Table 3.
Proportion of participants experiencing at least one grade 3–5 adverse event by 52 weeks that was possibly, probably, or definitely related to study treatment using a modified intention-to-treat analysis for a model based on the raw dataset and imputed dataset
Raw dataset | Imputed dataset | |
---|---|---|
Prednisolone (n/N, %) | 41/113 (36%) | 40·0%* |
Doxycycline (n/N, %) | 22/121 (18%) | 22·5%* |
Adjusted† difference in proportions (%, 95% CI) | 19·0% (7·9–30·1); p=0·001 | 18·4% (6·0–30·8); p=0·004 |
Unadjusted difference in proportions (%, 95% CI) | 18·1% (6·9–29·3); p=0·002 | 17·5% (4·8–30·1); p=0·007 |
Estimates from unadjusted regression model on imputed dataset.
Estimates are from a regression model adjusted for baseline severity of bullous pemphigoid; however, Karnofsky score and age were omitted from the model due to model non-convergence with it present.