Table 4.
Results for Serious Hypoglycemic Eventsa.
| Number of patients n/N and groups | Number of patients with at least 1 serious hypoglycemic eventa, number (%)b, P value | Incidence rate of serious hypoglycemic events (per 100 patient months) end of the study (start of the study), P value | Absolute number of serious hypoglycemic events at end of the study (start of the study), P value |
|---|---|---|---|
| LGS | |||
| 41c/46 | 0 (0) | 0 (1.8) | 0 (5) |
| Control group | |||
| 45d/49 | 3 (7)e | 2.2 (2.1) | 6 (6) |
| P = .101f | P = .02g | P nr | |
In the publication, defined as SH (added by LH: with seizure or coma). The definition in the publication exclusively includes hypoglycemic events which fulfilled at least 1 criterion for serious adverse events. For this reason, these hypoglycemic events are defined as serious hypoglycemic events in this report. bThe percentage refers to the number of analyzed patients (n). cFive patients were excluded from the analysis. Four patients revoked their declaration of consent. One patient moved away, 3 patients discontinued the treatment. One additional patient did not show up to the follow-up appointments. dFour patients were excluded from the analysis as they revoked their declaration of consent. One patient moved away, 2 patients discontinued treatment, and 1 patient was dissatisfied with the randomization. ePersonal calculation. fPersonal calculation, absolute exact test (CSZ method, see above). gP value for incidence rate using Poisson regression, exact calculation. Underline, result of asking an author.