Study: NCT01809002

Adverse event: Sickle cell anaemia with crisis - Unrelated
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Acute kidney injury - Unrelated
Serious: yes
Organ System: Renal and urinary disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Staphylococcal bacteraemia - Unrelated
Serious: yes
Organ System: Infections and infestations
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Retroperitonial haemorrhage - Unrelated
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Septic shock - Unrelated
Serious: yes
Organ System: Infections and infestations
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Embolic stroke - Unrelated
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Deep vein thrombosis - Unrelated
Serious: yes
Organ System: Vascular disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory failure - Unrelated
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Leukocytosis - Unrelated
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Malignant hypertension - Unrelated
Serious: yes
Organ System: Vascular disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: COVID-19 - Unrelated
Serious: yes
Organ System: Infections and infestations
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Localized infection - Unrelated
Serious: yes
Organ System: Infections and infestations
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Overdose - Unrelated
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Anticipated risk of a surgical procedure
Frequency: 1 affected / 112 at risk

Adverse event: Cholecystitis - Unrelated
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 112 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 112 at risk

Adverse event: Implant site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 3 affected / 112 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 112 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 112 at risk

Adverse event: Completed suicide - Unrelated
Serious: yes
Organ System: Psychiatric disorders
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 108 at risk

Adverse event: Tendon rupture - Unrelated
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Determined to be Unrelated to treatment
Frequency: 1 affected / 108 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 108 at risk

Adverse event: Implant site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 108 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 108 at risk