Table 2.
Classification of reasons for treatment change used in the SANAD trial
| Reason for withdrawal from drug or other drug added (earliest event) | Categorised as event (type classified as ISC or UAE) or censored in 'time to treatment failure' analysis | Number of patients (CBZ, LTG, TPM and GBP) |
| Inadequate seizure control | Event (ISC) | 348 |
| Unacceptable adverse events | Event (UAE) | 320 |
| Perceived risk of adverse effect | Event (UAE) | 8 |
| Remission of epilepsy categorised by patient1 (less than 12 months' remission from seizures) | Event (UAE) | 46 |
| Remission of epilepsy categorised by clinician (any length) or patient (more than 12 months' remission from seizures) | Censored | 88 |
| Study withdrawal – consent withdrawn2 | Censored | 23 |
| Death (unrelated to epilepsy)3 | Censored | 32 |
| Death (related to epilepsy)3 | Event (ISC) | 3 |
| Moved from area | Censored | 0 |
| Patient non-compliant or patient decision4 | Censored | 12 |
| Pregnant or planning pregnancy | Censored | 6 |
| Other | Censored | 12 |
| Still on drug at last follow-up | Censored | 597 |
| Not epilepsy | Excluded | 16 |
1 Patients decision to withdraw before 12 months' freedom from seizures is likely to be highly influenced by side effects or perception of side effects
2 Study withdrawals are automatically checked to ensure that the patient wants to withdraw from study rather than from drug only
3 Blinded assessment to identify whether death is related or unrelated to epilepsy/AED to take place prior to analysis
4 Further information is sought if patient withdraws from drug due to "non-compliance" as the underlying reason could be unacceptable adverse events, inadequate seizure control or remission of epilepsy.