Study: NCT00534430

Adverse event: Leukocytes (total WBC) for BMT studies, if specified in the protocol.
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Allergy/Immunology - Other: DRY NOSE
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Allergy/Immunology - Other: ENGRAFTMENT SYNDROME
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Auditory/Ear - Other: DECREASED HEARING DUETO MEDS (AZITHROMYCIN)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Auditory/Ear - Other: PLUGGED EARS
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Otitis, external ear (non-infectious)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: General disorders
Frequency: 14 affected / 30 at risk

Adverse event: Veno-Occlusive Disease (VOD)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Blood/Bone Marrow - Other (Specify, __)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bone marrow cellularity
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 30 at risk

Adverse event: Hemoglobin for leukemia studies or bone marrow infiltrative/ myelophthisic processes.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 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: 23 affected / 30 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 30 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 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: 24 affected / 30 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Platelets for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 30 at risk

Adverse event: Transfusion: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Transfusion: Platelets for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 30 at risk

Adverse event: Transfusion: pRBCs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Transfusion: pRBCs for BMT studies, if specified in the protocol.
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 30 at risk

Adverse event: Acute graft versus host disease (GVHD) (COH)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 30 at risk

Adverse event: Chronic graft versus host disease (GVHD) (COH)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac Arrhythmia - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Supraventricular and nodal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 30 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac General - Other (Specify, __)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac General - Other: CARDIOMEGALY
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 30 at risk

Adverse event: Myocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 30 at risk

Adverse event: INR (International Normalized Ratio of prothrombin time)
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 30 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Constitutional Symptoms - Other (Specify, __)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 30 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: 12 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 30 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 20 affected / 30 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol.
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 16 affected / 30 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 / 30 at risk

Adverse event: Dermatology/Skin - Other: ACTINIC PARAKERATIONS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: BRUISE ON RIGHT ARM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: BURNING SENSATION IN ARM PITS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: CONTACT DERMATITIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: DIFFUSE ERYTHEMATOUS SCROTUM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: EDEMA DUE TO BM BIOPSY
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: FACIAL PLETHORA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: FACIAL SWELLING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: INGROWN TOENAIL
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: INTRAVASCULAR MICROTHROMBI - LEFT THIGH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: LEFT HIP ABRASION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: LIP LESION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PALLOR
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PAROTID SWELLING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PERI-RECTAL EXCORIATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PERIANAL AREA SKIN IRRITATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PERIRECTAL AREA SKIN IRRITATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: PERIRECTAL ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: RASH SECONDARY CHEMO
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: REDNESS ON SCROTUM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: ROSACEA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: SCROTAL RASH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: SKIN/JAUNDICE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: UP ORAL ULCER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: VP-16 RASH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatology/Skin - Other: VP-16 SKIN RASH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 30 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 30 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 30 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pigmentation changes (e.g., vitiligo)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 30 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 30 at risk

Adverse event: Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 30 at risk

Adverse event: Rash/desquamation associated with graft versus host disease (GVHD).
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 30 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 30 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 30 at risk

Adverse event: Ascites (non-malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Diarrhea associated with graft versus host disease (GVHD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 30 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dysphagia-esophageal related to radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL BLOATING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL BLOATNESS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL CRAMPS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ABDOMINAL DISTENSION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: CHOLECYSTITIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: DRY HEAVES
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Gastrointestinal - Other: DRY MOUTH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: EPIGASTRIC DISCOMFORT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ERYTHEMA STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ESOPHAGEAL DISCOMFORT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: FREQUENT STOOLS (NOT DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: GAGGING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: GERD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: GURGLY STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: INCREASED SALIVATION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: ORAL THRUSH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: RECTAL LESION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: RED THROAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: RETCHING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Gastrointestinal - Other: SCRATCHY THROAT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: SMALL POLYPS STOMACH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: SWELLING OF CHECKS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: UPPER GI/GVHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: WRECHING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrointestinal - Other: WRETCHING
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 30 at risk

Adverse event: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 30 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol.
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 30 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 30 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 30 at risk

Adverse event: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 30 at risk

Adverse event: Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 30 at risk

Adverse event: Melena/GI bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rectal bleeding/hematochezia
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hemorrhage, GU
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 30 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM PENIS MEATUS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLEEDING FROM SCRATCH
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD IN SPUTUM
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: BLOOD TINGLED MUCUS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: HEMORRHOIDS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: SPUTUM WITH BLOODSTREAM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: SUBCONJUNCTIVAL HEMORRHAGE
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: TELANGIECTASIA CHEST
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hemorrhage/Bleeding - Other: TONGUE BLEEDING
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 30 at risk

Adverse event: Bilirubin associated with graft versus host disease (GVHD).
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hepatic enlargement
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hepatobiliary/Pancreas - Other: JAUNDICE
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 30 at risk

Adverse event: Infection - Other (Specify, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection - Other: ORAL CANDIDIASIS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection - Other: UPPER RESPIRATORY INFECTION
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 30 at risk

Adverse event: Infection (documented) with grade 3 or 4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 30 at risk

Adverse event: Infection with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 30 at risk

Adverse event: Infection, Bacterial (COH)
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 30 at risk

Adverse event: Infection, Fungal (COH)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 30 at risk

Adverse event: Infection, Viral
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 30 at risk

Adverse event: Lymphatics - Other: LYMPHADENOPATHY
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphatics CERVICAL LYMPHOADENOPATHY
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lymphatics MILD LYMPHEDEMIA (NECK)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 30 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 30 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 30 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 30 at risk

Adverse event: Alkalosis (metabolic or respiratory)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Bicarbonate, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 30 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 30 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 30 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 30 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 30 at risk

Adverse event: GGT (gamma-Glutamyl transpeptidase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 30 at risk

Adverse event: Glucose, serum-low (hypoglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 30 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 30 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 30 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 30 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 30 at risk

Adverse event: Sodium, serum-high (hypernatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 30 at risk

Adverse event: Triglyceride, serum-high (hypertriglyceridemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Uric acid, serum-high (hyperuricemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 30 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 / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: DEGERATIVE CHANGES IN ANTERIOR THORACIC SPINE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: HAND CRAMPS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS-FINGERS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: MUSCLE SPANAM
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: MUSCLE SPASM
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other: NUMBNESS, TINGLING
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 30 at risk

Adverse event: Hallucination
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 30 at risk

Adverse event: Neurology - Other: ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSION
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology - Other: METABOLIC ENCEPHALOPATHY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology - Other: NIGHTMARES
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neurology - Other: PANIC ATTACK
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Personality/behavioral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Psychosis (hallucinations/delusions)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyramidal tract dysfunction (increased tone, hyperreflexia, pos Babinski, decreased motor coord
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 30 at risk

Adverse event: Syncope (fainting)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 30 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 30 at risk

Adverse event: Ocular/Visual - Other: CHEMON'S--SCLERAL EDEMA
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual - Other: ICTERIC SCLERAE
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual - Other: JAUNDICED SCLERAL
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual - Other: RED EYES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual - Other: REDNESS (NOT DRY)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ocular/Visual - Other: YELLOW DISCHARGE FROM THE EYES
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 30 at risk

Adverse event: Pain - Other: ARM PIT PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: BACK PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other: BODY ACHE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: CATHETER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: CRAMPING (ABDOMINAL)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: DRY HEAVES
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: EAR PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: EPIGASTRIC PAIN
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain - Other: GENERALIZED BODY PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other: HANDS PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: HICKMAN CATHETER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: HICKMAN SITE PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other: HIP PAIN (DUE TO BIOPSY)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: INGROWN TOENAIL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: KNEE PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: LEG PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: LOW BACK PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: MOUTH PAIN
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain - Other: NECK PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other: PAIN AT RAC SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: PAIN FROM BM BIOPSY SITE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: PAIN IN MANDIBLE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: PAIN SYNDROME DUE TO MUCOSITIS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: PAIN TO LYMPH NODE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: PAROTID PAIN
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain - Other: PERIRECTAL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: R. ARM PAIN FROM THE FALL
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: RAC SITE PAIN
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pain - Other: RIB PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: SCROTAL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: SHOULDER PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: SKIN PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: SUBMANDIBULAR TENDERNESS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: TENDER PAROTID GLANDS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: THIGH PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: THROAT PAIN
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pain - Other: THROAT PAIN (POSSIBLE URI)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: TONGUE PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain - Other: TWINGES FEET
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain RECTAL PAIN
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Adult Respiratory Distress Syndrome (ARDS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 30 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: BRONCHOSPASM
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 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 / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: EXCORIATION OF POSTERIOR
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: MILD ELEVATION OF RIGHT HEMIDIAPHRAGM
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL STUFFINESS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: NASAL/SINUS CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: PULMONARY VASCULAR CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RESPIRATORY DISTRESS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: RUNNING NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SINUS CONGESTION/RUNNY NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: SINUS/NOSE CONGESTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: TACHYPNEA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: UPPER AIRWAY OBSTRUCTION
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pulmonary/Upper Respiratory - Other: URI
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 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: 9 affected / 30 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary - Other (Specify, __)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Renal/Genitourinary - Other: VAG. DISCHARGE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Libido
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vaginitis (not due to infection)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 30 at risk

Adverse event: Syndromes - Other: RASH GVHD
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk