Study: NCT01402063

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac Event
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Constipation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Dysphagia/Swallowing Difficulty
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnea/Shortness of Breath/COPD
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Edema Cerebral/Brain Edema/Cerebral [Localized] Edema
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hemiparesis [Increasing] (LF Side)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Infection
Serious: yes
Organ System: Investigations
Notes: (Infection normal ANC, COPD/bronchitis, Thrush (esophageal infection), pneumonia (URI), UTI, bacterial meningitis)
Frequency: 3 affected / 41 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Investigations
Notes: ( confusion/altered mental status, concentration impairment, cognitive decline, delirium)
Frequency: 6 affected / 41 at risk

Adverse event: Nausea/Increased Nausea/Nausea [Increasing]
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Otitis (External)/ media/inflammation middle ear
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Seizure/Seizures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Syncope
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Embolism
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: White blood cell count
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: PLT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: ANC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: HCT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: RBC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: CSF elevated
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Cough
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: abnormal blood prolactin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: abrasions/lacerations: face, leg, finger
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Acne On Face and B/L Inguinal Region
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Agitation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Akathisia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: ALC Low/ALC Decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Alk Phos Elevated
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 22 affected / 41 at risk

Adverse event: LFTS (ALT/AST)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Ambulatory Dysfunction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 13 affected / 41 at risk

Adverse event: Anorexia/Decreased Appetite/Loss of Appetite
Serious: no
Organ System: Investigations
Frequency: 11 affected / 41 at risk

Adverse event: Anxiety/Anxiety [Increasing]
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Aphasia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: Aphasia (Motor)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Appetite (Increased)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: BILATERAL CAROTID BRUIT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Blurred Vision/Blurry Vision/homonymous hemianopsia(left)/cataracts/periorbital pressure
Serious: no
Organ System: Investigations
Frequency: 16 affected / 41 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Contusion
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: BUN lab
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: CD4 Count Decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: congestion/chest/ear
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: Chills
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 9 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: CSF elevated protein and collection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Cushingoid face
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: DARK LESION WITH IRREGULAR BORDERS - RIGHT MEDIAL ANKLE (BENIGN)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 10 affected / 41 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Dry skin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Dysphagia/Swallowing Difficulty
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Dyspnea/Shortness of Breath
Serious: no
Organ System: Investigations
Frequency: 7 affected / 41 at risk

Adverse event: dysgeuisa
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Edema Cerebral/Brain Edema/Cerebral [Localized] Edema
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Edema face/neck/hands
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Erythema
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue/Increased
Serious: no
Organ System: Investigations
Notes: Fatigue/Fatigue \[Intermittent\]/Fatigue \[Increasing\]/Fatigue (Worsening) - does not include somnolence
Frequency: 29 affected / 41 at risk

Adverse event: Facial asymmetry
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: Flushing
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Forehead trauma
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Gait Unsteadiness/Unsteady Gait/proprioception/ cirumduction, motor deficit
Serious: no
Organ System: Investigations
Frequency: 9 affected / 41 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Gum soarness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hand Cramping
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Hand tremor
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Headache/Headache (Bifrontal)/Headache [Intermittent]/pressure
Serious: no
Organ System: Investigations
Frequency: 17 affected / 41 at risk

Adverse event: Deafness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hemorrhage (Intratumoral)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hoarseness (Hoarse Voice)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 41 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hypersensitivity to noise
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 9 affected / 41 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: increased sputum
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Notes: (Infection normal ANC, COPD/bronchitis, Thrush (esophageal infection), pneumonia (URI), UTI, bacterial meningitis, sinusitis)
Frequency: 15 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 41 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: itchiness
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: intratumoral hemorrhage
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 41 at risk

Adverse event: Lipase increase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Lower Extremity Edema (Bilateral)/ foot swelling
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 41 at risk

Adverse event: Memory Loss (Worsening Short Term)/memory impairment
Serious: no
Organ System: Investigations
Frequency: 7 affected / 41 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Investigations
Notes: ( confusion/altered mental status, concentration impairment, cognitive decline, delirium) (hallucination), (irritability)
Frequency: 11 affected / 41 at risk

Adverse event: Narcolepsy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Nausea/Increased Nausea/Nausea [Increasing]
Serious: no
Organ System: Investigations
Frequency: 21 affected / 41 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Otitis (External)/ media/inflammation middle ear/tinnitus
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Notes: (chest, leg, knee, hip/back,foot, LE, neck, body aches, general, incisional, shoulder, arm, lower back, abdomen, joint, schiatica)
Frequency: 12 affected / 41 at risk

Adverse event: Paresthesia (Hand)/LE/oral/neuropathy
Serious: no
Organ System: Investigations
Frequency: 8 affected / 41 at risk

Adverse event: PLTs
Serious: no
Organ System: Investigations
Frequency: 17 affected / 41 at risk

Adverse event: Rash/skin irritation,seborrheic keratosis, desquamation of skin, maculopapular rash
Serious: no
Organ System: Investigations
Frequency: 6 affected / 41 at risk

Adverse event: Scrotal discomfort
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Seizure/Seizures
Serious: no
Organ System: Investigations
Frequency: 7 affected / 41 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Skin lesions/ulceration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Somnolence
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Swelling of Scalp [at Incision Site and Right Eyelid]
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Speech issues/vocal change
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Syncope
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Tachycardia (Sinus)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Toothache
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Tremor
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Embolism
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Wasting (General)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm)
Serious: no
Organ System: Investigations
Frequency: 15 affected / 41 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 41 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 41 at risk

Adverse event: Wheezing
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 4 affected / 41 at risk

Adverse event: Constipation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Investigations
Notes: ( confusion/altered mental status, concentration impairment, cognitive decline, delirium)
Frequency: 2 affected / 18 at risk

Adverse event: Nausea/Increased Nausea/Nausea [Increasing]
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Seizure/Seizures
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Embolism
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: PLT
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: intratumoral hemorrhage
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Craniotomy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: ALC Low/ALC Decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 18 at risk

Adverse event: Alopecia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: LFTS (ALT/AST)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 18 at risk

Adverse event: Anorexia/Decreased Appetite/Loss of Appetite
Serious: no
Organ System: Investigations
Frequency: 4 affected / 18 at risk

Adverse event: Anxiety/Anxiety [Increasing]
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Apathy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Bells palsy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Blurred Vision/Blurry Vision/homonymous hemianopsia(left)/cataracts/periorbital pressure
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Bloody mucous
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: CD4 Count Decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 6 affected / 18 at risk

Adverse event: Cough
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: cramping
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Cushingoid face
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Dehydration
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Depression
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Dyspnea/Shortness of Breath
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: dysgeuisa
Serious: no
Organ System: Investigations
Frequency: 5 affected / 18 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Edema face/neck/hands
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Erythema
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue/Increased
Serious: no
Organ System: Investigations
Notes: Fatigue/Fatigue \[Intermittent\]/Fatigue \[Increasing\]/Fatigue (Worsening) - does not include somnolence
Frequency: 16 affected / 18 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Fracture
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Gait Unsteadiness/Unsteady Gait/proprioception/ cirumduction, motor deficit
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Headache/Headache (Bifrontal)/Headache [Intermittent]/pressure
Serious: no
Organ System: Investigations
Frequency: 9 affected / 18 at risk

Adverse event: Hernia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 18 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hypertension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: incisional tenderness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Infection
Serious: no
Organ System: Investigations
Notes: (Infection normal ANC, COPD/bronchitis, Thrush (esophageal infection), pneumonia (URI), UTI, bacterial meningitis, sinusitis)
Frequency: 5 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 18 at risk

Adverse event: jaw stiffness/tenderness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 18 at risk

Adverse event: Memory Loss (Worsening Short Term)/memory impairment
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Investigations
Notes: ( confusion/altered mental status, concentration impairment, cognitive decline, delirium) (hallucination), (irritability)
Frequency: 1 affected / 18 at risk

Adverse event: mucous production increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Myopathy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Nausea/Increased Nausea/Nausea [Increasing]
Serious: no
Organ System: Investigations
Frequency: 11 affected / 18 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Ear pain/pressure
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Notes: (chest, leg, knee, hip/back,foot, LE, neck, body aches, general, incisional, shoulder, arm, lower back, abdomen, joint, schiatica)
Frequency: 5 affected / 18 at risk

Adverse event: Paresthesia (Hand)/LE/oral/neuropathy
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: PLTs
Serious: no
Organ System: Investigations
Frequency: 6 affected / 18 at risk

Adverse event: pain post herpatic neuralgia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Rash/skin irritation,seborrheic keratosis, desquamation of skin, maculopapular rash
Serious: no
Organ System: Investigations
Frequency: 4 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Psoriatic nails
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Seizure/Seizures
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: sinusitis/post nasal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: spasm extremity
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Toothache
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Ulcer
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 18 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk