Study: NCT02819479

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Month 6 Pt 20 min non-responsive but appeared awake. Ambulance. Brain MRI decr edema no acute infarct or hemorrh. D/C home. Another Pt month 6 seizure activity w dizziness, chest pain, left jaw pain and left arm pain and numbness, double vision
Frequency: 2 affected / 10 at risk

Adverse event: Acute encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Pt admitted month 9 for 1-Confusion 2-Intermittent diaphoresis 3-Heat/cold intolerance 4-Mild abd Pain 5-Vomiting 6-Unsteadiness. Brain CT/MRI no sig change target area, age related ischemic changes. Workup neg. Meds held pt improved D/Ced home.
Frequency: 1 affected / 10 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Nervous system disorders
Notes: Double vision on Day 1 with dizziness reported after transferred into TCU per protocol. Investigator notified, patient transferred to ICU, symptoms resolved 2 hours after onset.
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Pt has history of chest pain but symptoms worsened and were associated with Month 6 episode of seizures
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Month 9 Pt having recurrent worsening headaches, Brain MRI showed peri-lesion radiation necrosis with residual AVM. Pt opted for surgical resection of simple supra-tentorial AVM and Radiation necrosis in the Perisylvian and insular region.
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: Day 1 Double vision with dizziness reported after transferred into TCU per protocol. Investigator notified, patient transferred to ICU, symptoms resolved 2 hours after onset.
Frequency: 1 affected / 10 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Notes: Day 1 Pt developed acute onset Dysarthria followed by Lt. UE and LE Hemiparesis. Evaluated in ED, Brain CT/MRI and EEG revealed no sig changes, Hospitalized x 8 d started on steroids and Keppra (for poss seizure) weakness improved to LUE 5/5, LLE 3/5
Frequency: 1 affected / 10 at risk

Adverse event: Left Lower Extremity Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Notes: Day 1 Pt developed acute onset Dysarthria followed by Lt. UE and LE Hemiparesis. Evaluated in ED, Brain CT/MRI and EEG revealed no sig changes, Hospitalized x 8 d started on steroids and Keppra (for poss seizure) weakness improved to LUE 5/5, LLE 3/5
Frequency: 1 affected / 10 at risk

Adverse event: Left Upper Extremity Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Notes: Day 1 Pt developed acute onset Dysarthria followed by Lt. UE and LE Hemiparesis. Evaluated in ED, Brain CT/MRI and EEG revealed no sig changes, Hospitalized x 8 d started on steroids and Keppra (for poss seizure) weakness improved to LUE 5/5, LLE 3/5
Frequency: 1 affected / 10 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Notes: Month 8 Pt having symptoms of cerebral edema, Brain MRI showed interval increase in edema and radiation necrosis. Pt opted for 2 cycles of IV Avastin with subsequent improvement in symptoms and MRI findings.
Frequency: 1 affected / 10 at risk

Adverse event: 1st degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acne Related to Decadron
Frequency: 1 affected / 10 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Asthma episode
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bilateral lower leg edema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 10 at risk

Adverse event: Cervical strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cervical strain due to MVA
Frequency: 1 affected / 10 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Fracture Left Hand
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1 episode Frontal Headache from MVA; 1 episode Headache; 1 episode Right sided headache; 1 episode Headaches with vertigo; 3 episodes worsening headache
Frequency: 5 affected / 10 at risk

Adverse event: Generalized Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Generalized Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Head Trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Inability to focus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Inability to focus attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Incomplete Spontaneous Abortion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Increased dizziness
Frequency: 1 affected / 10 at risk

Adverse event: Eye twitches
Serious: no
Organ System: Eye disorders
Notes: Left eye twitches
Frequency: 1 affected / 10 at risk

Adverse event: Homonymous Hemianopia
Serious: no
Organ System: Eye disorders
Notes: Left Homonymous Hemianopia
Frequency: 1 affected / 10 at risk

Adverse event: Leg skin tear non-healing wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Left Leg skin tear non-healing wound
Frequency: 1 affected / 10 at risk

Adverse event: Leg traumatic injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Left leg traumatic injury
Frequency: 1 affected / 10 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blindness
Serious: no
Organ System: Eye disorders
Notes: loss of vision X 30 seconds
Frequency: 1 affected / 10 at risk

Adverse event: Lower Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Major depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild Abdominal Pain
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nosebleeds
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Personality Changes
Serious: no
Organ System: Psychiatric disorders
Notes: Personality Changes including anger
Frequency: 1 affected / 10 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 10 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: 1 episode Intermittent Numbness in the bottom; 1 episode Whole body numbness
Frequency: 2 affected / 10 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Left vertex scalp soreness
Frequency: 1 affected / 10 at risk

Adverse event: Ankle sprain due to fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Right ankle sprain due to fall
Frequency: 1 affected / 10 at risk

Adverse event: Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right Hip Radiating Pain
Frequency: 1 affected / 10 at risk

Adverse event: Inner Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Right Inner Ear pain
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: right knee pain from MVA
Frequency: 1 affected / 10 at risk

Adverse event: Cold sensation leg
Serious: no
Organ System: Nervous system disorders
Notes: Right leg cold sensation knee to foot
Frequency: 1 affected / 10 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Leg Muscle aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right Leg Muscle aches
Frequency: 1 affected / 10 at risk

Adverse event: Partial toenail ingrown
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right partial toenail ingrown
Frequency: 1 affected / 10 at risk

Adverse event: Calf muscle loss of tone
Serious: no
Organ System: Nervous system disorders
Notes: Rt Calf muscle loss of tone
Frequency: 1 affected / 10 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Generalized Seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tonic/clonic Seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Shot term memory problems
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Steroid Induced Hyperglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vision loss in left eye
Serious: no
Organ System: Eye disorders
Notes: temporary vision loss in left eye
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Traumatic Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 10 at risk

Adverse event: Trouble performing simple tasks
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Visual seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Whole body shaking associated with seizures
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening Acne on extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening of left sided weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Worsening of striae bilateral arms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk