Table 2 Incidence density rates of hypersensitivity reactions within 42 days of abacavir initiation, by screening period
Adjudicated hypersensitivity reaction definition | Screening period | Hypersensitivity reaction events | Person-days on abacavir | Incidence rate per 100,000 person-days (95% CI) | Post- vs. pre-screening incidence rate ratio (95% CI) |
|---|---|---|---|---|---|
Any hypersensitivity reactiona | Pre-screeningb | 51 | 129,856 | 39 (30, 52) | 1.00 (Ref) |
Post-screeningc | 37 | 232,905 | 16 (12, 22) | 0.36 (0.23, 0.55) | |
Definitive/probable hypersensitivity reactiond | Pre-screeningb | 42 | 129,856 | 32 (23, 44) | 1.00 (Ref) |
Post-screeningc | 27 | 232,905 | 12 (8, 17) | 0.31 (0.19, 0.52) |