Table 2.
Adverse event (age) | Therapy at time of AE | Event details |
---|---|---|
Hemothoraxa (57 years) |
RAM, ERL | Event start: day 74 (28 days after last dose of RAM); 5 days after thoracic drainage for pleural empyema |
Renal failure (66 years) |
ERL | Event start: day 846 (202 days after last dose of RAM); medical history: bilateral hydronephrosis |
Pneumonia (74 years) |
ERL | Event start: day 483 (454 days after last dose of RAM); medical history: ex-smoker and VATS partial lung resection |
Pneumonia bacterial (65 years) |
ERL | Event start: day 318 (141 days after last dose of RAM; 5 days after last dose of ERL); medical history: ex-smoker, COPD, recurrent pneumothorax, bulla ligation, lung infections |
Encephalitis influenza (59 years) |
RAM, ERL | Event start: day 9 (9 days after one dose of RAM); confirmed on microbiological testing |
Lymphoma (53 years) |
RAM, ERL | Event start: day 80 of treatment; non-biopsy proven: small intestinal lymphoma following abdominal CT scan for melena; discontinued all study treatments because of progressive lung cancer day 92; died day 97 |
COPD chronic obstructive pulmonary disease, CT computed tomography, ERL erlotinib, RAM ramucirumab, VATS video-assisted thorascopic surgery
aInvestigator assessed as related to RAM; others not considered related to either study drug