2. Adverse events.
| Study | Number of children/total number in group (%) experiencing ≥ 1 adverse event | Number of children/total number in group (%) experiencing ≥ 1 adverse event judged by study investigators to be serious in nature | Number of participants/total number in group (%) experiencing ≥ 1 adverse event judged by study investigators to be related to study drug | Narrative results provided by the study investigators | |||
| Immunoglobulin | Placebo | Immunoglobulin | Placebo | Immunoglobulin | Placebo | ||
| Lagos 2009 | 11/16 (69) | 6/15 (40) | 1/16 (6) | 1/15 (7) | 0 | 0 | "The frequency of AEs was similar between the combined motavizumab groups and the placebo group" (p. 836) |
| Ramilo 2014 | 60/76 (79) | 33/37 (89) | 13/76 (17) | 6/37 (16) | 6/76 (8) | 4/37 (11) | "The incidence rates of AEs and SAEs were similar for the 3 groups" (p. 706) |
| Rodriguez 1997a | 16/51 (31) | 10/51 (20) | NA | NA | 16 of 22 adverse events among the 16 immunoglobulin participants experiencing ≥ 1 adverse event and 8 of 11 adverse events among 10 placebo participants experiencing ≥ 1 adverse event were judged to be related to study drug. | "No significant differences in adverse events were reported in the RSVIG group... when compared with the control group" (p. 454) | |
| Malley 1998 | NA | NA | 7/17 (41) | 6/18 (33) | 0 | 0 | "The percentage of children reporting adverse events and the total number of adverse events were similar in the placebo and MEDI0493 groups" (p. 1559) |
| Sáez‐Llorens 2004 | NA | NA | 7/30 (23) | 7/29 (24) | 1/30 (3) | 3/30 (10) | "The incidence of individual adverse events was balanced between the placebo and palivizumab treatment groups for each dose" (p. 710) |
AE: adverse event, NA: not available, RSVIG: respiratory syncytial virus immunoglobulin, SAE: serious adverse event