The median (and range) numbers of adjuvant cycles completed in Arms 1, 2 and 4 were 9 (112), 10 (112) and 7 (112), respectively. a The denominator includes patients from the safety population. b The reasons for not having surgery (and the number of patients for each reason) were as follows: AE, 1 (grade 3 renal infarct); PD, 2; study discontinuation, 1; death, 1 (intestinal ischemia and septic shock). c The reasons for not having surgery (and the number of patients for each reason) were as follows: AE, 2 (1 patient experienced grade 4 mediastinal abscess; 1 patient experienced grade 3 syncope); investigator or patient decision, 3. d The reasons for not having surgery (and the number of patients for each reason) were as follows: investigator or patient decision, 3. e Surgical margins are calculated for patients who completed surgery. f The reasons for discontinuation of study treatment (and the number of patients for each reason) were as follows: AE, 3; PD, 6; other, 3. g The reasons for discontinuation of study treatment (and the number of patients for each reason) were as follows: AE, 5; PD, 4; other, 2. h The reasons for discontinuation of study treatment (and the number of patients for each reason) were as follows: AE, 2; PD, 3; other, 3. i The reasons for not starting adjuvant therapy after receiving surgery (and the number of patients for each reason) were as follows. In Arm 1: AE, 3 (1 patient each owing to grade 3 empyema, grade 3 pneumonia and grade 2 asthenia); PD, 3; investigator or patient decision, 4; death, 2 (1 due to pneumonia and 1 due to atrial fibrillation). In Arm 2: AE, 5 (1 each owing to grade 3 psoriasis, grade 3 anaphylaxis and grade 3 eczema; 1 owing to grade 2 arthralgia and grade 2 asthenia; 1 owing to grade 2 renal disorder, grade 2 rash, grade 2 alanine aminotransferase (ALT) increase, grade 4 neutrophil count decrease and grade 2 C-reactive protein increase); PD, 1; patient decision, 2; death, 3 (1 due to sepsis, 1 due to septic shock and 1 due to postoperative renal failure); other, 2. In Arm 4: AE, 1 (grade 2 colitis); death, 1 (Idiopathic pulmonary fibrosis); other, 2. n = 202 randomized patients, n = 199 patients in the safety population and n = 198 in mITT population. PD, progressive disease.
