Figure 1

Patient disposition from randomization to study completion. *One patient randomized in error received no chemotherapy and no study medication and was excluded from all statistical analyses and populations. ^†Two patients who received chemotherapy but died after randomization, before study medication was administered, were included in the efficacy population but not in the safety population. ^‡Adverse events listed as the primary reason for study discontinuation include placebo patients: two patients each with febrile neutropenia, cerebral infarction, and pneumonia; one patient each with back pain, general physical health deterioration, arterial thrombosis in a limb, pain in the extremities, inadequate control of diabetes mellitus, tumor lysis syndrome, and neutropenia; and one patient with anemia, thrombocytopenia, and neutropenia; lipegfilgrastim patients: two patients with anemia; one patient each with wound necrosis, syphilis, atrial fibrillation, pyothorax, fatigue, increased aspartate aminotransferase, gastric hemorrhage, dementia, pulmonary embolism, asthenia, and hemoptysis. ^§Includes patients lost to follow-up (n = 2), treatment failure (n = 3), and other (n = 5). AE adverse event, ITT intent to treat, PD progression of underlying disease.