Table 1.
Reasons for premature study discontinuation of the study (N = 21).
| PET responders (N = 69) |
Group A (N = 48) |
Group B (N = 25) |
Total (N = 142) |
|
|---|---|---|---|---|
| Premature end-of-study | 8 (11.6%) | 10 (20.8%) | 3 (12.0%) | 21 (14.8%) |
| Reasons for discontinuation | ||||
| n | 7 | 10 | 3 | 20 |
| Consent withdrawal | 1 (14.3%) | 5 (50.0%) | 0 | 6 (30.0%) |
| Death | 0 | 2 (20.0%) | 1 (33.3%) | 3 (15.0%) |
| Major protocol deviation | 1 (14.3%) | 1 (10.0%) | 0 | 2 (10.0%) |
| Lost to follow up | 1 (14.3%) | 1 (10.0%) | 0 | 2 (10.0%) |
| Other reason | 4 (57.1%)* | 1 (10.0%)† | 2 (66.7%)‡ | 7 (35.0%) |
| Missing data | 1 | 0 | 0 | 1 |
⁎
Blood glucose not measured at baseline and PET n°2 not performed as per Protocol (n = 1), discovery of a non-inclusion criterion (1.5 months after inclusion; n = 1), bone metastasis diagnosed later (n = 1), and patient diagnosed M1 after the PET scan and withdrawn at Sponsor's request (n = 1);.
†
Patient moved abroad (n = 1);.
‡
Patient included in another clinical trial (n = 2).