Study: NCT01074970

Adverse event: SECONDARY MALIGNANCY - POSSIBLY RELATED TO CANCER TREATMENT (SPECIFY, __)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 65 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: ALLERGY/IMMUNOLOGY
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 65 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 65 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 65 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 65 at risk

Adverse event: AUDITORY/EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 65 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 65 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 65 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 2 affected / 65 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: DENTAL: TEETH
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: DERMATOLOGY/SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 65 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 8 affected / 65 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 65 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: 2 affected / 65 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 65 at risk

Adverse event: GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 65 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 65 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 65 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 / 65 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 65 at risk

Adverse event: HYPERPIGMENTATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 65 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: INFECTION - OTHER (SPECIFY, __)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 65 at risk

Adverse event: INFECTION WITH UNKNOWN ANC
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 65 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 65 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Investigations
Frequency: 13 affected / 65 at risk

Adverse event: LYMPHATICS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 65 at risk

Adverse event: LYMPHEDEMA-RELATED FIBROSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 65 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 65 at risk

Adverse event: METABOLIC/LABORATORY
Serious: no
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: MOOD ALTERATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 65 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 65 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 65 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 65 at risk

Adverse event: NEUROLOGY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 65 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 65 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 33 affected / 65 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 65 at risk

Adverse event: OTITIS, MIDDLE EAR (NON-INFECTIOUS)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 65 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 8 affected / 65 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 4 affected / 65 at risk

Adverse event: POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 65 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 65 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 65 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 65 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: RENAL/GENITOURINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 65 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 65 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 65 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 65 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 65 at risk

Adverse event: TRISMUS (DIFFICULTY, RESTRICTION OR PAIN WHEN OPENING MOUTH)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 65 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 65 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 65 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 65 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 65 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: MOOD ALTERATION
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 63 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 63 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: ALLERGY/IMMUNOLOGY
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 63 at risk

Adverse event: ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 63 at risk

Adverse event: AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 63 at risk

Adverse event: AUDITORY/EAR
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 63 at risk

Adverse event: BILIRUBIN (HYPERBILIRUBINEMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: CALCIUM, SERUM-LOW (HYPOCALCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 63 at risk

Adverse event: CONSTITUTIONAL SYMPTOMS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 63 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 63 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 63 at risk

Adverse event: DERMATOLOGY/SKIN
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 63 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 63 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 13 affected / 63 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 63 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: 3 affected / 63 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 63 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 63 at risk

Adverse event: HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 63 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 63 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 63 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 63 at risk

Adverse event: HYPERPIGMENTATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 63 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 63 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 63 at risk

Adverse event: INFECTION - OTHER (SPECIFY, __)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 63 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 63 at risk

Adverse event: INFECTION WITH UNKNOWN ANC
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 63 at risk

Adverse event: LEUKOCYTES (TOTAL WBC)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 63 at risk

Adverse event: LYMPHEDEMA-RELATED FIBROSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 63 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 63 at risk

Adverse event: MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 63 at risk

Adverse event: MOOD ALTERATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 63 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 63 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 63 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 63 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 63 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 63 at risk

Adverse event: NEUROLOGY
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 63 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 63 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 36 affected / 63 at risk

Adverse event: OCULAR/VISUAL
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 63 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 12 affected / 63 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 63 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 6 affected / 63 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 63 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 63 at risk

Adverse event: PSYCHOSIS (HALLUCINATIONS/DELUSIONS)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 63 at risk

Adverse event: SODIUM, SERUM-LOW (HYPONATREMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 63 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 63 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 63 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: VISION-BLURRED VISION
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 63 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 63 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: BLOOD/BONE MARROW
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 63 at risk

Adverse event: BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 63 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 63 at risk

Adverse event: CERVICAL SPINE-RANGE OF MOTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: DISTENSION/BLOATING, ABDOMINAL
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: EDEMA: HEAD AND NECK
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: EDEMA: TRUNK/GENITAL
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: EDEMA: VISCERA
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: ENTERITIS (INFLAMMATION OF THE SMALL BOWEL)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: EXTREMITY-LOWER (GAIT/WALKING)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 63 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 63 at risk

Adverse event: GASTROINTESTINAL - OTHER (SPECIFY, __)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: HEMORRHAGE, GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: HICCOUGHS (HICCUPS, SINGULTUS)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: INCONTINENCE, URINARY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: INTRA-OPERATIVE INJURY
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: MAGNESIUM, SERUM-HIGH (HYPERMAGNESEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 63 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: NEUROPATHY: CRANIAL
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: NEUROPATHY: MOTOR
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 63 at risk

Adverse event: OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: PHLEBOLYMPHATIC CORDING
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 63 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 63 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 7 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: 1 affected / 7 at risk

Adverse event: HAIR LOSS/ALOPECIA (SCALP OR BODY)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: HOT FLASHES/FLUSHES
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: INFECTION - OTHER (SPECIFY, __)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 7 at risk

Adverse event: MOOD ALTERATION
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 7 at risk

Adverse event: MUCOSITIS/STOMATITIS (CLINICAL EXAM)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 7 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: ARTHRITIS (NON-SEPTIC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: HEMORRHAGE, GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: JOINT-FUNCTION
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: PLEURAL EFFUSION (NON-MALIGNANT)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk