Multiple drugs
Anaemia, thrombocytopenia, febrile neutropenia, lymphopenia, uveitis, hearing loss, hyponatraemia, infection, atrial fibrillation, tachycardia, transaminitis, hypoxia, rigors, weight gain, hypotension: 17 case reports-
Serious
An event is determined to be serious (based on the ICH definition) when the patient outcome is:
death
life-threatening
hospitalisation
disability
congenital anomaly
other medically important event