Study: NCT00069160

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS::
Serious: yes
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as AGC\<1.0 x 10e9/L)
Frequency: 1 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors, chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,musculoskeletal-lethargic)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Dizziness/lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: PULMONARY:: Pulmonary-Other (Specify,clinical deterioration)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: AUDITORY/HEARING:: Middle ear/hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Transfusion: pRBCs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 23 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: COAGULATION:: Partial thromboplastin time (PTT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 23 at risk

Adverse event: COAGULATION:: Prothrombin time (PT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify,_____)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: dermatology/skin: red peeling skin-face
Frequency: 1 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Radiation dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Gastrointestinal-Other (Specify,_____)
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastrointestinal: tooth fracture
Frequency: 1 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Mouth dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 23 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 23 at risk

Adverse event: HEMORRHAGE:: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: HEPATIC:: Alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: HEPATIC:: Bilirubin
Serious: no
Organ System: Investigations
Frequency: 5 affected / 23 at risk

Adverse event: HEPATIC:: Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 23 at risk

Adverse event: HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 23 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA::
Serious: no
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0x10e9/L, fever \>=38.5 degrees C)
Frequency: 3 affected / 23 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA::
Serious: no
Organ System: Infections and infestations
Notes: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 23 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypernatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 23 at risk

Adverse event: MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Ataxia (incoordination)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 23 at risk

Adverse event: NEUROLOGY:: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: NEUROLOGY:: Mood alteration-depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 23 at risk

Adverse event: NEUROLOGY:: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 23 at risk

Adverse event: NEUROLOGY:: Seizure(s)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Syncope (fainting
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: NEUROLOGY:: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: OCULAR/VISUAL:: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: OCULAR/VISUAL:: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: OCULAR/VISUAL:: Tearing (watery eyes)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 23 at risk

Adverse event: PAIN:: Abdominal pain or cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 23 at risk

Adverse event: PAIN:: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: PAIN:: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: PAIN:: Chest pain (non-cardiac and non-pleuritic)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: PAIN:: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 23 at risk

Adverse event: PAIN:: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralg
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: PAIN:: Pain-Other (Specify,___)
Serious: no
Organ System: Nervous system disorders
Notes: Back pain Hips + Legs pain-lumbar pain: back pain pain: sore throat pain: chest tube site pain: L flank lower pain: lower back pain pain: lower back
Frequency: 9 affected / 23 at risk

Adverse event: PULMONARY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 23 at risk

Adverse event: PULMONARY:: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: PULMONARY:: Pulmonary-Other (Specify,___)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pleural effusion (malignant)
Frequency: 2 affected / 23 at risk

Adverse event: PULMONARY:: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: RENAL/GENITOURINARY:: Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 23 at risk

Adverse event: PAIN:: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 23 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperuricemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS::
Serious: yes
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as AGC\<1.0 x 10e9/L)
Frequency: 2 affected / 25 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Thrombosis/embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE:: Rectal bleeding/hematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEPATIC:: Alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration-anxiety, agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: PULMONARY:: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Transfusion: pRBCs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 25 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 25 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: CARDIOVASCULAR (GENERAL):: Thrombosis/embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: COAGULATION:: Partial thromboplastin time (PTT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: COAGULATION:: Prothrombin time (PT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS:: Weight loss
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Nail changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Anorexia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Diarrhea patients without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Taste disturbance (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: HEPATIC:: Alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: HEPATIC:: Bilirubin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 25 at risk

Adverse event: HEPATIC:: Hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 25 at risk

Adverse event: HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA::
Serious: no
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC \<1.0x10e9/L, fever \>=38.5 degrees C)
Frequency: 2 affected / 25 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA::
Serious: no
Organ System: Infections and infestations
Notes: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: CPK (creatine phosphokinase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypercalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypermagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypomagnesemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypophosphatemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 25 at risk

Adverse event: NEUROLOGY:: Confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: NEUROLOGY:: Dizziness/lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: NEUROLOGY:: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration-depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: NEUROLOGY:: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Tearing (watery eyes)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN:: Abdominal pain or cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN:: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: PAIN:: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: PAIN:: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 25 at risk

Adverse event: PAIN:: Pain-Other (Specify,___)
Serious: no
Organ System: Nervous system disorders
Notes: Back pain Hips + Legs pain-lumbar pain: back pain pain: sore throat pain: chest tube site pain: L flank lower pain: lower back pain pain: lower back
Frequency: 2 affected / 25 at risk

Adverse event: PULMONARY:: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: PULMONARY:: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 25 at risk

Adverse event: PULMONARY:: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: PULMONARY:: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 25 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 25 at risk

Adverse event: PAIN:: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify,_____)
Serious: no
Organ System: Immune system disorders
Notes: allergy:reaction to tariquidar
Frequency: 1 affected / 25 at risk

Adverse event: BLOOD/BONE MARROW:: Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 20 affected / 25 at risk

Adverse event: CARDIOVASCULAR (ARRHYTHMIA):: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: DERMATOLOGY/SKIN:: Wound-non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Mucositis due to radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: GASTROINTESTINAL:: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 25 at risk

Adverse event: HEMORRHAGE:: CNS hemorrhage/bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: HEMORRHAGE:: Rectal bleeding/hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (Specify,____)
Serious: no
Organ System: Infections and infestations
Notes: infection-thrush
Frequency: 1 affected / 25 at risk

Adverse event: METABOLIC/LABORATORY:: Hyperuricemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: NEUROLOGY:: Mood alteration-anxiety, agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Ocular/Visual-Other (Specify,___)
Serious: no
Organ System: Eye disorders
Notes: uveitis
Frequency: 1 affected / 25 at risk

Adverse event: OCULAR/VISUAL:: Vision-blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: PAIN:: Earache (otalgia)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 25 at risk

Adverse event: PAIN:: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Dysuria (painful urination)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: RENAL/GENITOURINARY:: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk