Patients with TRAEs before consolidation and treatment-related IMAEs
| Variable . | Induction (n = 44) . | Intensification (n = 11) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Any TRAE | 31 (70.5) | 8 (18.2)∗ | 8 (72.7) | 3 (27.3)† |
| TRAEs‡ with ≥2 patients in either phase | ||||
| Hypersensitivity | 9 (20.5) | 0 | 1 (9.1) | 0 |
| Nausea | 9 (20.5) | 0 | 5 (45.5) | 0 |
| Diarrhea | 6 (13.6) | 0 | 1 (9.1) | 0 |
| Infusion-related reaction | 5 (11.4) | 1 (2.3) | 2 (18.2) | 0 |
| Abdominal pain | 4 (9.1) | 0 | 0 | 0 |
| Pyrexia | 4 (9.1) | 0 | 1 (9.1) | 0 |
| Rash | 4 (9.1) | 0 | 0 | 0 |
| Maculopapular rash | 3 (6.8) | 0 | 0 | 0 |
| Vomiting | 3 (6.8) | 0 | 6 (54.5) | 1 (9.1) |
| Alopecia | 2 (4.5) | 0 | 0 | 0 |
| Arthralgia | 2 (4.5) | 0 | 0 | 0 |
| Fatigue | 2 (4.5) | 0 | 0 | 0 |
| Increased AST | 2 (4.5) | 0 | 1 (9.1) | 0 |
| Pruritus | 2 (4.5) | 0 | 0 | 0 |
| Upper abdominal pain | 2 (4.5) | 0 | 0 | 0 |
| Headache | 1 (2.3) | 0 | 2 (18.2) | 0 |
| Variable . | Induction (n = 44) . | Intensification (n = 11) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Any TRAE | 31 (70.5) | 8 (18.2)∗ | 8 (72.7) | 3 (27.3)† |
| TRAEs‡ with ≥2 patients in either phase | ||||
| Hypersensitivity | 9 (20.5) | 0 | 1 (9.1) | 0 |
| Nausea | 9 (20.5) | 0 | 5 (45.5) | 0 |
| Diarrhea | 6 (13.6) | 0 | 1 (9.1) | 0 |
| Infusion-related reaction | 5 (11.4) | 1 (2.3) | 2 (18.2) | 0 |
| Abdominal pain | 4 (9.1) | 0 | 0 | 0 |
| Pyrexia | 4 (9.1) | 0 | 1 (9.1) | 0 |
| Rash | 4 (9.1) | 0 | 0 | 0 |
| Maculopapular rash | 3 (6.8) | 0 | 0 | 0 |
| Vomiting | 3 (6.8) | 0 | 6 (54.5) | 1 (9.1) |
| Alopecia | 2 (4.5) | 0 | 0 | 0 |
| Arthralgia | 2 (4.5) | 0 | 0 | 0 |
| Fatigue | 2 (4.5) | 0 | 0 | 0 |
| Increased AST | 2 (4.5) | 0 | 1 (9.1) | 0 |
| Pruritus | 2 (4.5) | 0 | 0 | 0 |
| Upper abdominal pain | 2 (4.5) | 0 | 0 | 0 |
| Headache | 1 (2.3) | 0 | 2 (18.2) | 0 |
| Treatment-related IMAE category . | Overall (n = 44) . | Pediatric (n = 31) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Rash§ | 4 (9) | 0 | 1 (3) | 0 |
| Immune-mediated IRR | 3 (7) | 1 (2) | 2 (6) | 0 |
| Hypersensitivity | 2 (5) | 0 | 2 (6) | 0 |
| Hypothyroidism | 1 (2) | 0 | 1 (3) | 0 |
| Pneumonitis | 1 (2) | 0 | 0 | 0 |
| Treatment-related IMAE category . | Overall (n = 44) . | Pediatric (n = 31) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Rash§ | 4 (9) | 0 | 1 (3) | 0 |
| Immune-mediated IRR | 3 (7) | 1 (2) | 2 (6) | 0 |
| Hypersensitivity | 2 (5) | 0 | 2 (6) | 0 |
| Hypothyroidism | 1 (2) | 0 | 1 (3) | 0 |
| Pneumonitis | 1 (2) | 0 | 0 | 0 |
Data are given as number (percentage).
AST, aspartate aminotransferase; IMAE, immune-mediated adverse event; IRR, infusion-related reaction.
Included anaphylactic reaction, prolonged activated partial thromboplastin time, increased amylase, increased lipase, decreased neutrophil count, neutropenia, hepatotoxicity, and jugular vein thrombosis (n = 1 each).
One patient experienced vomiting and decreased white blood cell count; one experienced increased lipase; and one experienced neutropenia.
As Common Terminology Criteria for Adverse Events preferred terms.
Included rash, maculopapular rash, and pruritic rash.