Table 2 Hepatic Events During 12-Week Follow-up Period by Cohort (Full Analysis Set)
Variable | Methoxyflurane Cohort (1) (N = 1236) | Concurrent Cohort (2) (N = 1101) | Non-concurrent Cohort (3) (N = 45112) | p-value (1) vs. (2) | p-value (1) vs. (3) |
|---|---|---|---|---|---|
All Hepatic Events | |||||
No. of patients with events | 23 | 33 | 1112 | - | - |
% of patients (95% CI) | 1.9 (1.1, 2.6) | 3.0 (2.0, 4.0) | 2.5 (2.3, 2.6) | 0.079 | 0.192 |
Incidence Rate for All Hepatic Events | |||||
No. of valid patientsa | 1222 | 1048 | 45112 | - | - |
No. of patients with events (%) | 22 (1.80) | 32 (3.05) | 1112 (2.46) | - | - |
Incidence rate (patient-month) (95% CI) | 6.62 (4.15, 10.03) | 11.34 (7.75, 16.00) | 9.16 (8.63, 9.72) | 0.052 | 0.131 |
Incidence rate ratiob (95% CI) | - | 1.71 (0.99, 2.95) | 1.40 (0.91, 2.11) | - | - |
Confirmed Hepatic Events | |||||
No. of patients with events | 20 | 23 | 287 | - | - |
% of patients (95% CI) | 1.6 (0.9, 2.3) | 2.1 (1.2, 2.9) | 0.6 (0.6, 0.7) | 0.442 | < 0.001 |
Incidence Rate for Confirmed Hepatic Events | |||||
No. of valid patientsa | 1223 | 1049 | 45112 | - | - |
No. of patients with events (%) | 20 (1.64) | 23 (2.19) | 287 (0.64) | - | - |
Incidence rate (patient-month) (95% CI) | 6.01 (3.67, 9.28) | 8.08 (5.12, 12.13) | 2.33 (2.07, 2.62) | 0.332 | < 0.001 |
Incidence rate ratiob (95% CI) | - | 1.34 (0.74, 2.45) | 0.39 (0.25, 0.61) | - | - |