sion. Sixty-seven patients (29%) reported fever, rigors/chills, or sweating within 14 days following the dosimetric dose. Although all patients in the clinical studies received pretreatment with acetaminophen and an antihistamine, the value of premedication in preventing infusion-related toxicity was not eva luated in any of the clinical studies. Infusional toxicities were managed by slowing and/or temporarily interrupting the infusion. Symptomatic management was required in more severe cases. Adjustment of the rate of infusion to control adverse reactions occurred in 16 patients (7%); seven patients required adjustments for only the dosimetric infusion, two required adjustments for only the therapeutic infusion, and seven required adjustments for both the dosimetric and the therapeutic infusions. Adjustments included reduction in the rate of infusion by 50%, temporary interruption of the infusion, and in 2 patients, infusion was permanently discontinued.
Table 5 lists clinical adverse events that occurred in ≥5% of patients. Table 6 provides a detailed description of the hematologic toxicity.
Table 5: Incidence of Clinical Adverse Experiences Regardless of Relationship to Study Drug Occurring in ≥5% of the Patients Treated with BEXXAR Therapeutic Regimen a (N = 230) Body System
Preferred Term
All Grades
Grade 3/4
Total
(96%)
(48%)
Non-Hematologic AEs
Body as a Whole
81%
12%
Asthenia
46%
2%
Fever
37%
2%
Infectionb
21%
<1%
Pain
19%
1%
Chills
18%
1%
Headache
16%
0%
Abdominal pain
15%
3%
Back pain
8%
1%
Chest pain
7%
0%
Neck pain
6%
1%
Cardiovascular System
26%
3%
Hypotension
7%
1%
Vasodilatation
5%
0%
Digestive System
56%
9%
Nausea
36%
3%
Vomiting
15%
1%
Anorexia
14%
0%
Diarrhea
12%
0%
Constipation
6%
1%
Dyspepsia
6%
<1%
Endocrine System
7%
0%
Hypothyroidism
7%
0%
Metabolic and Nutritional Disorders
21%
3%
Peripheral edema
9%
0%
Weight loss
6%
<1%
Musculoskeletal System
23%
3%
Myalgia
13%
<1%
Arthralgia
10%
1%
Nervous System
26%
3%
Dizziness
5%
0%
Somnolence
5%
0%
Respiratory System
44%
8%
Cough increased
21%
1%
Pharyngitis
12%
0%
Dyspnea
11%
3%
Rhinitis
10%
0%
Pneumonia
