eted‡) 111 (103 completed§)
Jewett Stages Stage A - 2 2 5
Stage B - 19 38 43
Stage C 89 60 16 19
Stage D 31 36 34 44
Treatment 6 monthly injections 1 injection (4 patients) 1 injection (5 patients) 1 injection (5 patients)
2 injections, one every three months (113 patients) 2 injections, one every four months (85 patients) 2 injections, one every six months (106 patients)
Duration of therapy 6 months 6 months 8 months 12 months
Mean testosterone concentration (ng/dL) Baseline 361.3 367.1 385.5 367.7
Day 2 574.6 (Day 3) 588.0 610.0 588.6
Day 14 Below Baseline (Day 10) Below Baseline Below Baseline Below Baseline
Day 28 21.8 27.7 (Day 21) 17.2 16.7
Conclusion 6.1 10.1 12.4 12.6
Number of patients below castrate threshold
(≤ 50 ng/dL) Day 28 112 of 119 (94.1%) 115 of 116 (99%) 85 of 89 (96%) 108 of 109 (99.1%)
Day 35 - 116 (100%) - -
Day 42 119 (100%) - 89 (100%) -
Conclusion 117(100%) 111 (100%) 81 (99%) *
Following injection of ELIGARD® 30 mg, three of the 35 burning/stinging events were reported as moderate.
A single event reported as moderate pain resolved within two minutes and all 3 mild pain events resolved within several days following injection of ELIGARD® 30 mg.
Transient pain was reported as mild in intensity in nine of ten (90%) events and moderate in intensity in one of ten (10%) events following injection of ELIGARD® 45 mg.
Erythema was reported following 2 injections of ELIGARD® 22.5 mg. One report characterized the erythema as mild and it resolved within 7 days. The other report characterized the erythema as moderate and it resolved within 15 days. Neither patient experienced erythema at multiple injections.
Mild bruising was reported following 5 (2.3%) study injections and moderate bruising was reported following 2 (<1%) study injections of ELIGARD® 45 mg.
Study Number AGL9904 AGL9909 AGL0001 AGL0205
Number of patients 120 117 90 111
Treatment 1 injection every month up to 6 months 1 injection every 3 months up to 6 months 1 injection every 4 months up to 8 months 1 injection every 6 months up to 12 months
Number of injections 716 230 175 217
Transient burning/stinging 248 (34.6%) injections;84% reported as mild 50 (21.7%) injections; 86% reported as mild 35 (20%) injections; 100% reported as mild 35 (16%) injections; 91.4% reported as mild*
Pain (generally brief and mild) 4.3% of injections (18.3% of patients) 3.5% of injections (6.0% of patients) 2.3% of injections† (3.3% of patients) 4.6% of injections‡
Erythema (generally brief and mild) 2.6% of injections (12.5% of patients) 0.9% of injections§ (1.7% of patients) 1.1% of injections (2.2% of patients)
Bruising (Mild) 2.5% of injections (11.7% of patients) 1.7% of injections (3.4% of patients) 2.3% of injections¶
Pruritis 1.4% of injections (9.2% of patients) 0.4% of injections (0.9% of patients)
Induration 0.4% of injections (2.5% of patients)
Ulceration 0.1% of injections (> 0.8% of patients)
These localized adverse events were non-recurrent over time. No patient discontinued therapy due to an injection site adverse event.
The following possibly or probably related systemic adverse events occurred during clinical trials with ELIGARD®, and were reported in > 2% of patients (Table 7). Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions consid |
