Study: NCT00001575

Adverse event: BLOOD/BONE MARROW:: Bone marrow cellularity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: HEPATIC:: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PULMONARY:: Pulmonary-Other (Specify, respiratory failure)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Abdominal pain or cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, tooth pain)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: PULMONARY:: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MDS
Frequency: 3 affected / 64 at risk

Adverse event: Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MDS/AML
Frequency: 1 affected / 64 at risk

Adverse event: Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: myelodysplastic syndrome
Frequency: 1 affected / 64 at risk

Adverse event: SYNDROMES:: Syndromes-Other (Specify, MDS)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 64 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 64 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 64 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify, sinus congestion)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 64 at risk

Adverse event: AUDITORY/HEARING:: Auditory/Hearing-Other (Specify, pressure in right ear)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 64 at risk

Adverse event: BLOOD/BONE MARROW:: Transfusion: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Prolonged QTc interval (QTc > 0.48 seconds)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 64 at risk

Adverse event: COAGULATION:: Partial thromboplastin time (PTT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 64 at risk

Adverse event: COAGULATION:: Prothrombin time (PT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 64 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
Serious: no
Organ System: General disorders
Notes: CONSTITUTIONAL SYMPTOMS
Frequency: 18 affected / 64 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, eczematoid dermatitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, rash; erythematous, eczematous)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, skin lesions)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 64 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 64 at risk

Adverse event: ENDOCRINE:: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 64 at risk

Adverse event: ENDOCRINE:: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal-Other (Specify, tongue discoloration)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 64 at risk

Adverse event: HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: HEMORRHAGE:: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: HEPATIC:: Alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 64 at risk

Adverse event: HEPATIC:: Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 64 at risk

Adverse event: HEPATIC:: Hypoalbuminemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 31 affected / 64 at risk

Adverse event: HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 64 at risk

Adverse event: HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 16 affected / 64 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Amylase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercholesterolemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypertriglyceridemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperuricemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc serum)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, serum zinc)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc, low)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc-serum (low))
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: MUSCULOSKELETAL:: Musculoskeletal-Other (Specify, Akathisia)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,muscle aches)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: MUSCULOSKELETAL:: Osteonecrosis (avascular necrosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: NEUROLOGY:: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 64 at risk

Adverse event: NEUROLOGY:: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 64 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other (Specify, transient vision lost)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 64 at risk

Adverse event: PAIN:: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 64 at risk

Adverse event: PAIN:: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 64 at risk

Adverse event: PAIN:: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 64 at risk

Adverse event: PAIN:: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 64 at risk

Adverse event: PAIN:: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, ankle)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, Back)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, jaw pain/tightness)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, pain Lt axilla surgical site)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, pain: Back:sacral area)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, Rt shoulder pain)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, Rt great toe pain: ingrown toenail)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pain-Other (Specify, Rt flank)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 64 at risk

Adverse event: PULMONARY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 64 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: PULMONARY:: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: PULMONARY:: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: PULMONARY:: Pulmonary-Other (Specify, upper respiratory infection)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: RENAL/GENITOURINARY:: Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 64 at risk

Adverse event: RENAL/GENITOURINARY:: Dysuria (painful urination)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: RENAL/GENITOURINARY:: Hemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 64 at risk

Adverse event: RENAL/GENITOURINARY:: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Specify, hesitancy)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: SEXUAL/REPRODUCTIVE FUNCTION:: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 64 at risk