Study: NCT01142336

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: New or worsening Headache
Frequency: 7 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening Nausea
Frequency: 3 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening diarrhea
Frequency: 5 affected / 26 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening constipation
Frequency: 3 affected / 26 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: New or worsening upper respiratory infection
Frequency: 14 affected / 26 at risk

Adverse event: Memory Problems
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening memory problems
Frequency: 1 affected / 26 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening depressed mood
Frequency: 2 affected / 26 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening anxiety
Frequency: 3 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: New or worsening insomnia
Frequency: 7 affected / 26 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: New or worsening muscle pain
Frequency: 6 affected / 26 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: New or worsening muscle weakness
Frequency: 2 affected / 26 at risk

Adverse event: Elevated Blood Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Fasting Blood Glucose lab reading above normal limits
Frequency: 3 affected / 26 at risk

Adverse event: Elevated serum glutamic-oxaloacetic transaminase (SGOT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: SGOT lab reading above normal limits
Frequency: 3 affected / 26 at risk

Adverse event: Elevated Serum glutamic pyruvic transaminase (SGPT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: SGPT lab reading above normal limits
Frequency: 6 affected / 26 at risk

Adverse event: Elevated serum creatine phosphokinase (CPK)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: serum CPK lab reading above normal limits
Frequency: 7 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: New or worsening Headache
Frequency: 8 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening Nausea
Frequency: 2 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening diarrhea
Frequency: 2 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: New or worsening constipation
Frequency: 2 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: New or worsening upper respiratory infection
Frequency: 9 affected / 23 at risk

Adverse event: Memory Problems
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening memory problems
Frequency: 5 affected / 23 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening depressed mood
Frequency: 4 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Self-reported new or worsening anxiety
Frequency: 8 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: New or worsening insomnia
Frequency: 5 affected / 23 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: New or worsening muscle pain
Frequency: 8 affected / 23 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: New or worsening muscle weakness
Frequency: 1 affected / 23 at risk

Adverse event: Elevated Blood Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Fasting Blood Glucose lab reading above normal limits
Frequency: 5 affected / 23 at risk

Adverse event: Elevated serum glutamic-oxaloacetic transaminase (SGOT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: SGOT lab reading above normal limits
Frequency: 5 affected / 23 at risk

Adverse event: Elevated Serum glutamic pyruvic transaminase (SGPT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: SGPT lab reading above normal limits
Frequency: 1 affected / 23 at risk

Adverse event: Elevated serum creatine phosphokinase (CPK)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: serum CPK lab reading above normal limits
Frequency: 6 affected / 23 at risk