ered not drug-related are excluded.
Table 7 Summary of Possible or Probably Related Systemic Adverse Events Reported by > 2% of Patients treated with ELIGARD® 7.5 mg 7.5 mg 22.5 mg 30 mg 45 mg
In the patient populations studied with ELIGARD® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe.
In the patient population studied with ELIGARD® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe.
In the patient population studied with ELIGARD® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe.
In the patient population studied with ELIGARD® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; none were severe.
*
Expected pharmacological consequences of testosterone suppression.
Study Number AGL9904 AGL9802 AGL9909 AGL0001 AGL0205
Number of patients 120 8 117 90 111
Treatment 1 injection every month up to 6 months 1 injection (surgically castrated patients) 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
Body System Adverse Event Number (Percent)
Body as a Whole Malaise and Fatigue 21 (17.5 %) 7 (6.0%) 12 (13.3%) 13 (11.7%)
Weakness 4 (3.6%)
Nervous System Dizziness 4 (3.3%) 4 (4.4%)
Vascular Hot flashes/sweats 68 (56.7%)* 2 (25.0%)* 66 (56.4%)* 66 (73.3%)* 64 (57.7%)*
Renal/Urinary Urinary frequency 3 (2.6%) 2 (2.2%)
Nocturia 2 (2.2%)
Gastrointestinal Nausea 4 (3.4%) 2 (2.2%)
Gastroenteritis/colitis 3 (2.5%)
Skin Pruritis 3 (2.6%)
Clamminess 4 (4.4%)*
Night sweats 3 (3.3%)* 3 (2.7%)*
Alopecia 2 (2.2%)
Musculoskeletal Arthralgia 4 (3.4%)
Myalgia 2 (2.2%) 5 (4.5%)
Pain in limb 3 (2.7%)
Reproductive Testicular atrophy 6 (5.0%) 4 (4.4%)* 8 (7.2%)*
Gynecomastia 2 (2.2%)* 4 (3.6%)*
Testicular pain 2 (2.2%)
Psychiatric Decreased libido 3 (3.3%)*
studied with ELIGARD® 7.5 mg, a total of 86 hot flashes/sweats adverse events were reported in 70 patients. Of these, 71 events (83%) were mild; 14 (16%) were moderate; 1 (1%) was severe.
In the patient population studied with ELIGARD® 22.5 mg, a total of 84 hot flashes/sweats adverse events were reported in 66 patients. Of these, 73 events (87%) were mild; 11 (13%) were moderate; none were severe.
In the patient population studied with ELIGARD® 30 mg, a total of 75 hot flash adverse events were reported in 66 patients. Of these, 57 events (76%) were mild; 16 (21%) were moderate; 2 (3%) were severe.
In the patient population studied with ELIGARD® 45 mg, a total of 89 hot flash adverse events were reported in 64 patients. Of these, 62 events (70%) were mild; 27 (30%) were moderate; n |
