Study: NCT00974493

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: General disorders
Notes: Adverse Event data were not available for 8 participants in relation to C difficile and Line Complication. For events collected by non-systematic methods, data are reported with reference to organ system rather than specific adverse event term
Frequency: 138 affected / 527 at risk

Adverse event: C difficile
Serious: yes
Organ System: Infections and infestations
Notes: C difficile was reported as a defined secondary outcome. No data available from 4 participants in each arm
Frequency: 5 affected / 523 at risk

Adverse event: Line complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Line complications were reported as a defined secondary outcome. No data available from 4 participants in each arm
Frequency: 5 affected / 523 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 527 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 527 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 527 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 527 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 527 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 10 affected / 527 at risk

Adverse event: Neoplastic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 527 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 527 at risk

Adverse event: Skin and soft tissue unrelated to original surgical site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 527 at risk

Adverse event: Related to the operative site
Serious: no
Organ System: General disorders
Notes: Includes directed specialist care for symptom control, wound management, mobility, skin and soft tissue infection, dislocation or recurrent primary endpoint
Frequency: 69 affected / 527 at risk

Adverse event: Antibiotic related
Serious: no
Organ System: General disorders
Notes: Antibiotic related events represented here were attributed by the responsible infection specialist to antibiotic therapy (as opposed to unrelated co-morbidities).
Frequency: 15 affected / 527 at risk

Adverse event: Frailty related
Serious: no
Organ System: General disorders
Notes: Frailty related events included slips, trips or falls in the elderly or readmission as a result of inability to cope at home
Frequency: 5 affected / 527 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: General disorders
Notes: Adverse Event data were not available for 8 participants in relation to C difficile and Line Complication. For events collected by non-systematic methods, data are reported with reference to organ system rather than specific adverse event term
Frequency: 146 affected / 527 at risk

Adverse event: C difficile
Serious: yes
Organ System: Infections and infestations
Notes: C difficile was reported as a defined secondary outcome. No data available from 4 participants in each arm
Frequency: 9 affected / 523 at risk

Adverse event: Line complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Line complications were reported as a defined secondary outcome. No data available from 4 participants in each arm
Frequency: 49 affected / 523 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 527 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 527 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 527 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 527 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 527 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 527 at risk

Adverse event: Neoplastic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 527 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 527 at risk

Adverse event: Skin and soft tissue unrelated to original surgical site
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 527 at risk

Adverse event: Related to the operative site
Serious: no
Organ System: General disorders
Notes: Includes directed specialist care for symptom control, wound management, mobility, skin and soft tissue infection, dislocation or recurrent primary endpoint
Frequency: 46 affected / 527 at risk

Adverse event: Antibiotic related
Serious: no
Organ System: General disorders
Notes: Antibiotic related events represented here were attributed by the responsible infection specialist to antibiotic therapy (as opposed to unrelated co-morbidities).
Frequency: 30 affected / 527 at risk

Adverse event: Frailty related
Serious: no
Organ System: General disorders
Notes: Frailty related events included slips, trips or falls in the elderly or readmission as a result of inability to cope at home
Frequency: 10 affected / 527 at risk