- 19 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, four patients (3 women and 1 man) aged between 44−88 years were described, who developed shortness of breath, hypoxia or chest tightness following administration of brigatinib for adenocarcinoma of lung or non-small cell lung cancer (NSCLC) [routes not stated].
Case 1: A 60-year-old non-smoker woman was diagnosed with Stage IV ALK-positive lung adenocarcinoma with metastases to the mediastinum and bones. She was treated with crizotinib and showed a partial response. After 13 months and 19 months, oligoprogression was noted in the bone metastasis, which were treated with ablative radiotherapy. Crizotinib was continued. Six months following the last bone progression, she was hospitalised due to worsening shortness of breath. Significant changes were noted in her...