Study: NCT00814138

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject admitted to hospital for Pancreatitis. Determined to not be study medication related.
Frequency: 1 affected / 25 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject was admitted to the hospital for possible thrombosis.
Frequency: 1 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General Pain - not limited to a specific area
Frequency: 13 affected / 25 at risk

Adverse event: Elevation of liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated ALTs, ASTs or bilirubin was reported
Frequency: 3 affected / 25 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Infections included sinus infections, upper respiratory infections
Frequency: 13 affected / 25 at risk

Adverse event: Allergic
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Most described as upset stomach, diarrhea, constipation
Frequency: 15 affected / 25 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Described as shortness of breath
Frequency: 9 affected / 25 at risk

Adverse event: Edema/bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Described as swelling in ankles and legs, increased bruising in the arms.
Frequency: 6 affected / 25 at risk

Adverse event: Ophthalomologic
Serious: no
Organ System: Eye disorders
Notes: Described as blurry vision
Frequency: 5 affected / 25 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Described as dry skin
Frequency: 3 affected / 25 at risk

Adverse event: Constitutional/other
Serious: no
Organ System: General disorders
Notes: General fatigue
Frequency: 10 affected / 25 at risk

Adverse event: Muscle weakness/fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worsening of the myasthenia gravis symptoms
Frequency: 10 affected / 25 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 25 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Subject died after suffering a stroke at month 10. This was reviewed by the safety monitor and deemed not study medication related.
Frequency: 1 affected / 25 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Subject was admitted to the hospital for possible thrombosis.
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant admitted to the hospital for shortness of breath. This occurred between the screening visit and the baseline visit; therefore no medication had been dispensed at that time.
Frequency: 1 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General Pain - not limited to a specific area
Frequency: 14 affected / 25 at risk

Adverse event: Elevation of liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated ALTs, ASTs or bilirubin was reported
Frequency: 4 affected / 25 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Infections included sinus infections, upper respiratory infections
Frequency: 7 affected / 25 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Most described as upset stomach, diarrhea, constipation
Frequency: 11 affected / 25 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Described as shortness of breath
Frequency: 7 affected / 25 at risk

Adverse event: Edema/bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Described as swelling in ankles and legs, increased bruising in the arms.
Frequency: 7 affected / 25 at risk

Adverse event: Ophthalomologic
Serious: no
Organ System: Eye disorders
Notes: Described as blurry vision
Frequency: 4 affected / 25 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Described as dry skin
Frequency: 5 affected / 25 at risk

Adverse event: Constitutional/other
Serious: no
Organ System: General disorders
Notes: General fatigue
Frequency: 8 affected / 25 at risk

Adverse event: Muscle weakness/fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worsening of the myasthenia gravis symptoms
Frequency: 8 affected / 25 at risk

Adverse event: Hematologic
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 25 at risk