Table 4.
CTM misclassifications
Misclassification category | Misclassifications detail | Number of misclassifications per trial |
||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | All | ||
Stage | Failure to detect metastatic disease status for patient with non-metastatic primary staging but metastatic disease at screening | 0 | 3 | 0 | 1 | 1 | 3 | 0 | 1 | 3 | 2 | 14 |
Failure to detect disease stage as not advanced/metastatic | 0 | 0 | 0 | 2 | 0 | 4 | 3 | 0 | 2 | 6 | 17 | |
Failure to detect absence of measurable disease | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | |
Detection of metastatic disease but failure to recognize as exclusion | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 0 | 13 | |
Diagnosis | Failure to recognize mutation status as exclusion criteria | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
Failure to recognize histology as exclusion criteria | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | |
Treatment | Failure to consider prior therapy as part of exclusion criteria | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 2 | 0 | 5 |
Failure to consider timing of prior therapy as part of exclusion criteria | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | |
Failure to consider location of prior radiotherapy as part of exclusion criteria | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 0 | 0 | 0 | 18 | |
Pathology | Failure to apply correct logic relating to LFT in context of liver metastasis | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 2 |
Other | Exclusion rules for sub-cohorts applied to overall study | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Failure to recognize absence of progressive/recurrent disease | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 |
Abbreviations: CTM: clinical trial matching; LFT: liver function tests.