Table 2.
TRAEs.
| Grade 1–2 |
Grade 3–5 |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Laboratory abnormalities | Cohort 1 (n = 3) |
Cohort 2 (n = 6) |
Cohort 3 (n = 3) |
Cohort 4 (n = 5) |
Cohort 5 (n = 3) |
Cohort 6 (n = 6) |
Cohort 1 (n = 3) |
Cohort 2 (n = 6) |
Cohort 3 (n = 3) |
Cohort 4 (n = 5) |
Cohort 5 (n = 3) |
Cohort 6 (n = 6) |
Total (%) (n = 26) |
| LDH elevation | 3 | 6 | 3 | 5 | 3 | 6 | — | — | — | — | — | — | 26 (100) |
| AST elevation | 3 | 3 | 2 | 2 | 2 | 2 | — | 2 | 1 | 3 | 1 | 4 | 25 (96) |
| CK elevation | 1 | 3 | 1 | 1 | 2 | 2 | 2 | 2 | 2 | 4 | 1 | 4 | 25 (96) |
| ALT elevation | 1 | 3 | 2 | 2 | 3 | 6 | — | — | 1 | 1 | — | — | 19 (73) |
| Alkaline phosphatase elevation | 1 | 1 | — | — | 1 | 1 | — | — | — | — | — | — | 4 (15) |
| Grade 1–2 |
Grade 3–5 |
||||||||||||
| Clinical events | Cohort 1 (n = 3) |
Cohort 2 (n = 6) |
Cohort 3 (n = 3) |
Cohort 4 (n = 5) |
Cohort 5 (n = 3) |
Cohort 6 (n = 6) |
Cohort 1 (n = 3) |
Cohort 2 (n = 6) |
Cohort 3 (n = 3) |
Cohort 4 (n = 5) |
Cohort 5 (n = 3) |
Cohort 6 (n = 6) |
Total (%) (n = 26) |
| Periorbital edemaa | 2 | 4 | 3 | 2 | 2 | 3 | — | — | — | — | — | — | 16 (62) |
| Fatigue | 2 | 2 | 2 | 1 | 2 | 4 | — | — | — | — | — | — | 13 (50) |
| Cytokine release syndromeb | 2 | 1 | — | 1 | 3 | 4 | — | — | — | — | — | — | 11 (42) |
| Rash – maculopapular | — | 3 | 2 | 2 | — | 2 | — | — | — | — | — | — | 9 (35) |
| Pruritis | 1 | — | 2 | 2 | — | 1 | — | — | — | — | — | — | 6 (23) |
| Infusion-related reactionc | — | 1 | — | — | 1 | 2 | — | — | — | — | — | — | 4 (15) |
| Myalgia | 2 | 2 | — | — | 1 | — | — | — | — | — | — | — | 5 (19) |
| Nausea | 1 | — | 1 | — | 1 | 1 | — | — | — | — | — | — | 4 (15) |
| Headache | 1 | — | 1 | 1 | — | 1 | — | — | — | — | — | — | 4 (15) |
| Diarrhea | — | — | 2 | — | 1 | 1 | — | — | — | — | — | — | 4 (15) |
| Vomiting | 1 | — | — | — | 1 | 1 | — | — | — | — | — | — | 3 (12) |
| Anorexia | — | — | — | 1 | 1 | — | — | — | — | — | — | — | 2 (8) |
| Edema – limbs | — | 1 | — | — | — | 1 | — | — | — | — | — | — | 2 (8) |
| Hoarseness | 1 | — | — | — | — | — | — | — | — | — | — | — | 1 (4) |
| Acute respiratory distress syndrome | — | — | — | — | — | — | — | 1 | — | — | — | — | 1 (4) |
| Pain – back | 1 | — | — | — | — | — | — | — | — | — | — | — | 1 (4) |
| Erythema multiforme | — | — | 1 | — | — | — | — | — | — | — | — | — | 1 (4) |
| Dry mouth | — | — | — | 1 | — | — | — | — | — | — | — | — | 1 (4) |
| Sleep apnea | — | — | — | 1 | — | — | — | — | — | — | — | — | 1 (4) |
| Joint pain | — | — | — | — | 1 | — | — | — | — | — | — | — | 1 (4) |
| Uveitis | — | — | — | — | 1 | — | — | — | — | — | — | — | 1 (4) |
| Peripheral sensory neuropathy | — | — | — | — | — | 1 | — | — | — | — | — | — | 1 (4) |
| Clogged ears | — | — | — | — | 1 | — | — | — | — | — | — | — | 1 (4) |
| Paresthesia | — | — | — | — | — | 1 | — | — | — | — | — | — | 1 (4) |
| Muscle weakness | — | — | — | — | — | 1 | — | — | — | — | — | — | 1 (4) |
Note: Patients reporting more than one AE of the same term were counted once at the highest grade reported. AEs were deemed “treatment-related” if they were possibly, probably, or definitely related to one or more of the study drugs.
a
“Periorbital edema” also includes the term “facial swelling.”
b
“Cytokine release syndrome” includes the terms “fever,” “chills,” “sweats,” and “night sweats” and the symptoms occurred after drug dosing.
c
“Infusion-related reaction” includes the terms “chills” and “flushing” and the symptoms occurred during drug dosing.