Study: NCT00604695

Adverse event: Erosive Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause of death unknown.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pre-existing anemia.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Pre-existing chronic pancreatitis.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding at the site of insertion of catheter.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 5 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: High grade Atrio-Ventricular Block
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 20 at risk

Adverse event: Dressler's syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Right hand and finger numbness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Primary percutaneous coronary intervention was performed via radial approach.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Right groin cellulitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pre-existing asthma.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Allergic reaction to Bactrim
Serious: no
Organ System: Immune system disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Allergic reaction to Lisinopril
Serious: no
Organ System: Immune system disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Bleeding at the site of insertion of catheter.

Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 2 affected / 16 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk

Adverse event: High grade Atrio-Ventricular Block
Serious: no
Organ System: Cardiac disorders
Notes: Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).
Frequency: 1 affected / 16 at risk