Study: NCT01656031

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 39 affected / 39 at risk

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 39 affected / 39 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 38 affected / 39 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 37 affected / 39 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 26 affected / 39 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 23 affected / 39 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 23 affected / 39 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 22 affected / 39 at risk

Adverse event: Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 39 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 39 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 39 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 39 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Investigations
Frequency: 11 affected / 39 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 39 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 39 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 39 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 39 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 39 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 39 at risk

Adverse event: Lung Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 39 at risk

Adverse event: Bicarbonate serum-low
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 39 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 39 at risk

Adverse event: Pain: Skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 39 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 39 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 39 at risk

Adverse event: Alkalosis
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 39 at risk

Adverse event: Partial Thromboplastin Time
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 39 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 39 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Urinary Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: infection associated with Lymphopenia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Edema: viscera
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: Urinary with low grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: hemorrhage/bleeding into skin or mucosa
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Colitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 39 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 39 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 39 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 39 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Urinary tract Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Upper airway Infection with high grade neutropenia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Trachea Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Skin Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Nose Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Brain Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Bone Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: "Hemorrhage, pulmonary/upper respiratory"
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: "Hemorrhage, Vagina"
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: "Hemorrhage, Bladder"
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: "Hemorrhage, Lung"
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Rectum
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Esophagus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: functional obstruction of bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Face
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Death not associated with any term
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Chest/thorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 39 at risk

Adverse event: Iron overload
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Amylase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pain: Abdomen
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Mood alteration: Agitation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Edema: head and neck
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 39 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 21 affected / 39 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 27 affected / 39 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 17 affected / 39 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 8 affected / 39 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 39 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 39 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 6 affected / 39 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 39 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 39 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 39 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 15 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 39 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 27 affected / 39 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 39 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 27 affected / 39 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 30 affected / 39 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 39 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 39 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 19 affected / 39 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 31 affected / 39 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 39 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 15 affected / 39 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 7 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 39 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 39 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 16 affected / 39 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 39 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 18 affected / 39 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: General disorders
Frequency: 6 affected / 39 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 39 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 39 at risk

Adverse event: Edema: viscera
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 39 at risk

Adverse event: Confusional state
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 39 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 6 affected / 39 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 10 affected / 39 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 7 affected / 39 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 39 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 39 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Investigations
Frequency: 19 affected / 39 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: Investigations
Frequency: 5 affected / 39 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 39 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 39 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hemorrhage respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 39 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 39 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 4 affected / 39 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 8 affected / 39 at risk

Adverse event: Pain: Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Pericardial effusion (non-malignant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 39 at risk

Adverse event: hemorrhage/bleeding into skin or mucosa
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 39 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 39 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 39 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 39 at risk

Adverse event: Conjunctiva with neutropenia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 39 at risk

Adverse event: Pain: Bone
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Ataxia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 39 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Stomatitis/Pharygitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hemorrhage GU: Urinary
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 39 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Dental problems
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Supraventricular and nodal arrhythmia: Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain: Neck
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hemorrhage GI: Oral cavity
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain: Cardiac/heart
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Urinary retention (including neurogenic bladder)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 at risk