Table 4.
Tape measurement | BIS | ||
---|---|---|---|
N = 508 | N = 245 | N = 263 | |
Follow-up (months)a | 17.8 (13–23) | 17.6 (13–23) | 18.2 (13–23) |
Progressed before interventionb | 10 (2.0) | 6 (2.4) | 4 (1.5) |
N = 498 | N = 239 | N = 259 | p-Value | |
---|---|---|---|---|
Sample for potential trigger | ||||
Triggeredb | 109 (21.9) | 68 (28.5) | 41 (15.8) | 0.001 |
Median months to triggera | 4.0 (1.0–11.2) | 2.8 (0.6–5.6) | 9.5 (2.3–10.1) | 0.002 |
Progressionb | 12 (11.0) | 10 (14.7) | 2 (4.9) | 0.130 |
Median time, months [trigger to progression]c | 6.0 (0.8, 16.9) | 6.0 (1.4, 16.9) | 6.7 (0.8, 12.5) | 0.389 |
Bold values indicate statistical significance (p < 0.05)
Months from randomization to last assessment for these analyses
Progression to criteria for being off-study without the interim intervention (subclinical) threshold
BIS bioimpedance spectroscopy, IQR interquartile range
aMedian (IQR)
bn (%)
cMedian (minimum, maximum)