Eligibility criteria characteristics for published and recruiting trials belonging to trials in group B
| Exclusion criteria . | With publication (n = 95), n* . | Recruiting (n = 39), n . | Total (N = 134), N . |
|---|---|---|---|
| Maximum age, y | |||
| 59-69 | 3 | 3 | 6 |
| 70-89 | 5 | 0 | 5 |
| 90-100 | 1 | 0 | 1 |
| ECOG PS | |||
| 1 | 3 | 2 | 5 |
| 2 | 60 | 25 | 85 |
| 3 | 5 | 3 | 8 |
| Creatinine (<ULN), mg/dL | |||
| 1.0-1.5 | 16 | 13 | 29 |
| 2.0-2.5 | 41 | 17 | 58 |
| >3 | 2 | 0 | 2 |
| ALT or AST (×ULN), U/L | |||
| 1.0-1.5 | 1 | 0 | 1 |
| 2.0-2.5 | 29 | 19 | 48 |
| >3.0 | 25 | 14 | 39 |
| Total bilirubin (×ULN), mg/dL | |||
| 1.0-1.5 | 26 | 16 | 42 |
| 2.0-2.5 | 27 | 15 | 42 |
| >3.0 | 4 | 1 | 5 |
| Heart failure (any grade) | 29 | 18 | 47 |
| History of or active hepatitis | 20 | 21 | 41 |
| Diagnosis of HIV | 30 | 26 | 56 |
| Uncontrolled HTN | 14 | 3 | 17 |
| Autoimmune disease | 4 | 1 | 5 |
| Diabetes mellitus | 1 | 1 | 2 |
| Chronic kidney disease | 1 | 1 | 2 |
| History of pneumonitis | 0 | 3 | 3 |
| Exclusion criteria . | With publication (n = 95), n* . | Recruiting (n = 39), n . | Total (N = 134), N . |
|---|---|---|---|
| Maximum age, y | |||
| 59-69 | 3 | 3 | 6 |
| 70-89 | 5 | 0 | 5 |
| 90-100 | 1 | 0 | 1 |
| ECOG PS | |||
| 1 | 3 | 2 | 5 |
| 2 | 60 | 25 | 85 |
| 3 | 5 | 3 | 8 |
| Creatinine (<ULN), mg/dL | |||
| 1.0-1.5 | 16 | 13 | 29 |
| 2.0-2.5 | 41 | 17 | 58 |
| >3 | 2 | 0 | 2 |
| ALT or AST (×ULN), U/L | |||
| 1.0-1.5 | 1 | 0 | 1 |
| 2.0-2.5 | 29 | 19 | 48 |
| >3.0 | 25 | 14 | 39 |
| Total bilirubin (×ULN), mg/dL | |||
| 1.0-1.5 | 26 | 16 | 42 |
| 2.0-2.5 | 27 | 15 | 42 |
| >3.0 | 4 | 1 | 5 |
| Heart failure (any grade) | 29 | 18 | 47 |
| History of or active hepatitis | 20 | 21 | 41 |
| Diagnosis of HIV | 30 | 26 | 56 |
| Uncontrolled HTN | 14 | 3 | 17 |
| Autoimmune disease | 4 | 1 | 5 |
| Diabetes mellitus | 1 | 1 | 2 |
| Chronic kidney disease | 1 | 1 | 2 |
| History of pneumonitis | 0 | 3 | 3 |
Group B comprises trials that neither included nor excluded t-MDS patients.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG PS, Eastern Cooperative Oncology Group performance score; HTN, hypertension; ULN, upper limit of normal.
Data are specific to published works with a status marked as completed, terminated, ongoing, or unknown as well as recruiting trials.