0 (4.2) 4.6 (4.5) 4.3 (4.3)  Median 2.9 3.4 3.2  Range 0.2–22.9 0.2–23.6 0.2–23.6 Gestational age (weeks)  Mean (SD) 32.7 (2.5) 32.4 (2.7) 32.5

(2.6)  Median 34.0 33.0 34.0  Range 24–36 24–38 24–38 Gender, n (%)  Male 103 (51.0) 107 (50.7) 210 (50.8) Race, n (%)  White/non-Hispanic 149 (73.8) 151 (71.6) 300 (72.6)  Black 24 (11.9) 25 (11.8) 49 (11.9)  Hispanic 14 (6.9) 22 (10.4) 36 (8.7)  Asian 3 (1.5) 1 (0.5) 4 (1.0)  Other 12 (5.9) 12 (5.7) 24 (5.8) Weight at day 0 (kg)  Mean (SD) 5.1 (2.3) 5.3 (2.3) 5.2 (2.3)  Median 4.74 5.20 5.00  Range 1.8–13.8 1.8–14.5 1.8–14.5 CLD of prematurity, n (%)  Yes 26 (12.9) 35 (16.6) 61 (14.8) CLD Chronic lung disease, SD standard deviation Safety The majority of subjects in both study groups selleck chemical received all 5 doses of medication [94.8% (200/211) in the liquid palivizumab group and 95%

(192/202) in the lyophilized palivizumab group]. The SHP099 incidence of SAEs reported was 8.5% (18/211) with liquid palivizumab and 5.9% (12/202) with lyophilized palivizumab (Table 2). One subject in the lyophilized palivizumab group died of asphyxia Abemaciclib datasheet next during the study, but the death was deemed not related to the study medication by the study investigator. None of the SAEs were determined by the investigators to be related to study medication. Table 2 Serious adverse events SAE, n (%) Lyophilized palivizumab (n = 202) Liquid palivizumab (n = 211) Total (n = 413) Total number of subjects reporting ≥1 SAE 12 (5.9) 18 (8.5) 30 (7.3) Bronchiolitis 3 (1.5) 6 (2.8) 9 (2.2) Gastroenteritis 2 (1.0) 2 (0.9) 4 (1.0) Respiratory distress 2 (1.0) 0 (0.0) 2 (0.5) Viral infection 0 (0.0) 2 (0.9) 2 (0.5) Cleft lip 1 (0.5) 1 (0.5) 2 (0.5)

Inguinal hernia 1 (0.5) 1 (0.5) 2 (0.5) Abscess 1 (0.5) 0 (0.0) 1 (0.2) Anal fissure 0 (0.0) 1 (0.5) 1 (0.2) Apnea 1 (0.5) 0 (0.0) 1 (0.2) Asphyxia 1 (0.5) 0 (0.0) 1 (0.2) Bronchopneumonia 0 (0.0) 1 (0.5) 1 (0.2) Cellulitis 0 (0.0) 1 (0.5) 1 (0.2) Complex partial seizures 0 (0.0) 1 (0.5) 1 (0.2) Convulsions 0 (0.0) 1 (0.5) 1 (0.2) Craniosynostosis 0 (0.0) 1 (0.5) 1 (0.2) Dehydration 0 (0.0) 1 (0.5) 1 (0.2) Dyspnea 1 (0.5) 0 (0.0) 1 (0.2) Failure to thrive 1 (0.5) 0 (0.0) 1 (0.2) Gastroenteritis rotavirus 0 (0.0) 1 (0.5) 1 (0.2) Gastroesophageal reflux disease 0 (0.0) 1 (0.5) 1 (0.2) Hydronephrosis 0 (0.0) 1 (0.5) 1 (0.2) Infectious croup 0 (0.0) 1 (0.5) 1 (0.2) Lymphadenitis 0 (0.0) 1 (0.5) 1 (0.2) Occult blood positive 1 (0.5) 0 (0.0) 1 (0.2) Umbilical hernia 0 (0.0) 1 (0.5) 1 (0.