CPRD non-interventional population | TORCH trial population^{#} | |||

Unexposed to FP-SAL | Exposed to FP-SAL | Placebo | FP-SAL | |

Subjects | 4196 | 10 463 | 1524 | 1533 |

Exacerbations | ||||

Person-years at risk | 9330 | 22 054 | ||

Events | 4994 | 15 944 | ||

Rate per person per year | 0.53 | 0.72 | 1.13 | 0.85 |

Crude rate ratio | 1 | 1.35 (1.28–1.43) | ||

Propensity matched rate ratio | 1 | 1.30 (1.19–1.42)^{+} | 1 | 0.75 (0.69–0.81) |

Mortality | ||||

Person-years at risk | 9330 | 22 054 | ||

Events | 543 | 1245 | ||

Probability at 3 years^{¶} % | 16.13 | 16.04 | 15.16 | 12.59 |

Crude hazard ratio | 1 | 0.98 (0.88–1.08) | ||

Propensity matched hazard ratio | 1 | 1.11 (0.95–1.26)^{§} | 1 | 0.83 (0.68–1.00) |

Pneumonia | ||||

Events | 350 | 998 | ||

Percentage of total patients | 8.34 | 9.54 | 12.31 | 19.60 |

Crude risk ratio | 1 | 1.14 (1.01–1.28) | ||

Propensity matched risk ratio | 1 | 1.14 (0.96–1.34)^{ƒ} | 1 | 1.59 (1.35–1.88) |

Time to treatment discontinuation | ||||

Person-years at risk | ^{##} | 20 402 | ||

Events | 2255 | |||

Probability at 3 years^{¶} % | 28.20 | 43.50 | 33.70 | |

Crude hazard ratio | ||||

Propensity matched hazard ratio | 1 | 0.69 (0.62–0.78) |

Data are presented as n, unless otherwise stated. CPRD: Clinical Practice Research Datalink. ^{#}: only results reported in the TORCH trial publication are shown; ^{¶}: calculated using a Cox proportional-hazards model; ^{+}: n=2652 in each exposure group after propensity score matching (supplementary table A2-3 for list of variables contributing to propensity score for exacerbations analysis); ^{§}: n=2708 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for mortality analysis); ^{ƒ}: n=2779 in each exposure group after propensity score matching (see supplementary table A2-3 for list of variables contributing to propensity score for pneumonia analysis); ^{##}: time to treatment discontinuation analysis not applicable for unexposed to FP-SAL group.