORIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SHOULDER PAIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SKIN CHANGES
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SKIN EXCORIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SKIN INDURATION (PALMS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SKIN LESION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SKIN LESIONS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SLIGHT SKIN EROSION DUE TO TAPE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SMALL CYST IN AXILLA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SWELLING AT CATHETER PORT
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: SWOLLEN RAC EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: TENDERNESS ON SOLES AND PALMS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: VAD SITE LEAKAGE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: VITILIGO
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: WARM AND RED SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: WARM SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dermatology/Skin - Other: YELLOWISH DRAINAGE FROM RAC EXIT SITE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 60 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 60 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 60 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 60 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pigmentation changes (e.g., vitiligo)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 60 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 60 at risk

Adverse event: Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 60 at risk

Adverse event: Rash/desquamation associated with graft versus host disease (GVHD)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 60 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 60 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 60 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 60 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 60 at risk

Adverse event: Diarrhea associated with graft versus host disease (GVHD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 60 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 60 at risk

Adverse event: Dysphagia-esophageal related to radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 60 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ABD. BLOATING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL BLOATING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL DISTENTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: BLOATING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: DECREASED GASTRIC EMPTYING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: DELAYED GASTRIC EMPTYING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: DIARRHEA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: DIARRHEA FOR BMT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: DRY HEAVES
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ESOPHAGITIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: FULLNESS IN RUQ
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: GAGGING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: GALL BLADDER SLUDGE (US)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: HEMORRHOID
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: HEPATOMEGALY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED MOUTH SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED MUCUS SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED ORAL MUCOUS SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED PHARYNGEAL SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED SALIVARY SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED SALIVATION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INCREASED SECRETION OF MOUTH AND PHARYNX
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: INDIGESTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: IRRITATION ALONG THE SIDES OF TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: IRRITATION OF THROAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ITCHINESS OF THROAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: LEFT CHEECK SWELLING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: MUCOSITIS TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Gastrointestinal - Other: ORAL THRUSH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: RETCHING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLIGHT BULGE OF ABDOMEN DUE TO VALSALVA MANEUVER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLIGHT HYPERTHROPHY OF TONGUE PAPILLAE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLIGHT YELLOW CLOUDING ON TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLOUGHING OF ORAL BUCCAL MUCOSA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLOUGHING OF THICK WHITE FILM FROM TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SLOUGHING OF TONGUE MUCOSA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SPLENOMEGALY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: STOMACH DISCOMFORT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SUBMANDIBULAR AREA SWELLING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SUPERFICIAL ULCERATION OF BOTH TONSILS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: SWOLLEN TONGUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: TENDERNESS OF LOWER ABDOMEN
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: THIRSTY
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: THROAT CONGESTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: TONGUE MUCOSITIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Gastrointestinal - Other: UNABLE TO SWALLOW MOUTH SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: UNABLE TO SWALLOW SECRETION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Gastrointestinal - Other: VOMITING OF BLOODY MUCUS AND TISSUE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 60 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 60 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 60 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 60 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 60 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 60 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 60 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 60 at risk

Adverse event: Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 60 at risk

Adverse event: Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 60 at risk

Adverse event: Melena/GI bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 60 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 60 at risk

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 60 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM DECUBITUS AREA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM HICKMAN CATHETER SITE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM MOUTH
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM PHARYNX
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM RAC SITE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM THE SKIN (SCATCH)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM THROAT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM TONGUE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD FROM THE THROAT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD IN COUGH SECRETION
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD IN SALIVA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD IN SPUTUM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD TINGLED SALIVA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD TINGLED SPUTUM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: CATHETER SITE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: CONJUNCTIVAL RIGHT EYE HEMORRHAGE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: ECCHYMESIS LEFT AXILLA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: ECCHYMOSES
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: ECCHYMOSIS AFTER HICKMAN CATHETER REMOVAL
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: GUMS BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: HICKMAN SITE BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: MINIMAL BLEEDING UPON REMOVAL OF HICKMAN CATHETER
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: MOUTH (GUM) BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: MOUTH BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: OOZING OF BLOOD FROM THROAT
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: SCANT AMOUNT OF BLOOD AT HICKMAN CATHETER SITE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: SCLERAL HEMORRHAGE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: SLIGHT BLEEDING FROM HICKMAN SITE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: SLIGHT OOZING FROM BMBX SITE AT PELVIS BONE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: SUBCONJUNCTIVAL HEMORRHAGE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hemorrhage/Bleeding - Other: TONGUE BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 60 at risk

Adverse event: Hepatobiliary/Pancreas - Other: 2 SOLID LESIONS IN LIVER
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hepatobiliary/Pancreas - Other: HYPOPROTEINEMIA
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 60 at risk

Adverse event: Infection - Other: CONTACT ISOLATION DUE TO C. DIFFICILE INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection - Other: SEPSIS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection - Other: SPUTUM (MRSA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection - Other: TOXIC SHOCK SYNDROME
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection - Other: UPPER RESPIRATORY INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 60 at risk

Adverse event: Infection - Other: UTI (MIXED)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 60 at risk

Adverse event: Infection with grade 3 or 4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 60 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 60 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 60 at risk

Adverse event: Infection, Bacterial (COH)
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 60 at risk

Adverse event: Infection, Fungal (COH)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 60 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 60 at risk

Adverse event: Lymphatics - Other: SPLENOMEGALY (US)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 60 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 60 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 45 affected / 60 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 60 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 60 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 60 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 60 at risk

Adverse event: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 60 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 60 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 60 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 60 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 60 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 60 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 60 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 60 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 60 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 60 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 60 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 60 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 60 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 60 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 60 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: LOWER BACK PAIN
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: SWOLLEN JOINTS OF HANDS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: SWOLLEN LEFT ELBOW JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: SWOLLEN LEFT LEG
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 60 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 60 at risk

Adverse event: Neurology - Other: ANXIETY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: DIURNAL VARIATION OF MOOD
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: DROWSINESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: FEAR
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: FEARFUL TO USE FENTANYL BOLUSES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: FLAT AFFECT ON PSYCHOSOCIAL ASSESSMENT
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: FLAT EFFECT
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: FRUSTRATION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: IRRITABILITY (MOOD ALTERATION)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: LETHARGY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: NERVOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: NIGHTMARES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: NUMBNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Neurology - Other: PANIC ATTACK
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: RUMINATIVE, OBSESSIVE AND FEARFUL MUCH OF THE TIME
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: SLEEPINESS
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Neurology - Other: SOMNOLENCE
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: TINGLING SENSATION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: UNSTEADINESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: UNSTEADINESS BECAUSE OF VICODIN
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: VIBRATING SENSATION AT FEET WHILE WALKING
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neurology - Other: VIBRATING SENSATION AT TORSO WHILE SITTING
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neuropathy: cranial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 60 at risk

Adverse event: Speech impairment (e.g., dysphasia or aphasia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 60 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: CONGESTED CONJUNCTIVAL
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: CONJUNCTIVITIS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: DILATATION OF PUPIL (LT. EYE)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: IRRITATION
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: ITCHINESS OF EYES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: OD-VITREOUS OPACITY WITHOUT RETINAL DEFECT
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: PERIORBITAL PUFFINESS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: SLUGGISHNESS AND DILATATION OF RT. EYE PUPIL
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: SWOLLEN EYES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ocular/Visual - Other: TRANSIENT SPOTS IN FRONT OF EYES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ophthalmoplegia/diplopia (double vision)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 60 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Watery eye (epiphora, tearing)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 60 at risk

Adverse event: Pain - Other:
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: ABDOMINAL TENDERNESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: ACHES AND STRAINS OF CHEST WALL MUSCLES BECAUSE OF COUGHING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: BACK PAIN
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Pain - Other: BACK PAIN/BACK SPASM
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: BODY ACHES
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pain - Other: BURNING BLOOD-SHOT PAIN EYES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: CATHETER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: CHEST DISCOMFORT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: CHEST PRESSURE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: CVA TENDERNESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: DECUBITUS AREA PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: DIFFUSE ACHES AND PAINS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: DIFFUSE BUTTOCK AND SACRAL PAIN DUE TO DECUBITUS ULCER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: EPIGASTRIC PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: EPIGASTRIC PAIN WITH RADIATION TO BACK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: ESOPHAGEAL DISCOMFORT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: ESOPHAGEAL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: GENERALIZED ACHES AND TENDERNESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: GENERALIZED BODY ACHES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: HICKMAN CATHETER PAIN
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pain - Other: KNEES PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LEFT ARM AND SHOULDER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LEFT HAND PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LEFT LEG
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LEG PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pain - Other: LEGS PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LOW BACK PAIN WHILE ON RUNNING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LOWER BACK PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LT. FLANK PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LT. KNEE PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LT. NECK SWELLING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: LT. SHOULDER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: MOUTH PAIN
Serious: no
Organ System: General disorders
Frequency: 13 affected / 60 at risk

Adverse event: Pain - Other: PAIN AT BUTTOCKS DUE TO SHINGLES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN AT HANDS AND FEET
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN AT HICKMAN CATHETER EXIT SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN AT RAC EXIT SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN AT RUQ
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN DUE TO BP TAKING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN DUE TO LP PROCEDURE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN IN PALMS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAIN WHILE PASSING BLOOD CLOT IN FOLEY'S CATHETER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PALM PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: PAROTIDITIS (LT. SIDE)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: RAC SITE DISCOMFORT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: RAC SITE PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pain - Other: RIGHT ARM SORENESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: RIGHT FOREARM DISCOMFORT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: RUQ TENDERNESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: SCROTAL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: SHOULDER PAIN
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pain - Other: SINUS PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: SORE THROAT
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pain - Other: TENDER PALMS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TENDERNESS AT H. CATHETER SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TENDERNESS AT HICKMAN CATHETER SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TENDERNESS AT RUQ
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TENDERNESS OVER LEFT CHEECK SWELLING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TENDERNESS OVER SINUSES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: THROAT PAIN
Serious: no
Organ System: General disorders
Frequency: 16 affected / 60 at risk

Adverse event: Pain - Other: TOE AND FINGERTIP PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain - Other: TONGUE PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pain ABDOMINAL CRAMPING
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 60 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 60 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ASPIRATION PNEUMONIA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ATELECTASIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ATELECTASIS LLL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ATELECTASIS LT. MID LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ATELECTASIS OF RLL WITH ELEVATED DIAPHRAGM
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BIBASILAR RALES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BILATERAL DIFFUSE RALES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BILATERAL ELEVATION OF HEMIDIAPHRAGM
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BILATERAL RHONCHI
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BILATERAL SCATTERED CRACKLES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BLUNTING OF LT. COSTOPHRENIC ANGLE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CHEST TIGHTNESS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CHRONIC SNEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CLEAR SPUTUM PRODUCTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: COLD WITH NASAL DISCHARGE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CRACKLES AT LLL LUNGS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CRACKLES AT LUNG BASES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: CRACKLES AT RLL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LT. LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LUNG BASES
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND RT. LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: DECREASED BS AT RLL LUNG
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: DRY NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: ETHMOID SINUSITIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: EXPIRATORY WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: MUCUS OBSTRUCTION OF ET TUBE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: MUCUS PLUG LLL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL DRAINAGE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL SECRETION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL STUFFINESS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: OCCASIONAL RHONCHI
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: POST-NASAL DRAINAGE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: POST-NASAL DRIP
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: POSTNASAL DRIP
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: PULMONARY EDEMA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: PULMONARY VASCULAR CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RALES RT. LUNG BASE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RHONCHI BOTH LUNGS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RHONCHI RT. LOWER LOBE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RLL ATELECTASIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RLL INFILTRATE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RUNNING NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RUNNY NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SINUS CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SINUSITIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SNEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: STUFFY NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SUBSEGMENTAL ATELECTASIS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: TACHYPNEA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: UPPER AIRWAY CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: UPPER AIRWAY SWELLING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: WHEEZING
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: WHEEZING AFTER BLOOD TRANSFUSION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 60 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cystitis (COH)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: BLOOD CLOT IN FOLEY'S CATHETER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: BUN ELEVATED
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: DARK ORANGE COLOR URINE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: DIFFICULTY VOIDING
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: GENITAL SORES
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: INCONTINENCE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: OBSTRUCTIVE UROPATHY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Renal/Genitourinary - Other: PUL. OTHER/RHONCHI RT. LUNG BASE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 60 at risk

Adverse event: Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 60 at risk