Table 4.
Summary of Trigger and Progression by Surveillance Group
| All patients |
TM group |
BIS group |
p | |
|---|---|---|---|---|
|
N = 918a |
N = 457 |
N = 461 |
||
| n (%) | n (%) | n (%) | ||
| Progressed before intervention | 39 (4.2) | 20 (4.4) | 19 (4.1) | 0.848 |
| Sample for potential trigger | N = 879 | N = 437 | N = 442 |
| Median (IQR) | Median (IQR) | Median (IQR) | ||
|---|---|---|---|---|
| Follow-up (months)b | 32.9 (22.7, 34.3) | 32.7 (20.8, 34.3) | 33.1 (25.8,34.7) | 0.054 |
| n (%) | n (%) | n (%) | ||
|---|---|---|---|---|
| Triggered | 209 (23.8) | 120 (27.5) | 89 (20.1) | 0.011 |
| Median (IQR) | Median (IQR) | Median (IQR) | ||
|---|---|---|---|---|
| Time from randomization to trigger (months) | 5.1 (1.3, 15.6) | 3.9 (1.0, 11.6) | 9.7 (3.6, 18.2) | 0.001 |
| N = 209 | N = 120 | N = 89 |
| Median (Min, Max) | Median (Min, Max) | Median (Min, Max) | ||
|---|---|---|---|---|
| Time from trigger to progression (months) | 9.6 (0.7, 31.9) | 10.7 (1.4, 31.9) | 4.9 (0.7, 15.2) | 0.100 |
a
Sample with any data post-treatment.
b
Months from randomization to last assessment using either tape or BIS.
c
Progression to criteria for being off-study without the interim intervention (subclinical) threshold.
d
Reduction 11.3%; 95% CI, 2.3–20.3; OR = 0.36; 95% CI, 0.11–0.77, p = 0.016, RR = 0.41; 95% CI, 0.13–0.81.
CI, confidence interval; RR, relative risk.