Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839.
Any AEs and SAEs occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
Until 30 days after the last dose of trial drug
AstraZeneca Germany Medical Director, MD
Germany: Federal Institute for Drugs and Medical Devices