Background
All-cause or cause-specific mortality?
Lower power for all-cause mortality
Cause of death | Postpartum haemorrhage | Gastrointestinal haemorrhage | Traumatic haemorrhageb | |||
---|---|---|---|---|---|---|
N = 20,021 | N = 8,699 | N = 20,127 | ||||
n (%) | Days (hours) | n (%) | Days (hours) | n (%) | Days (hours) | |
Bleeding | 346 (1.7) | 0 (5) | 350 (4.0) | 1 (28) | 1063 (5.3) | 0 (10) |
Thrombosisa | 21 (0.1) | 0 (11) | 32 (0.4) | 4 (94) | 81 (0.4) | 4 (88) |
Organ failure | 43 (0.2) | 2 (47) | 141 (1.6) | 5 (127) | 486 (2.4) | 3 (83) |
Sepsis | 23 (0.1) | 5 (118) | 109 (1.3) | 6 (140) | 44 (0.2) | 9 (219) |
Other | 50 (0.2) | 1 (13) | 182 (2.1) | 5 (114) | 1402 (7.0) | 1 (35) |
All-cause | 483 (2.4) | 0 (7) | 814 (9.4) | 3 (66) | 3076 (15.3) | 1 (22) |
Important safety signals may be obscured in all-cause mortality
Generalisability
Cause/time of death | Postpartum haemorrhage | Traumatic haemorrhageb | All | |||
---|---|---|---|---|---|---|
(N = 14,923) | (N = 13,484) | (N = 28,407) | ||||
RR (95% CI) | p value | RR (95% CI) | p value | RR (95% CI) | p value | |
All-cause | 0.83 (0.66–1.04) | 0.099 | 0.87 (0.80–0.94) | < 0.001 | 0.86 (0.80–0.93) | < 0.001 |
Cause-specific | ||||||
Haemorrhage | 0.69 (0.53–0.90) | 0.007 | 0.72 (0.63–0.83) | < 0.001 | 0.72 (0.63–0.81) | < 0.001 |
Thrombosisa | 1.15 (0.39–3.42) | 0.803 | 0.56 (0.31–0.99) | 0.043 | 0.65 (0.39–1.07) | 0.090 |
Other | 1.35 (0.84–2.15) | 0.213 | 0.99 (0.89–1.10) | 0.867 | 1.01 (0.90–1.12) | 0.908 |
Time-specific (hours from randomisation) | ||||||
< 48 | 0.74 (0.58–0.95) | 0.015 | 0.83 (0.75–0.91) | < 0.001 | 0.81 (0.74–0.89) | < 0.001 |
≥ 48 | 1.81 (0.92–3.55) | 0.080 | 0.94 (0.81–1.10) | 0.457 | 0.98 (0.85–1.15) | 0.844 |