ne1 0/86 — 1/100 (1%)
Hypocalcemia2 0/86 — 0/100 —
Hypophosphatemia3 1/70 (1%) 4/81 (5%)
Hypomagnesemia4 0/71 — 1/84 (1%)
1 Grade 3 (>3x Upper Limit of Normal); Grade 4 (>6x Upper Limit of Normal)
2 Grade 3 (<7 mg/dL); Grade 4 (<6 mg/dL)
3 Grade 3 (<2 mg/dL); Grade 4 (<1 mg/dL)
4 Grade 3 (<0.8 mEq/L); Grade 4 (<0.5 mEq/L)
Table 6: Percentage of Patients with Adverse Events ≥10% Reported in Three Bone Metastases Clinical Trials by Body System Zometa Pamidronate Placebo
4 mg 90 mg
n (%) n (%) n (%)
Patients Studied
Total No. of Patients 1031 (100) 556 (100) 455 (100)
Total No. of Patients with any AE 1015 (98) 548 (99) 445 (98)
Blood and Lymphatic
Anemia 344 (33) 175 (32) 128 (28)
Neutropenia 124 (12) 83 (15) 35 (8)
Thrombocytopenia 102 (10) 53 (10) 20 (4)
Gastrointestinal
Nausea 476 (46) 266 (48) 171 (38)
Vomiting 333 (32) 183 (33) 122 (27)
Constipation 320 (31) 162 (29) 174 (38)
Diarrhea 249 (24) 162 (29) 83 (18)
Abdominal Pain 143 (14) 81 (15) 48 (11)
Dyspepsia 105 (10) 74 (13) 31 (7)
Stomatitis 86 (8) 65 (12) 14 (3)
Sore Throat 82 (8) 61 (11) 17 (4)
General Disorders and Administration Site
Fatigue 398 (39) 240 (43) 130 (29)
Pyrexia 328 (32) 172 (31) 89 (20)
Weakness 252 (24) 108 (19) 114 (25)
Edema Lower Limb 215 (21) 126 (23) Manufacturer
Novartis Pharmaceuticals Corporation (NPC), a US subsidiary of Novartis AG
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011
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