Table 2.
Clinical outcomes
| Endpoint | Patients with Events, No. (%) Degarelix vs. Leuprolide |
HR (95% CI)* | P-value† |
|---|---|---|---|
| Primary efficacy | |||
| Time from randomization to first adjudicated MACE | 15 (5.5%) vs. 11 (4.1%) | 1.283 (0.589–2.794) | 0.5294 |
| Sensitivity of primary efficacy | |||
| Time from randomization to first adjudicated MI, stroke, unstable angina requiring hospitalization, or all-cause death | 17 (6.2%) vs. 15 (5.6%) | 1.065 (0.532–2.134) | 0.8580 |
| Total occurrences of adjudicated MI, stroke, and all-cause death‡ | 21 vs. 17‡ | 1.265 (0.515–3.107) | 0.6076 |
| Time from randomization to first MACE-related AE according to broad SMQ | 14 (5.1%) vs. 20 (7.4%) | 0.665 (0.336–1.317) | 0.2389 |
| Time from randomization to first adjudicated occurrence of MACE (not censored at treatment discontinuation or change of ADT regimen) | 15 (5.5%) vs. 11 (4.1%) | 1.319 (0.606–2.873) | 0.4835 |
| Time from randomization to first adjudicated MACE over full trial duration# | 17 (6.2%) vs. 12 (4.5%) | 1.446 (0.677–3.088) | 0.3382 |
| Time from randomization to the first adjudicated MACE (using all CEC adjudicated events) | 18 (6.5%) vs. 13 (4.8%) | 1.468 (0.707–3.051) | 0.3003 |
| Key secondary efficacy§ | |||
| Time from randomization to first adjudicated occurrence of CV-related death, non-fatal MI, or non-fatal stroke | 9 (3.3%) vs. 7 (2.6%) | 1.204 (0.448–3.234) | 0.7126 |
| Time from randomization to first adjudicated CV-related death | 1 (0.4%) vs. 5 (1.9%) | 0.186 (0.022–1.595) | 0.0853 |
| Endpoints for MACE components | |||
| Time from randomization to first adjudicated MI | 5 (1.8%) vs. 3 (1.1%) | 1.594 (0.381–6.673) | 0.5196 |
| Time from randomization to first adjudicated stroke | 3 (1.1%) vs. 3 (1.1%) | 0.899 (0.181–4.457) | 0.8964 |
| Time from randomization to all-cause death | 8 (2.9%) vs. 9 (3.3%) | 0.839 (0.324–2.176) | 0.7184 |
Hazard ratio and 95 percent confidence interval for degarelix versus leuprolide are estimated using a Cox regression stratified for age group and region.
p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.
For the total number of MACE, the occurrence rate ratio is presented along with a 95% confidence interval and the corresponding p-value derived from a negative binomial regression.
Endpoints controlled for multiplicity by a closed testing sequence. Formally, by this procedure and endpoint is only statistically significant if all previous endpoints are having a p-value below 0.05, ordered from top to bottom.
Over full trial duration indicates that this endpoint was not censored at day 336 and events occurring after 336 and before the end-of-study visit were included.
ADT indicates androgen deprivation therapy; CEC, clinical events committee; CI, confidence interval; CV, cardiovascular; HR, hazard ratio; MACE, major adverse cardiovascular events; MI, myocardial infarction; SMQ, Standardized MedDRA Queries.