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Table 3 Adverse Events (Safety Population)

From: Safety and efficacy of afatinib as add-on to standard therapy of gemcitabine/cisplatin in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, phase I trial with an extensive biomarker program

   Dose level 1   Dose level − 1   Total   
  Number of Patients with... (N = 3)   nEvents (N = 6)   nEvents (N = 9)   nEvents
  at least one AE 3 (100.00%) 141 6 (100.00%) 247 9 (100.00%) 388
  SAEs 2 (66.67%) 6 5 (83.33%) 13 7 (77.78%) 19
  Related AEs 3 (100.00%) 102 6 (100.00%) 137 9 (100.00%) 239
  AEs leading to premature study discontinuation 0 (0.00%) 0 1 (16.67%) 1 1 (11.11%) 1
  AEs leading to death 1 (33.33%) 2 1 (16.67%) 1 2 (22.22%) 3