Study: NCT01255163

Adverse event: Myocardiac Infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardiac Infarction treated with cardiac stent placement
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD
Frequency: 2 affected / 13 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild lower abdominal pain (all causes)
Frequency: 1 affected / 13 at risk

Adverse event: Pancreatic enzyme elevation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Asymptomatic elevation (over the upper normal limit) in serum amylase (and/or pancreatic-specific amylase) and/or serum lipase
Frequency: 2 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild intermittent diarrhea (all causes)
Frequency: 3 affected / 13 at risk

Adverse event: Loss of appetite/weight loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Loss of appetite leading to weight loss \> 5 lb
Frequency: 4 affected / 13 at risk

Adverse event: Hypoglycemia symptoms
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild episodic symptoms consistent with hypoglycemia and relieved by meal (episodic fatigue and/or dizziness and/or lightheadedness and/or diaphoresis and/or nervousness and/or tremulousness). No episodes of severe symptomatic hypoglycemia.
Frequency: 3 affected / 13 at risk

Adverse event: Injection site ecchymosis and pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abnormal kidney function tests
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevation in serum BUN and/or creatinine and/or GFR (over the upper normal limit)
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Thyroid abnormalities
Serious: no
Organ System: Endocrine disorders
Notes: Two participants had changes in thyroid function tests (TSH and/or T4 or FT4) requiring a change in thyroxine regimen. One of them (placebo-treated) had symptomatic hypothyroidism. One placebo participant had thyroid nodules biopsied (benign).
Frequency: 1 affected / 13 at risk

Adverse event: Post lumbar puncture headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post lumbar puncture headache (all types). LP takes place during screening and at the 18 month outcome visit. One participant required blood patch after common analgesics and hydration did not provide relief.
Frequency: 3 affected / 13 at risk

Adverse event: Orthopedic injuries
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractures (all types), lower back pain, strain, etc.
Frequency: 2 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Vomiting from lying flat on the MRI table
Frequency: 1 affected / 13 at risk

Adverse event: Vasovagal syncope
Serious: no
Organ System: Nervous system disorders
Notes: One participant had syncope during the LP procedure (the participant had hiatal hernia and the pressure from bending over caused nausea and vasovagal syncope). Another participant had syncope during a boar ride and experiencing sea sickness.
Frequency: 2 affected / 13 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

Adverse event: Allergic conjuctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lung cancer diagnosed after pathological fracture 2 days after starting experimental drug
Frequency: 1 affected / 14 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: GERD
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatic enzyme elevation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Asymptomatic elevation (over the upper normal limit) in serum amylase (and/or pancreatic-specific amylase) and/or serum lipase
Frequency: 2 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild intermittent diarrhea (all causes)
Frequency: 1 affected / 14 at risk

Adverse event: Hypoglycemia symptoms
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Mild episodic symptoms consistent with hypoglycemia and relieved by meal (episodic fatigue and/or dizziness and/or lightheadedness and/or diaphoresis and/or nervousness and/or tremulousness). No episodes of severe symptomatic hypoglycemia.
Frequency: 2 affected / 14 at risk

Adverse event: Injection site ecchymosis and pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abnormal kidney function tests
Serious: no
Organ System: Renal and urinary disorders
Notes: Elevation in serum BUN and/or creatinine and/or GFR (over the upper normal limit)
Frequency: 2 affected / 14 at risk

Adverse event: Thyroid abnormalities
Serious: no
Organ System: Endocrine disorders
Notes: Two participants had changes in thyroid function tests (TSH and/or T4 or FT4) requiring a change in thyroxine regimen. One of them (placebo-treated) had symptomatic hypothyroidism. One placebo participant had thyroid nodules biopsied (benign).
Frequency: 2 affected / 14 at risk

Adverse event: Post lumbar puncture headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Post lumbar puncture headache (all types). LP takes place during screening and at the 18 month outcome visit. One participant required blood patch after common analgesics and hydration did not provide relief.
Frequency: 3 affected / 14 at risk

Adverse event: Orthopedic injuries
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractures (all types), lower back pain, strain, etc.
Frequency: 2 affected / 14 at risk

Adverse event: Lacunar stroke
Serious: no
Organ System: Nervous system disorders
Notes: Asymptomatic subacute lacunar stroke discovered during ER work-up.
Frequency: 1 affected / 14 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnea on exertion
Serious: no
Organ System: Cardiac disorders
Notes: Worsening DOE in participant with pre-existing cardiomyopathy
Frequency: 1 affected / 14 at risk