Analysis population |

Changed set of patients included by specifying additional exclusions | 12 (13%) |

Analysis model |

Changed model | 13 (15%) |

Changed method of selecting analysis model | 2 (2%) |

Covariates |

Changed from unadjusted to adjusted analysis | 7 (8%) |

Changed from adjusted to unadjusted analysis | 4 (4%) |

Changed set of covariates included in analysis | 5 (6%) |

Missing data |

Changed from complete case to multiple imputation | 1 (1%) |

Changed imputation strategy | 2 (2%) |

Unexplained additions |

Analysis population |

Not mentioned in the original analysis plan | 8 (9%) |

Incomplete detail given in the original analysis plan | 7 (8%) |

Allowed analyst to subjectively choose analysis population based on the trial dataset | 1 (1%) |

Analysis model |

Not mentioned in the original analysis plan | 5 (6%) |

Incomplete detail given in the original analysis plan | 5 (6%) |

Allowed analyst to subjectively choose analysis model based on the trial dataset | 7 (8%) |

Covariates |

Not mentioned in the original analysis plan | 2 (2%) |

Incomplete detail given in the original analysis plan | 2 (2%) |

Allowed analyst to subjectively choose covariates based on the trial dataset | 3 (3%) |

Missing data |

Not mentioned in the original analysis plan | 9 (10%) |

Incomplete detail given in the original analysis plan | 3 (3%) |

Allowed analyst to subjectively choose missing data approach based on the trial dataset | 1 (1%) |