Table 3.
Hematologic and non-hematologic toxicity.*
Hematologic | |||||||
---|---|---|---|---|---|---|---|
Median time to nadir (range) |
Median nadir value (range) |
Patients with grade 3 or 4 nadir |
Patients with grade 4 nadir |
||||
Absolute neutrophil count (cells/mm3) |
7 weeks (5–9) | 1,000 (210–2,100) | 29% | 7% | |||
Platelets (cells/mm3) | 5 weeks (3–8) | 51,000 (22,000– 129,000) |
46% | 0% | |||
Hemoglobin (gm/dL) | 7 weeks (4–13) | 11.8 (7.4–13.5) | 18% | 0% | |||
Non-hematologic adverse event | |||||||
System | Grade 1 | Grade 2 | Grade 3 | Grade 4 | No. |
Total^ % |
|
Skin | |||||||
Green discoloration | 11 | 12 | 0 | 0 | 23 | 79 | |
Pruritis | 5 | 0 | 0 | 0 | 5 | 17 | |
Body as whole | |||||||
Fatigue | 18 | 4 | 0 | 0 | 22 | 76 | |
Hypoabluminema | 9 | 6 | 0 | 0 | 15 | 52 | |
Infection | 2 | 7 | 1 | 0 | 9 | 31 | |
Chills/rigors (during rituximab) | 5 | 2 | 0 | 0 | 7 | 24 | |
Insomnia | 6 | 1 | 0 | 0 | 7 | 24 | |
Headache | 3 | 3 | 0 | 0 | 6 | 21 | |
Edema | 1 | 4 | 0 | 0 | 5 | 17 | |
Pain (myalgia) | 2 | 2 | 0 | 0 | 4 | 14 | |
Gastrointestinal | |||||||
Constipation | 11 | 3 | 0 | 0 | 14 | 48 | |
Nausea | 11 | 1 | 0 | 0 | 12 | 41 | |
Diarrhea | 4 | 0 | 0 | 0 | 4 | 14 | |
Vomiting | 4 | 0 | 0 | 0 | 4 | 14 | |
Hepatic | |||||||
Transaminases | 11 | 1 | 0 | 0 | 12 | 41 | |
Alkaline phosphatase | 10 | 0 | 0 | 0 | 10 | 34 | |
GGT elevation | 8 | 1 | 0 | 0 | 9 | 31 | |
Bilirubin | 7 | 0 | 0 | 0 | 7 | 24 | |
Cardiovascular | |||||||
Hypertension | 8 | 0 | 0 | 0 | 8 | 28 | |
Tachycardia | 6 | 0 | 0 | 0 | 6 | 21 | |
Electrolytes | |||||||
Hyponatremia | 7 | 0 | 0 | 0 | 7 | 24 | |
Hypophosphatemia | 3 | 3 | 0 | 0 | 6 | 21 | |
Hypokalemia | 4 | 0 | 1 | 0 | 6 | 21 | |
Hypocalcemia | 5 | 0 | 0 | 0 | 5 | 17 | |
Bicarbonate | 4 | 0 | 0 | 0 | 4 | 14 | |
Hypomagnesemia | 4 | 0 | 0 | 0 | 4 | 14 | |
Renal | |||||||
Creatinine | 4 | 0 | 0 | 0 | 4 | 14 |
The incidence included all grade 3 or 4 adverse events and those grade 1 and 2 that occurred in > 10%10% of patients relationship during the treatment period which were classified as probably or possibly related to study drug or relationship unknown.
Percent of total patients who received MGd/90Y ibritumomab tiuxetan (n=29).