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. 2021 Dec 20;45(1):45–64. doi: 10.1007/s40264-021-01127-2

Table 2.

Deaths due to adverse events while receiving study treatment or within 30 days of all study treatment discontinuation

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