Study: NCT02250664

Adverse event: Sudden onset of chest pain due to not enough blood going to the heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 254 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 254 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 3 affected / 254 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 254 at risk

Adverse event: Tenosynovitis of the Hand
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 254 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 2 affected / 254 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 254 at risk

Adverse event: High blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 254 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 254 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 58 affected / 254 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 89 affected / 254 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 254 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 254 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 254 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 78 affected / 254 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 23 affected / 254 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 254 at risk

Adverse event: Sudden onset of chest pain due to not enough blood going to the heart
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 235 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 235 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 235 at risk

Adverse event: Skin graft to wound on leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 235 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 235 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 46 affected / 235 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 235 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 235 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 235 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 235 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 72 affected / 235 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 16 affected / 235 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 235 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 286 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 286 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 2 affected / 286 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 286 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 286 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 3 affected / 286 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 2 affected / 286 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 1 affected / 286 at risk

Adverse event: High blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 286 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 286 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 67 affected / 286 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 92 affected / 286 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 286 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 286 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 286 at risk

Adverse event: Respiratory, thoracic, and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 84 affected / 286 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 26 affected / 286 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 286 at risk