Table 2 Summary of adverse events

From: Intranasal monoclonal antibodies do not prevent respiratory infection in a randomized, controlled experimental infection trial

 

Palivizumab (n = 14)

Placebo (n = 14)

Adverse events

1 (7.1%)

2 (14.3%)

Participants with AEs

1 (7.1%)

2 (14.3%)

Participants with grade 1 AEs

1 (7.1%)

2 (14.3%)

Participants with serious AEs

0 (0%)

0 (0%)

Participants with ≥1 AE possibly related to the trial regimen

1 (7.1%)

2 (14.3%)

Participants with ≥1 AE possibly related to RSV challenge

1 (7.1%)

0 (0%)

  1. Data are in n (%). Number of participants who experienced adverse events during study follow-up, as self-reported, when asked about any adverse events as part of a daily checklist during household visits, or as observed by study personnel. Symptoms included in the symptom diary were presumed to represent virus infection consequent to RSV challenge and not regarded as AE unless they met the definition of an AE (Supplementary Materials). Grading scale: Grade 1 = mild (awareness of a symptom but the symptom is easily tolerated); grade 2 = moderate (discomfort enough to cause interference with usual activity); grade 3 = severe (incapacitating; unable to perform usual activities; requires absenteeism from work or bed rest). AE adverse event.
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