Study: NCT00630734

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 8 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 32 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 32 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 32 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 32 at risk

Adverse event: Shoulder/Neck Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 8 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 5 affected / 31 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 31 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 31 at risk

Adverse event: Nausea/Vomiting/Dyspepsia/Abdominal Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 12 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 8 affected / 31 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 31 at risk

Adverse event: Shoulder/Neck Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 31 at risk

Adverse event: Angioedema
Serious: yes
Organ System: General disorders
Notes: 1 patient experienced grade 2 angioedema (as described by DAIDS criteria). This was not technically SAE, but did require pharmacologic intervention to prevent a more serious reaction.
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 6 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 28 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: General disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 2 affected / 28 at risk

Adverse event: Nausea/Vomiting/Dyspepsia/Abdominal Pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 3 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 13 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 28 at risk

Adverse event: Shoulder/Neck Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 per DAIDS criteria.
Frequency: 1 affected / 28 at risk