Study: NCT01446965

Adverse event: CHD hospitalization, 1st event post-randomization
Serious: yes
Organ System: Cardiac disorders
Frequency: 475 affected / 1524 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 510 affected / 1524 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 283 affected / 1524 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 551 affected / 1524 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 344 affected / 1524 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 59 affected / 1524 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 132 affected / 1524 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 259 affected / 1524 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 327 affected / 1524 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 265 affected / 1524 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 548 affected / 1524 at risk

Adverse event: Rash in any location
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 216 affected / 1524 at risk

Adverse event: Rash on torso
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 184 affected / 1524 at risk

Adverse event: Itch in any location
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 243 affected / 1524 at risk

Adverse event: Itch on torso
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 205 affected / 1524 at risk

Adverse event: CHD hospitalization, 1st event post-randomization
Serious: yes
Organ System: Cardiac disorders
Frequency: 253 affected / 778 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 274 affected / 778 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 137 affected / 778 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: General disorders
Frequency: 264 affected / 778 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 166 affected / 778 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 36 affected / 778 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 778 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 136 affected / 778 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 182 affected / 778 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 151 affected / 778 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 321 affected / 778 at risk

Adverse event: Rash in any location
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 778 at risk

Adverse event: Rash on torso
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 778 at risk

Adverse event: Itch in any location
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 778 at risk

Adverse event: Itch on torso
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 778 at risk