Study: NCT02566304

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - subject 3
Frequency: 1 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: subject 33
Frequency: 1 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: subject 13
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: subject 33
Frequency: 1 affected / 35 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: subject 25
Frequency: 1 affected / 35 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: subject 12
Frequency: 1 affected / 35 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: subject 3
Frequency: 1 affected / 35 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: subject 22 and subject 28
Frequency: 2 affected / 35 at risk

Adverse event: Deliurm
Serious: yes
Organ System: Psychiatric disorders
Notes: subject 19
Frequency: 1 affected / 35 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Psychiatric disorders
Notes: subject 25
Frequency: 1 affected / 35 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Cardiac disorders
Notes: subject 7
Frequency: 1 affected / 35 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Notes: subject 11 \& 26
Frequency: 2 affected / 35 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: subject 1
Frequency: 1 affected / 35 at risk

Adverse event: Hepatobiliary disorder
Serious: yes
Organ System: Hepatobiliary disorders
Notes: subject 1
Frequency: 1 affected / 35 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: subject 25 and 28
Frequency: 2 affected / 35 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: subject 1,6,7,8,12,13,25,28,33,35
Frequency: 10 affected / 35 at risk

Adverse event: Infection & Infestations- Other fever
Serious: yes
Organ System: Infections and infestations
Notes: subject 3
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nervous System disorder- Aphasia
Serious: yes
Organ System: Nervous system disorders
Notes: subject 12
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: subject 12
Frequency: 1 affected / 35 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: subject 25 and 28
Frequency: 2 affected / 35 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: subject 33
Frequency: 1 affected / 35 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: subject 10
Frequency: 1 affected / 35 at risk

Adverse event: Wound-top of head
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Wound of Groin
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Wound on buttock
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 5 affected / 35 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 35 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: VRE
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 35 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Cardiac disorders
Notes: grade 1 \& 2
Frequency: 3 affected / 35 at risk

Adverse event: Vaginal cysts
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: UTI-VRE
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 9 affected / 35 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 2
Frequency: 8 affected / 35 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 12 affected / 35 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 7 affected / 35 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 5 affected / 35 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Psychiatric disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Tinea Cruis
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Vision changes
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: grades 1,2,3
Frequency: 6 affected / 35 at risk

Adverse event: Colitis
Serious: no
Organ System: Infections and infestations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Vitamin K deficiency
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Trouble swallowing
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected weight change
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: grade 1-2
Frequency: 6 affected / 35 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Psychiatric disorders
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: tissue disorders- other, skin tear
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Skin and Subcutaneous tissue disorders-other, sacrum sore
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders- other, erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders- other, keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: skin and subcutaneous tissue disorders- other, Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders, other excoriation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: grade 3
Frequency: 2 affected / 35 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Skin- Ashen color
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-
Frequency: 5 affected / 35 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: grade 1-2
Frequency: 17 affected / 35 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Vascular disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: subconjunctiva hemorrhage
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Pain of skin
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Scrotal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Scrotal oedema
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Scleral disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: grade 4
Frequency: 1 affected / 35 at risk

Adverse event: Right arm swelling
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1-2
Frequency: 17 affected / 35 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders- other, rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1-3
Frequency: 12 affected / 35 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Renal and urinary disorders- other, dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Proctalgia
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders- other, nasopharyngeal bleed
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Renal and Urinary disorders- hemorrhagic cystitis due to BK virus
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Reproductive system and breast disorders- other, scrotal edema
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Renal and urinary disorders- other, decreased urine output
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - other, tachypnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Renal and Urinary disorders- other, difficulty urinating
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Pleural effusions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade
Frequency: 4 affected / 35 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: grade 1-2
Frequency: 6 affected / 35 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Skin and subcutaneous tissue disorders- other, diaphoretic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Skin and subcutaneous disorders- other, pale
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Unspecified eye problem
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: taste change
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: skin and subcutaneous tissue disorders- other, Pallor
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Paresthesia pain
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grades 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Pain - general
Serious: no
Organ System: General disorders
Notes: grades 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Physical deconditioning
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Psychiatric disorders- other, decreased concentration
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 2 affected / 35 at risk

Adverse event: patchy spots on tongue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Pruritic raised erythematous rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Night sweats
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Neuro-weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 20 affected / 35 at risk

Adverse event: Non- cardiac chest pain
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Nervous System Disorders- other, Altered MS with Aphasia
Serious: no
Organ System: Nervous system disorders
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Neoplasms benign, malignant and unspecified (in cyss and polyps)- other, bump on left arm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Nosebleeds
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 5 affected / 35 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 3
Frequency: 21 affected / 35 at risk

Adverse event: MRSA - skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Musculoskeletal and connective tissue disorder- other, Charlie HOrse
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Musculoskeletal and connective tissue disorders- other, unsteadiness on feet
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 4 affected / 35 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Musculoskeletal and connective tissue disorders- other, physical deconditioning
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Muscle weakness in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Metabolism and nutrition disorders- electrolyte disturbances
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 2-3
Frequency: 3 affected / 35 at risk

Adverse event: Lump on right forearm
Serious: no
Organ System: Endocrine disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Loss of smell/taste
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Lethargy/Fatigue
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Left pericatheter thrombus
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: LE edema
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Left Axilla swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Irregular heart ryhythm
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1-2
Frequency: 15 affected / 35 at risk

Adverse event: Infusion Related Reaction - rigors
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Infusion related reaction- Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Infusion related reaction- headache
Serious: no
Organ System: Nervous system disorders
Notes: grade 1-2
Frequency: 1 affected / 35 at risk

Adverse event: Infusion related reaction- chills
Serious: no
Organ System: Infections and infestations
Notes: grade 1-2
Frequency: 2 affected / 35 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 12 affected / 35 at risk

Adverse event: Infection and Infestations- other (fever)
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 4 affected / 35 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Increased LFT's
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: infections and infestations- other, CMV reactivation
Serious: no
Organ System: Infections and infestations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations- other, cellulitis
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 6 affected / 35 at risk

Adverse event: Iron overload
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Injury, poisoning and procedural complications- other, wounds
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: injury, poisoning and procedural complications- other, scrotal bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: injury, poisoning and procedural complications- other, pressure ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: injury, poisoning and procedural complications- other, parotitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: injury, poisoning and procedural complications- other, GI bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Infusion related reaction- hypotension
Serious: no
Organ System: Vascular disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations- other, HHV-6
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations- other, CMV Viremia
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations- other, bacteremia
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 4 affected / 35 at risk

Adverse event: injury, poisoning and procedural complications- other ecchymosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: infections and infestations- other, epididmoorchitis
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: infections and infestations- other, covid-19
Serious: no
Organ System: Infections and infestations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: intermittent hyperglycemia
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: intermittent fatigue
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: intermittent dizziness
Serious: no
Organ System: Nervous system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Phantom limb syndrome
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Oral pain
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Metabolism and nutritional disorders- other, vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 2-3
Frequency: 19 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 35 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: grade 1-2
Frequency: 12 affected / 35 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Endocrine disorders
Notes: grade 2
Frequency: 7 affected / 35 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Hot flush
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Hive
Serious: no
Organ System: Immune system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 14 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 13 affected / 35 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 6 affected / 35 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 6 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 6 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 2 affected / 35 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Investigations
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 35 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Notes: grade 3
Frequency: 5 affected / 35 at risk

Adverse event: Heel pain
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Hoarsness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 7 affected / 35 at risk

Adverse event: General Disorders and administration site conditions - other Diaphoresis
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: General disorders and administration site conditions- other, generalized aches
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal disorders- other, Oral ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 2
Frequency: 7 affected / 35 at risk

Adverse event: General disorders and administration site conditions- other fluid overload
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 8 affected / 35 at risk

Adverse event: Gatrointestinal disorders- other oral blister
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 2
Frequency: 4 affected / 35 at risk

Adverse event: Gastrointestinal disorders- other, "itchy" mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: General disorders and administration site disorders- other, night sweats
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: general disorders and administration site conditions- other, bleeding event
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: gastrointestinal disorders- other, Perirectal irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: gastrointestinal disorders- other, pain at PEG site
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: gastrointestinal disorders- other, hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal disorders- other, tongue coating
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Foot and Leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 11 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: grade 1-3
Frequency: 31 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: grade 1 -3
Frequency: 29 affected / 35 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Elevated total bilirubin level
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Cardiac disorders
Notes: grade 3
Frequency: 3 affected / 35 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Notes: grade 1-2
Frequency: 17 affected / 35 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Eye disorders - other, blind in right eye
Serious: no
Organ System: Eye disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Eye disorders, other Diplopia
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Excoriation - scrotum
Serious: no
Organ System: Reproductive system and breast disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: ear and labyrinth disorders- other, ear fullness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: eye disorders- other, farsightedness
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 2
Frequency: 3 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 17 affected / 35 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 10 affected / 35 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: grade 1-2
Frequency: 4 affected / 35 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 32 affected / 35 at risk

Adverse event: Gastric dilatation
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Discomfort at foley site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1-2
Frequency: 11 affected / 35 at risk

Adverse event: decreased PO intake
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: grade 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 6 affected / 35 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 2
Frequency: 5 affected / 35 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: deconditioning
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: dehyrdration
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 3 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1-2
Frequency: 13 affected / 35 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 15 affected / 35 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1-2
Frequency: 9 affected / 35 at risk

Adverse event: CMV reactivation
Serious: no
Organ System: Infections and infestations
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 12 affected / 35 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 5 affected / 35 at risk

Adverse event: Cardio disorders- other, murmur
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: crushingoid
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Psychiatric disorders
Notes: grade 3
Frequency: 4 affected / 35 at risk

Adverse event: crackles at lung bases
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: General disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Notes: grade 3
Frequency: 1 affected / 35 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Hepatobiliary disorders
Notes: grade 1-2
Frequency: 13 affected / 35 at risk

Adverse event: bladder pressure
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: bibasilar atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: back pain and stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 35 at risk

Adverse event: buttocks pain
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: blood and lymphatic system disorders- other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 5
Frequency: 1 affected / 35 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Blood blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Bone pain
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 1 affected / 35 at risk

Adverse event: bilateral pam itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: bilateral leg cramp
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: bilateral edema
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: awakening to urinate
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1
Frequency: 3 affected / 35 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: grade 2
Frequency: 2 affected / 35 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 6 affected / 35 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: grade 1
Frequency: 11 affected / 35 at risk

Adverse event: Agitated/ Irritable
Serious: no
Organ System: Psychiatric disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Acidy mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Achiness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 2 affected / 35 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1-2
Frequency: 19 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 4 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: grade 1
Frequency: 7 affected / 35 at risk

Adverse event: alkaline phosphate increased
Serious: no
Organ System: Investigations
Notes: grade 1
Frequency: 5 affected / 35 at risk

Adverse event: abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 7 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: grade 1-2
Frequency: 20 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: grade 1-4
Frequency: 4 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: grade 1-2
Frequency: 10 affected / 35 at risk

Adverse event: Aspiration
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Notes: grade 2
Frequency: 1 affected / 35 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: altered taste
Serious: no
Organ System: General disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: atrial fibrillation RVR
Serious: no
Organ System: Cardiac disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: grade 1
Frequency: 1 affected / 35 at risk