Table 2 List of adverse events (AEs)

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