Table 3.
Toxic Reaction Incidence and Grade by Dose Level
| Dose | Adverse Event | N (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|---|
| Level 1*,†(40B‡total) | Nausea and vomiting | 3 (100) | 4 | 3 | ||
| Diarrhea | 1 (33.3) | 2 | ||||
| Malaise | 1 (33.3) | 1 | 1 | |||
| Atrial rhythm | 1 (33.3) | 2 | ||||
| Fever | 3 (100) | 3 | 7 | |||
| Headache | 1 (33.3) | 2 | ||||
| Chills | 2 (66.6) | 7 | ||||
| Hypotension | 2 (66.6) | 4 | ||||
| Hypertension | 1 (33.3) | 1 | ||||
| Sinus tachycardia | 1 (33.3) | 1 | ||||
| Level 2* (60B‡ total) | Chills | 4 (100) | 1§ | |||
| Rhythm, ventricular | 2 (50) | 4§ | 1§ | 9§ | ||
| Hypotension | 1 (25) | 1§ | ||||
| Fever | 3 (100); 4 (100) | 1 | 8§ | 3 | ||
| Headache | 0 (0); 1 (33.3) | 2§ | ||||
| Malaise | 2 (66.6); 2 (66.6) | 7 | ||||
| Nausea | 1 (33.3); 1 (33.3) | 3 | ||||
| Level 3*,†(80B‡ total) | Chills | 2 (66.6) | 5 | 3 | ||
| Malaise | 2 (66.6) | 8 | 4 | |||
| Rhythm, ventricular | 3 (100) | 4 | ||||
| Hypotension | 3 (100) | 3 | 2 | |||
| Fever | 3 (100) | 4 | 8 | |||
| Pulmonary | 1 (33.3) | 1 | 1 | |||
| Headache | 2 (66.6) | 6 | ||||
| Pain | 3 (100) | 4 |
N is the number of patients experiencing adverse event (% of total at the dose level).
*
Dose level on the new version of the protocol that was approved March 3, 2008.
†
Total number of episodes by grade at the dose level.
‡
B indicates dose in billions.
§
These are inclusive of 1 patient, who received only 3 of 4 infusions.