Study: NCT01557959

Adverse event: Low WBC
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 44 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Low ANC
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 44 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 44 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Ocular/Visual - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Fever without neutropenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Urinary frequency/urgency
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 44 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 44 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Rash: acne/acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Partial Thromboplastin Time
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Arthritis (non-septic)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Chest wall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rash: dermatitis associated with radiation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: "Hemorrhage, GI: Duodenum"
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: "Hemorrhage, CNS"
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hearing: patients without baseline audiogram and not enrolled in a monitoring program
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 44 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: "Stricture/stenosis (including anastomotic), GI: Esophagus"
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain (unspecified)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Pleura
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 44 at risk

Adverse event: "Hemorrhage, GI: Rectum"
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: "Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS"
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection with unknown ANC: Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Vasovagal episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 44 at risk

Adverse event: Urinary with low grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Death not associated with CTCAE term: Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: "Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided"
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain: External ear
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Blood Infection with high grade neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Low WBC
Serious: no
Organ System: Investigations
Frequency: 41 affected / 44 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 41 affected / 44 at risk

Adverse event: Low Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 36 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 44 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 38 affected / 44 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 7 affected / 44 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 44 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 44 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Pulmonary/Upper Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 44 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 44 at risk

Adverse event: Neuropathy: motor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 44 at risk

Adverse event: Low ANC
Serious: no
Organ System: Investigations
Frequency: 37 affected / 44 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 44 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 7 affected / 44 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 44 at risk

Adverse event: Neurology
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 44 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 44 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 44 affected / 44 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 44 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 8 affected / 44 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 28 affected / 44 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 37 affected / 44 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 17 affected / 44 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 39 affected / 44 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 36 affected / 44 at risk

Adverse event: Bicarbonate serum-low
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 40 affected / 44 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 44 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 44 at risk

Adverse event: Pain: Head/headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 44 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 42 affected / 44 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 43 affected / 44 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 44 affected / 44 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 44 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 44 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 44 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 44 at risk

Adverse event: Auditory/Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 44 affected / 44 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 44 at risk

Adverse event: Edema: trunk/genital
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 44 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: General disorders
Frequency: 9 affected / 44 at risk

Adverse event: Mood alteration: Agitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 44 at risk

Adverse event: Pain: Abdomen
Serious: no
Organ System: General disorders
Frequency: 7 affected / 44 at risk

Adverse event: Acidosis
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 44 at risk

Adverse event: Partial Thromboplastin Time
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Joint
Serious: no
Organ System: General disorders
Frequency: 11 affected / 44 at risk

Adverse event: Arthritis (non-septic)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 9 affected / 44 at risk

Adverse event: Pain: Bone
Serious: no
Organ System: General disorders
Frequency: 10 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Bronchospasm wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Pain: Chest/thorax
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Pain: Chest wall
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 44 at risk

Adverse event: Hemorrhage respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 44 at risk

Adverse event: Neuropathy: cranial: CN VII Motor-face; Sensory-taste
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 42 affected / 44 at risk

Adverse event: "Watery eye (epiphora, tearing)"
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 19 affected / 44 at risk

Adverse event: Memory impairment
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hemorrhage GI: Oral cavity
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: General disorders
Frequency: 9 affected / 44 at risk

Adverse event: Pain: Muscle
Serious: no
Organ System: General disorders
Frequency: 8 affected / 44 at risk

Adverse event: Nail disorder
Serious: no
Organ System: General disorders
Frequency: 7 affected / 44 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Pleura
Serious: no
Organ System: General disorders
Frequency: 8 affected / 44 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rash: dermatitis associated with radiation: Chemoradiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 44 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Buttock
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pain: Tumor pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Nose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 44 at risk

Adverse event: Mucositis/stomatitis Oral cavity
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 44 at risk

Adverse event: Hemorrhage pulmonary/upper respiratory
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 44 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 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: 2 affected / 44 at risk

Adverse event: Neuropathy: cranial: CN VIII Hearing and balance
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 44 at risk