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Table 2 Frequency of adverse events grade ≥ 3, reported in ≥ 2 (4 %) of patients of either group regardless of causality

From: Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program

Adverse events Sunitinib plus FOLFIRIa Placebo plus FOLFIRIa
N = 45 100 % N = 45 100 %
Neutropenia 25 56 9 20
Leucopenia 12 27 7 16
Diarrhea 1 2 6 13
Nausea 3 7 3 7
Vomiting 3 7 3 7
Fatigue - - 4 9
Pain - - 4 9
Pulmonary embolism 2 4 2 4
General physical health deterioration 2 4 2 4
Mucosal inflammation 2 4 2 4
Gamma-glutamyltransferase increased 3 7 1 2
Pneumonia - - 3 7
Subileus - - 3 7
Blood acid phosphatase increased 2 4 - -
Blood bilirubin increased 2 4 - -
  1. FOLFIRI 5-fluorouracil, leucovorin and irinotecan
  2. aSchedule: 4/2, 4 weeks on treatment, followed by 2 weeks off; dosage: starting dose 25 mg/day
  3. Neutropenia: p < 0.001, leucopenia p = 0.20, all other items statistically not significant (Fisher’s exact test)