vents in pediatric patients, the most frequent events reported were headache, increased transaminase levels, decreased blood potassium, decreased blood albumin, increased blood bilirubin, and vomiting.
The most common adverse events in adults, regardless of causality, were fatigue; gastrointestinal (GI) disorders (nausea, diarrhea, vomiting, and constipation); hematologic disorders ( anemia, neutropenia, and thrombocytopenia); respiratory disorders (cough and dyspnea); nervous system disorders (somnolence and dizziness); and pyrexia.
The most common adverse events by System Organ Class, regardless of causality, including severe or life threatening events (NCI Common Toxicity Criteria grade 3 or grade 4) and fatal events (grade 5) are shown in Table 4 for pediatric patients and Table 5 for adult patients.
Table 4. Most Commonly Reported (≥5% Overall) Adverse Events Regardless of Causality in Pediatric Patients Treated with 650 mg/m2 of ARRANON Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days
|
System Organ Class
Preferred Term
|
Percentage of Patients: 650 mg/m2; N = 84
|
|
Toxicity Grade
|
|
Grade 3
%
|
Grade 4+
%
|
All Grades
%
|
|
Blood and Lymphatic System Disorders
|
|
Anemia
|
45
|
10
|
95
|
|
Neutropenia
|
17
|
62
|
94
|
|
Thrombocytopenia
|
27
|
32
|
88
|
|
Leukopenia
|
14
|
7
|
38
|
|
Hepatobiliary Disorders
|
|
Transaminases increased
|
4
|
0
|
12
|
|
Blood albumin decreased
|
5
|
1
|
10
|
|
Blood bilirubin increased
|
7
|
2
|
10
|
|
Metabolic/Laboratory
|
|
|
|
|
Blood potassium decreased
|
4
|
2
|
11
|
|
Blood calcium decreased
|
1
|
1
|
8
|
|
Blood creatinine increased
|
0
|
0
|
6
|
|
Blood glucose decreased
|
4
|
0
|
6
|
|
Blood magnesium decreased
|
2
|
0
|
6
|
|
Nervous System Disorders |
