Study: NCT01362959

Adverse event: Death due to respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure, hypoxaemia
Frequency: 1 affected / 21 at risk

Adverse event: Death due to hypercapnic coma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypercarbia due to type II respiratory failure
Frequency: 1 affected / 21 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Blood in the thoracic cavity
Frequency: 1 affected / 21 at risk

Adverse event: Reintubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Need for reintubation after extubation
Frequency: 1 affected / 21 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Investigations
Notes: Any type of electrolyte distubance
Frequency: 21 affected / 21 at risk

Adverse event: Gastrointestinal event
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any type of gastrointestinal upset
Frequency: 21 affected / 21 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: Any type of cardiac or circulatory event
Frequency: 16 affected / 21 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any type of pulmonary event
Frequency: 5 affected / 21 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Notes: Any type of renal disorder
Frequency: 1 affected / 21 at risk

Adverse event: Other adverse events
Serious: no
Organ System: General disorders
Notes: Any other type of adverse event
Frequency: 17 affected / 21 at risk

Adverse event: Death due to respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory failure, hypoxaemia
Frequency: 2 affected / 26 at risk

Adverse event: Reintubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Need for reintubation after extubation
Frequency: 2 affected / 26 at risk

Adverse event: Death due to septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Respiratory sepsis, leading to death
Frequency: 1 affected / 26 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Notes: Shock due to severe hemorrhage
Frequency: 1 affected / 26 at risk

Adverse event: Stoma necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Necrosis of colostoma
Frequency: 1 affected / 26 at risk

Adverse event: Duodenal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Perforation of duodenum
Frequency: 1 affected / 26 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ischaemic disease of colon
Frequency: 2 affected / 26 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Absence of cardiac rhythm
Frequency: 1 affected / 26 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Investigations
Notes: Any type of electrolyte distubance
Frequency: 26 affected / 26 at risk

Adverse event: Gastrointestinal event
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any type of gastrointestinal upset
Frequency: 26 affected / 26 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: Any type of cardiac or circulatory event
Frequency: 26 affected / 26 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Any type of pulmonary event
Frequency: 8 affected / 26 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Notes: Any type of renal disorder
Frequency: 6 affected / 26 at risk

Adverse event: Other adverse events
Serious: no
Organ System: General disorders
Notes: Any other type of adverse event
Frequency: 26 affected / 26 at risk