Study: NCT00540644

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: CARDIAC GENERAL - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: PAIN - BACK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 48 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: FLU-LIKE SYNDROME
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 48 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 48 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 14 affected / 48 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 24 affected / 48 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: 5 affected / 48 at risk

Adverse event: PAIN - CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 6 affected / 48 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 6 affected / 48 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 48 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: METABOLIC/LABORATORY - OTHER
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 48 at risk

Adverse event: PLATELETS
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 48 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 48 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 48 at risk

Adverse event: PAIN - BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 48 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 48 at risk

Adverse event: PAIN - JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 48 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: PAIN - NECK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 48 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 48 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 48 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 48 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 48 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 48 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 48 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: NASAL CAVITY/PARANASAL SINUS REACTIONS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: PAIN - THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 48 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 48 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: PAIN - BACK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: AUDITORY/EAR - OTHER
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 22 at risk

Adverse event: OTITIS, MIDDLE EAR (NON-INFECTIOUS)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 22 at risk

Adverse event: OCULAR/VISUAL - OTHER
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 22 at risk

Adverse event: DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: DYSPHAGIA (DIFFICULTY SWALLOWING)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: HEARTBURN/DYSPEPSIA
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: PAIN - ABDOMEN NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: PAIN - PELVIS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: EDEMA: LIMB
Serious: no
Organ System: General disorders
Frequency: 8 affected / 22 at risk

Adverse event: FATIGUE (ASTHENIA, LETHARGY, MALAISE)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 22 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: 7 affected / 22 at risk

Adverse event: PAIN - CHEST/THORAX NOS
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: PAIN - FACE
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: PAIN - OTHER
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: RIGORS/CHILLS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: INFECTION - OTHER
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - DENTAL-TOOTH
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 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 / 22 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTEREMIA)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: HEARING: PATIENTS WITH/WITHOUT BASELINE AUDIOGRAM AND ENROLLED IN A MONITORING PROGRAM
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: METABOLIC/LABORATORY - OTHER
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: NEUTROPHILS/GRANULOCYTES (ANC/AGC)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 22 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: POTASSIUM, SERUM-LOW (HYPOKALEMIA)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTRAOCULAR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-UPPER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: MUSCULOSKELETAL/SOFT TISSUE - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: OSTEONECROSIS (AVASCULAR NECROSIS)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: PAIN - BACK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 22 at risk

Adverse event: PAIN - BONE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 22 at risk

Adverse event: PAIN - EXTREMITY-LIMB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 22 at risk

Adverse event: PAIN - JOINT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 22 at risk

Adverse event: PAIN - MUSCLE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: PAIN - NECK
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: ATAXIA (INCOORDINATION)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 22 at risk

Adverse event: NEUROPATHY: SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 22 at risk

Adverse event: PAIN - HEAD/HEADACHE
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: PAIN - SINUS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: SYNCOPE (FAINTING)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: TASTE ALTERATION (DYSGEUSIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 22 at risk

Adverse event: MOOD ALTERATION - ANXIETY
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: MOOD ALTERATION - DEPRESSION
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: RENAL/GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: URINARY FREQUENCY/URGENCY
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 22 at risk

Adverse event: DYSPNEA (SHORTNESS OF BREATH)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 22 at risk

Adverse event: HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: PAIN - THROAT/PHARYNX/LARYNX
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: PULMONARY/UPPER RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: DERMATOLOGY/SKIN - OTHER
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: PRURITUS/ITCHING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: RASH/DESQUAMATION
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 22 at risk

Adverse event: RASH: ACNE/ACNEIFORM
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: SWEATING (DIAPHORESIS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: THROMBOSIS/THROMBUS/EMBOLISM
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk