Table 3.
SFTM and IPCW results (with fortnightly intervals) for LTG:VPS.
| Estimand | Follow-up time:median (IQR) days |
Number (%) with remission |
Number (%) with treatment change |
IPCW |
|||||
|---|---|---|---|---|---|---|---|---|---|
| LTG (n = 193) | VPS (n = 194) | LTG (n = 193) | VPS (n = 194) | LTG (n = 193) | VPS (n = 194) | TVCs included in WD model | PLR OR (95% CI) | Cox HR (95% CI) | |
| ITT | 385 (365, 646) | 517 (365, 876) | 143 (74%) | 154 (79%) | (No TVCs included in model) | 0.72 (0.57, 0.94) | |||
| (Breslow) | 0.77 (0.61, 0.97) | ||||||||
| (Efron) | 0.73 (0.58, 0.92) | ||||||||
| (Exact partial likelihood) | 0.72 (0.56, 0.93) | ||||||||
| TF3 (PP) | 365 (280, 531) | 365 (365, 483) | 90 (47%) | 114 (59%) | (No TVCs included in model) | 0.65 (0.48, 0.87) | |||
| Breslow | 0.73 (0.58, 0.89) | ||||||||
| Efron | 0.68 (0.52, 0.90) | ||||||||
| (Exact partial likelihood) | 0.65 (0.47, 0.90) | ||||||||
| TF1 | 365 (280, 531) | 365 (365, 483) | 110 (57%) | 141 (73%) | 52 (27%) | 26 (13%) | No TVCs | 0.70 (0.55, 0.996) | |
| (Breslow) | 0.77 (0.64, 1.00) | ||||||||
| (Efron) | 0.73 (0.57, 0.94) | ||||||||
| (Exact partial likelihood) | 0.70 (0.53, 0.94) | ||||||||
| Seizures | 0.68 (0.38, 1.26) | 0.74 (0.42, 3.03) | |||||||
| Seizures and dose | 0.67 (0.37, 1.36) | 0.73 (0.22, 68.63) | |||||||
| Seizures, dose and AEs | 0.66 (0.39, 12.09) | 0.72 (0.29, 120.24) | |||||||
| TF2 | 365 (280, 531) | 365 (365, 483) | 108 (56%) | 139 (72%) | 55 (28%) | 29 (15%) | No TVCs | 0.70 (0.54, 0.99) | |
| (Breslow) | 0.77 (0.60, 0.99) | ||||||||
| (Efron) | 0.73 (0.57, 0.94) | ||||||||
| (Exact partial likelihood) | 0.70 (0.52, 0.94) | ||||||||
| Seizures | 0.68 (0.38, 1.35) | 0.75 (0.37, 3.11) | |||||||
| Seizures and dose | 0.67 (0.34, 3.38) | 0.73 (0.19, 29.71) | |||||||
| Seizures, dose and AEs | 0.66 (0.38, 2.97) | 0.72 (0.21, 102.47) | |||||||
| TF3 | 365 (280, 531) | 365 (365, 483) | 90 (47%) | 114 (59%) | 74 (38%) | 59 (30%) | No TVCs | 0.65 (0.48, 0.87) | |
| (Breslow) | 0.73 (0.58, 0.89) | ||||||||
| (Efron) | 0.68 (0.52, 0.90) | ||||||||
| (Exact partial likelihood) | 0.65 (0.47, 0.90) | ||||||||
| Seizures | 0.61 (0.40, 1.10) | 0.68 (0.53, 1.18) | |||||||
| Seizures and dose | 0.60 (0.40, 1.84) | 0.67 (0.47, 2.99) | |||||||
| Seizures, dose and AEs | 0.59 (0.28, 1.54) | 0.65 (0.26, 2.58) | |||||||
| SFTM |
|||||||||
| AF = (95%CI) |
HR (95% CI) |
||||||||
| Sw3 | 438 (365, 906) | 570 (365, 1162) | 143 (74%) | 154 (79%) | 59 (31%) | 34 (18%) | 0.77 (0.52, 0.999) | 0.76 (0.57, 1.03) | |
| Dir1 | 379 (365, 684) | 365 (365, 485) | 110 (57%) | 119 (61%) | 25 (13%) | 9 (5%) | 0.89 (0.72, 1.000) | 0.73 (0.54, 0.98) | |
| Dir2 | 379 (365, 684) | 365 (365, 485) | 111 (57%) | 121 (62%) | 25 (13%) | 11 (6%) | 0.89 (0.72, 1.000) | 0.72 (0.54, 0.97) | |
| Dir3 | 394 (365, 692) | 365 (365, 496) | 116 (60%) | 129 (66%) | 35 (18%) | 18 (9%) | 0.84 (0.67, 0.999) | 0.68 (0.51, 0.90) | |
IPCW: inverse probability of censoring weighting; IQR: interquartile range; LTG: lamotrigine; VPS: sodium valproate; PLR: pooled logistic regression; OR: odds ratio; HR: hazard ratio; TVC: time-varying covariate; ITT: intention to treat; CI: confidence interval; PP: per protocol; AE: adverse events; SFTM: structural failure time model.