Study: NCT01756833

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 32 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 129 at risk

Adverse event: Frequent joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 84 affected / 129 at risk

Adverse event: Frequent gastric or intestinal upset
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 129 at risk

Adverse event: Frequent bleeding or bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 47 affected / 129 at risk

Adverse event: Frequent spells of dizziness
Serious: no
Organ System: General disorders
Frequency: 34 affected / 129 at risk

Adverse event: Skin rash or hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 129 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 129 at risk

Adverse event: Moderate to severe sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 129 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 27 affected / 129 at risk

Adverse event: Tooth discolouration
Serious: no
Organ System: General disorders
Frequency: 12 affected / 129 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 129 at risk

Adverse event: Other symptom requiring study drug dose adjustment or discontinuation
Serious: no
Organ System: General disorders
Frequency: 27 affected / 129 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 38 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 125 at risk

Adverse event: Serious or Unexpected Adverse Events
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 125 at risk

Adverse event: Frequent joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 125 at risk

Adverse event: Frequent gastric or intestinal upset
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 125 at risk

Adverse event: Frequent bleeding or bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 125 at risk

Adverse event: Frequent spells of dizziness
Serious: no
Organ System: General disorders
Frequency: 37 affected / 125 at risk

Adverse event: Skin rash or hives
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 125 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 43 affected / 125 at risk

Adverse event: Moderate to severe sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 125 at risk

Adverse event: Tooth discolouration
Serious: no
Organ System: General disorders
Frequency: 18 affected / 125 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 125 at risk

Adverse event: Other symptom requiring study drug dose adjustment or discontinuation
Serious: no
Organ System: General disorders
Frequency: 27 affected / 125 at risk