Table. Baseline Trial Cohort Characteristics and Use of Potentially Exclusionary Criteriaa.
| Characteristic | sCr | ANC | sCr and/or ANC | Total No. | |||
|---|---|---|---|---|---|---|---|
| No. (%) | P Value | No. (%) | P Value | No. (%) | P Value | ||
| Sponsor type | |||||||
| Academic/investigator initiated | 55 (34.8) | <.001 | 85 (53.8) | <.001 | 101 (63.9) | <.001 | 158 |
| Cooperative group | 28 (33.3) | 51 (60.7) | 60 (71.4) | 84 | |||
| Industry | 18 (11.3) | 30 (18.9) | 31 (19.5) | 159 | |||
| Phase | |||||||
| 1 | 19 (31.7) | .47 | 25 (41.7) | .001 | 31 (51.7) | .02 | 60 |
| 2 | 48 (23.8) | 102 (50.5) | 109 (54.0) | 202 | |||
| 3 | 33 (25.2) | 38 (29.0) | 50 (38.2) | 131 | |||
| Unknown | 1 (12.5) | 1 (12.5) | 2 (25.0) | 8 | |||
| Year | |||||||
| 1990-2005 | 33 (35.5) | .03 | 41 (44.1) | .72 | 52 (55.9) | .18 | 93 |
| 2006-2011 | 34 (23.6) | 56 (38.9) | 63 (43.8) | 144 | |||
| 2012-2017 | 34 (20.9) | 68 (41.7) | 76 (46.6) | 163 | |||
| Unknown | 0 | 1 (100) | 1 (100) | 1 | |||
| Accrual | |||||||
| Median (IQR) | 60 (27-228) | .02 | 52.5 (28-150) | <.001 | 54.5 (28-164) | <.001 | 85.0 (39-362) |
| Unknown | 1 (100) | 1 (100) | 1 (100) | 1 | |||
| Toxicity | |||||||
| Less toxic | 38 (19.7) | .02 | 59 (30.6) | <.001 | 72 (37.3) | <.001 | 193 |
| More toxic | 63 (30.3) | 107 (51.4) | 120 (57.7) | 208 | |||
| Total | 101 (25.2) | 166 (41.4) | 192 (47.9) | 401 | |||
Abbreviations: ANC, absolute neutrophil count; IQR, interquartile range; sCr, serum creatinine.
a
P values derived from Pearson χ2 test for categorical variables and the Wilcoxon rank sum test for continuous variables.