Table 2.
Infectious, hematologic, and other adverse events possibly, probably or definitely related to research, excluding single occurrences of grade 1 events
| CTCAE v5.0 term | All dose levels, n = 11 |
Dose level 1 (0.5 μg/kg/d), n = 3 |
Dose level 2 (1 μg/kg/d), n = 4 |
Dose level 3 (2 μg/kg/d), n = 4 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade ≤ 2 | Grade 3 | Grade 4 | Grade ≤ 2 | Grade 3 | Grade 4 | Grade ≤ 2 | Grade 3 | Grade 4 | |
| Infections and infestations (CMV) | 4 | 4 | |||||||||||
| Herpes simplex reactivation | 1 | 1 | |||||||||||
| Shingles | 1 | 1 | |||||||||||
| Sinusitis | 1 | 1 | |||||||||||
| Skin infection | 1 | 1 | |||||||||||
| Lymphocyte count decreased | 3 | 2 | 2 | 4 | 1 | 1 | 3 | 4 | 1 | 1 | |||
| White blood cell decreased | 3 | 4 | 4 | 1 | 5 | 3 | 1 | 2 | 1 | ||||
| Neutrophil count decreased | 3 | 3 | 2 | 3 | 1 | 3 | 1 | ||||||
| Thromboembolic event | 2 | 1 | 1 | ||||||||||
| Anemia | 1 | 7 | 1 | 6 | 1 | 2 | |||||||
| Platelet count decreased | 2 | 1 | 1 | 1 | 1 | 2 | |||||||
| Infusion related reaction | 1 | 2 | 1 | 2 | 1 | 1 | |||||||
| Rash maculo-papular | 3 | 1 | 1 | 3 | |||||||||
| Urticaria | 2 | 1 | 1 | 1 | 1 | ||||||||
| Serum amylase increased | 1 | 1 | |||||||||||
| Fever | 9 | 2 | 2 | 8 | 1 | ||||||||
| Chills | 4 | 4 | 1 | ||||||||||
| Hyponatremia | 8 | 8 | |||||||||||
| Fatigue | 3 | 3 | 4 | 2 | |||||||||
| Aspartate aminotransferase increased | 3 | 2 | 3 | 2 | |||||||||
| Sinus bradycardia | 5 | ||||||||||||
| Hypophosphatemia | 1 | 3 | 1 | 2 | 1 | ||||||||
| Alanine aminotransferase increased | 3 | 1 | 3 | 1 | |||||||||
| Hypoalbuminemia | 2 | 1 | 3 | ||||||||||
| Hyperglycemia | 3 | 3 | |||||||||||
| Nausea | 3 | 2 | 1 | ||||||||||
| Bone pain | 1 | 1 | 2 | ||||||||||
| Gastroesophageal reflux disease | 1 | 1 | 2 | ||||||||||
| Anorexia | 2 | 2 | |||||||||||
| Creatinine increased | 2 | 2 | |||||||||||
| Hyperkalemia | 2 | 2 | |||||||||||
| Pruritus | 1 | 1 | |||||||||||