Table 3. Reasons for screen failures in matched cases.
| Variables | n (%) |
|---|---|
| Clinical cancer progression | 84 (46) |
| Increased ECOG PS | 54 (30) |
| Discovery of brain metastases | 26 (14) |
| Discovery of other distant metastases | 4 (2) |
| Sponsor | 46 (25) |
| Inadequate lab values | 30 (16) |
| Imaging not compatible with tumor evaluation | 6 (3) |
| ECG abnormalities | 5 (3) |
| Sponsor decision or slot not available | 4 (2) |
| Concomitant medications | 1 (<1) |
| No personal involvement on the part of the patient | 24 (13.5) |
| Consent withdrawal | 23 (13) |
| Potential patient non-compliance | 1 (<1) |
| Relevant comorbidities | 20 (11.5) |
| Physical examination abnormalities* | 15 (8) |
| Interval medical issue | 5 (3) |
| Other | 8 (4) |
Abbreviations: ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group Performance Status; P1, phase 1.
* Physical abnormalities include 7 cases of decreased left ventricular ejection fraction, 4 cases of pulmonary function test abnormalities, 2 cases of infection, 1 case of renal failure, 1 case of neuropathy