An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series three patients (1 man and 2 women) aged 62−72 years were described, who developed arteritis during prophylactic treatment with pegfilgrastim [dosages not stated].
Case 1: The 69-year-old man had underlying follicular lymphoma, stage IIIB associated with a bulky mass on the abdomen. He had received R-CHOP therapy comprising IV rituximab 375 mg/m2 on cycle day 1, IV cyclophosphamide 750 mg/m2, IV doxorubicin 50 mg/m2, IV vincristine 1.4 mg/m2 on cycle day 2, and IV prednisone 60 mg/m2on day 2 followed by oral prednisone from day 3−6 of each cycle. However, his cancer relapsed (biopsy-proven) after 5 years, showing transformation to diffuse large B-cell lymphoma in the pharynx. He then started receiving salvage chemotherapy with R-modified ESHAP regimen,...