Table 2.
Selected Grade 3 or 4 Adverse Events, According to Treatment Arm
| Adverse Event | Maximum Toxicity Grade (% of patients) |
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|---|---|---|---|---|---|---|---|---|
| Arm A: Gemcitabine/Cisplatin (n = 62) |
Arm B: FDR Gemcitabine (n = 58) |
Arm C: Gemcitabine/Docetaxel (n = 65) |
Arm D: Gemcitabine/Irinotecan (n = 60) |
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| Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| Hematologic toxicity | ||||||||
| Neutrophils | 27 | 19 | 26 | 22 | 18 | 14 | 18 | 7 |
| Leukocytes | 32 | 6 | 21 | 16 | 18 | 9 | 13 | 7 |
| Platelets | 47 | 2 | 22 | 3 | 9 | 0 | 12 | 2 |
| Hemoglobin | 13 | 3 | 12 | 0 | 14 | 2 | 5 | 0 |
| Nonhematologic toxicity | ||||||||
| Fatigue | 11 | 5 | 12 | 2 | 18 | 3 | 17 | 2 |
| Hyperglycemia | 6 | 3 | 7 | 2 | 32 | 2 | 8 | 2 |
| Nausea | 23 | 0 | 12 | 0 | 9 | 0 | 15 | 0 |
| Vomiting | 18 | 0 | 12 | 2 | 8 | 0 | 10 | 0 |
| Dehydration | 5 | 0 | 5 | 0 | 8 | 0 | 10 | 0 |
| Diarrhea | 0 | 0 | 2 | 0 | 6 | 2 | 18 | 0 |
| Infection | 6 | 0 | 4 | 2 | 13 | 0 | 3 | 0 |
| Alkaline phosphatase | 6 | 0 | 3 | 0 | 8 | 0 | 8 | 0 |
| Anorexia | 3 | 2 | 5 | 0 | 8 | 0 | 0 | 0 |
| Dyspnea | 0 | 0 | 2 | 0 | 9 | 0 | 3 | 2 |
| Thrombosis | 0 | 3 | 0 | 0 | 5 | 5 | 3 | 0 |
| Bilirubin | 2 | 0 | 2 | 2 | 2 | 0 | 3 | 0 |
| Febrile neutropenia | 2 | 0 | 3 | 0 | 5 | 0 | 2 | 0 |
| Edema | 3 | 0 | 2 | 0 | 2 | 0 | 3 | 2 |
| GI bleeding | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 |
NOTE. Grade 3 or 4 adverse events experienced by two or more patients in any arm are listed. Grade 5 (fatal) toxicities included: arm A, renal failure (n = 2); arm B, infection (n = 1) and seizure (n = 1); and arm D, infection (n = 1).
Abbreviation: FDR, fixed dose rate.