um than in patients with hypercalcemia of malignancy treated with the same dose.
Adverse experiences considered to be related to trial drug, which occurred in at least 5% of patients with Paget’s disease treated with 90 mg of pamidronate disodium in two U.S. clinical trials, were fever, nausea, back pain, and bone pain.
At least 10% of all pamidronate disodium-treated patients with Paget’s disease also experienced the following adverse experiences during clinical trials:
Cardiovascular: Hypertension
Musculoskeletal: Arthrosis, bone pain
Nervous system: Headache
Most of these adverse experiences may have been related to the underlying disease state.
Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma
The most commonly reported (>15%) adverse experiences occurred with similar frequencies in the pamidronate disodium and placebo treatment groups, and most of these adverse experiences may have been related to the underlying disease state or cancer therapy.
Commonly Reported Adverse Experiences in Three U.S. Controlled Clinical Trials Pamidronate Disodium 90 mg
over 4 hours
Placebo
Pamidronate Disodium 90 mg
over 2 hours
Placebo
All Pamidronate Disodium
90 mg
Placebo
N=205
%
N=187
%
N=367
%
N=386
%
N=572
%
N=573
%
General
Asthenia
16.1
17.1
25.6
19.2
22.2
18.5
Fatigue
31.7
28.3
40.3
28.8
37.2
29.0
Fever
38.5
38.0
38.1
32.1
38.5
34.0
Metastases
1.0
3.0
31.3
24.4
20.5
17.5
Pain
13.2
11.8
15.0
18.1
14.3
16.1
Digestive System
Anorexia
17.1
17.1
31.1
24.9
26.0
22.3
Constipation
28.3
31.7
36.0
38.6
33.2
35.1
Diarrhea
26.8
26.8
29.4
30.6
28.5
29.7
Dyspepsia
17.6
13.4
18.3
15.0
22.6
17.5
Nausea
35.6
37.4
63.5
59.1
53.5
51.8
Pain Abdominal
19.5
16.0
24.3
18.1
22.6
17.5
Vomiting
16.6
19.8
46.3
39.1
35.7
32.8
Hemic and Lymphatic
Anemia
47.8
41.7
39.5
36.8
42.5
38.4
Granulocytopenia
20.5
15.5
19.3
20.5
19.8
18.8
Thrombocytopenia
16.6
17.1
12.5
14.0
14.0
15.0
Musculoskeletal System
Arthralgias
10.7
7.0
15.3
12.7
13.6
10.8
Myalgia
2
