Toxicity in Patients Treated With RFT5-SMPT-dgA
| Patient No. . | Dose (mg/m2) . | Grade of Toxicity (WHO) . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | Nausea/Vomiting . | Weakness . | Decrease in Albumin1 . | Weight Gain2 . | Hypotension3 . | Tachycardia . | Dyspnea . | Myalgia . | Joint Discomfort . | Thrombopenia . | Allergic Reaction . |
| 1 | 5 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 5 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| 3 | 5 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 4 | 10 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| 5 | 10 | 0 | 1 | 2 | 2 | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
| 6 | 10 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| 7 | 15 | 2 | 3 | 2 | 2 | 1 | 2 | 3 | 3 | 1 | 0 | 0 |
| 8 | 15 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| 9 | 15 | 1 | 2 | 2 | 2 | 2 | 1 | 2 | 1 | 0 | 0 | 2 |
| 10 | 15 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 11 | 15 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 0 |
| 12 | 15 | 1 | 2 | 1 | 1 | 2 | 2 | 3 | 2 | 0 | 0 | 2 |
| 13 | 20 | 0 | 2 | 1 | 3 | 2 | 3 | 2 | 1 | 0 | 0 | 0 |
| 14 | 20 | 3 | 3 | 2 | 2 | 1 | 3 | 3 | 2 | 1 | 0 | 0 |
| 15 | 20 | 3 | 3 | 2 | 2 | 2 | 2 | 3 | 4 | 2 | 0 | 0 |
| Patient No. . | Dose (mg/m2) . | Grade of Toxicity (WHO) . | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | Nausea/Vomiting . | Weakness . | Decrease in Albumin1 . | Weight Gain2 . | Hypotension3 . | Tachycardia . | Dyspnea . | Myalgia . | Joint Discomfort . | Thrombopenia . | Allergic Reaction . |
| 1 | 5 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 5 | 1 | 1 | 0 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| 3 | 5 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 4 | 10 | 0 | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| 5 | 10 | 0 | 1 | 2 | 2 | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
| 6 | 10 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| 7 | 15 | 2 | 3 | 2 | 2 | 1 | 2 | 3 | 3 | 1 | 0 | 0 |
| 8 | 15 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| 9 | 15 | 1 | 2 | 2 | 2 | 2 | 1 | 2 | 1 | 0 | 0 | 2 |
| 10 | 15 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 11 | 15 | 2 | 2 | 2 | 2 | 1 | 1 | 2 | 2 | 1 | 2 | 0 |
| 12 | 15 | 1 | 2 | 1 | 1 | 2 | 2 | 3 | 2 | 0 | 0 | 2 |
| 13 | 20 | 0 | 2 | 1 | 3 | 2 | 3 | 2 | 1 | 0 | 0 | 0 |
| 14 | 20 | 3 | 3 | 2 | 2 | 1 | 3 | 3 | 2 | 1 | 0 | 0 |
| 15 | 20 | 3 | 3 | 2 | 2 | 2 | 2 | 3 | 4 | 2 | 0 | 0 |
Toxicity was evaluated in the first cycle.
Abbreviations: 1, percent maximum decrease in albumin (nadir) compared with the baseline pretreatment values (mean change: dose level 1, 25.7%; level 2, 31.2%; level 3, 25.4%; and level 4, 22.3%); 2, percent maximum increase over the starting body weight (mean change: dose level 1, 4.3%; level 2, 4.6%; level 3, 4.6%; and level 4, 7.7%); 3, Hypotension (systolic blood pressure <100 mmHg, percent maximum decrease in systolic blood pressure compared with baseline values; mean change: dose level 1, 22%; level 2, 19%; level 3, 20%; and level 4, 32%).