| Total | Severity | Action taken | Outcome |
---|---|---|---|---|
Patients with IRRs, n (%) | 3 (10) | Â | Â | Â |
IRRs, n | 5 | Â | Â | Â |
Erythema | 1 | Moderate | Dose reduced | Resolved |
Pyrexia | 1 | Mild | No change | Resolved |
Swelling of eyelid | 1 | Mild | No change | Resolved |
Tachycardia | 1 | Moderate | Dose reduced | Resolved |
Vomiting | 1 | Moderate | Drug withdrawn | Resolved |
Patients with serious IRRs, n (%) | 1 (3) | Â | Â | Â |
Vomiting | 1 | Â | Drug withdrawn | Resolved |