Nonmyalgia infusion-related adverse experiences
| . | ABX-CBL dose (mg/kg) . | ||||
|---|---|---|---|---|---|
| 0.01 . | 0.1 . | 0.15 . | 0.2 . | 0.3 . | |
| Cohort size | 9 | 7 | 5 | 35 | 3 |
| No. patients reporting an event | 1 (11%) | 2 (29%) | 1 (20%) | 13 (37%) | 1 (33%) |
| No. events reported | 1 | 2 | 1 | 17 | 1 |
| Body system | |||||
| Cardiac | — | — | — | 1, Increased heart rate (moderate) | 1, Edema (severe) |
| Gastrointestinal | — | — | 1, Abdominal cramp with diarrhea (moderate) | 1, Abdominal pain after infusions (moderate) | — |
| General | 1, Fever with chills (moderate) | 1, Fever (moderate) | — | 1, Chills (mild) 1, Weak legs and fatigue (moderate) 2, Fever with infusion (moderate) 1, Fever (severe) | — |
| Hepatobiliary | — | — | — | 1, Including lactate dehydrogenase (mild) 1, Liver failure (maximum) | — |
| Neurologic | — | — | — | 1, Headache (mild) 1, Nonspecific numbness (mild) | — |
| Respiratory | — | — | — | 2, Tachypnea with infusion (moderate) 1, Chest tightness (moderate) | — |
| Vascular | — | 1, Hypotension (moderate) | — | 1, Transient drop in blood pressure (moderate) 1, Hypotension (moderate) | — |
| Skin and subcutaneous tissue | — | — | — | 1, Severe diaphoresis with infusion (moderate) | — |
| . | ABX-CBL dose (mg/kg) . | ||||
|---|---|---|---|---|---|
| 0.01 . | 0.1 . | 0.15 . | 0.2 . | 0.3 . | |
| Cohort size | 9 | 7 | 5 | 35 | 3 |
| No. patients reporting an event | 1 (11%) | 2 (29%) | 1 (20%) | 13 (37%) | 1 (33%) |
| No. events reported | 1 | 2 | 1 | 17 | 1 |
| Body system | |||||
| Cardiac | — | — | — | 1, Increased heart rate (moderate) | 1, Edema (severe) |
| Gastrointestinal | — | — | 1, Abdominal cramp with diarrhea (moderate) | 1, Abdominal pain after infusions (moderate) | — |
| General | 1, Fever with chills (moderate) | 1, Fever (moderate) | — | 1, Chills (mild) 1, Weak legs and fatigue (moderate) 2, Fever with infusion (moderate) 1, Fever (severe) | — |
| Hepatobiliary | — | — | — | 1, Including lactate dehydrogenase (mild) 1, Liver failure (maximum) | — |
| Neurologic | — | — | — | 1, Headache (mild) 1, Nonspecific numbness (mild) | — |
| Respiratory | — | — | — | 2, Tachypnea with infusion (moderate) 1, Chest tightness (moderate) | — |
| Vascular | — | 1, Hypotension (moderate) | — | 1, Transient drop in blood pressure (moderate) 1, Hypotension (moderate) | — |
| Skin and subcutaneous tissue | — | — | — | 1, Severe diaphoresis with infusion (moderate) | — |
None of these events occurred in more than 3 patients.
Myalgias are summarized in Table 6.