Skip to main content

Advertisement

Table 2 List of adverse events (AEs)

From: Translation of TRO40303 from myocardial infarction models to demonstration of safety and tolerance in a randomized Phase I trial

  Administration Description Relationship Intensity
Non emergent AEs (before product initiation) 0.5 mg/kg; 0.04 mL/min 1 episode of headache Non applicable Moderate
0.5 mg/kg; 0.08 mL/min 1 episode of headache Non applicable Moderate
13 mg/kg; 10 mL/min 1 episode of headache Non applicable Moderate
1 episode of catheter site pain
Emergent AEs (after product initiation) Placebo 2 episodes of headache 1 Unlikely, 1 Possible Mild
1 episode of myoclonus Possible
1 episode of chest pain Unlikely
0.5 mg/kg; 0.08 mL/min 2 episodes of back pain Excluded 1 Moderate and 1 Mild
2 mg/kg; 0.64 mL/min 1 episode of injection site haematoma Excluded Moderate
3.5 mg/kg; 5 mL/min 1 episode of presyncope Unlikely Moderate
6 mg/kg; 7.5 mL/min 1 episode of infusion site inflammation Probable Moderate
6 mg/kg; 23 mL/min 1 episode of vision blurred Possible Moderate