Table 3.
The number of patients in each trial dataset, broken down by endpoint and baseline variables, including follow-up information, for incontinence and frequency.
| RADAR | RT01 | CHHiP | COMBINED | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Incontinence (grade ≥ 2) | Frequency (grade ≥ 2) | Incontinence (grade ≥ 2) | Frequency (grade ≥ 2) | Incontinence (grade ≥ 2) | Frequency (grade ≥ 2) | Incontinence (grade ≥ 2) | Frequency (grade ≥ 2) | |||||
| Total number of patients | 647 | 416 | Total number of patients | 354 | 264 | Total number of patients | 242 | 206 | Total number of patients | 1243 | 886 | |
| Events | 24 (3.7%) | 125 (30.0%) | Events | 26 (7.3%) | 131 (49.6%) | Events | 6 (2.5%) | 33 (16.0%) | Events | 56 (4.5%) | 289 (32.6%) | |
| Follow-up in months (min, max, med, IQR) | (12, 84, 54, 36) | (12, 84, 18, 36) | Follow-up in months (min, max, med, IQR) | (6, 152, 103, 48) | (12, 158, 60, 90) | Follow-up in months (min, max, med, IQR) | (6, 68, 60, 2) | (6, 67, 60, 3) | Follow-up in months (min, max, med, IQR) | (6, 158, 60, 30) | (6, 158, 48, 46) | |
| Variables | Definitions | Definitions | Definitions | Definitions | ||||||||
| Agea | Median | 69.5 yrs | 69.1 yrs | Median | 67.6 yrs | 68.6 yrs | Median | 67.3 yrs | 67.3 yrs | Median | 68.4 yrs | 68.4 yrs |
| Prescribed dose | [66 Gy] [70 Gy] [74 Gy] |
82 358 207 |
43 230 143 |
[64 Gy] [74 Gy] |
186 168 |
141 123 |
[57 Gy] [60 Gy] [74 Gy] |
84 81 77 |
72 70 64 |
[66 Gy (RADAR), 64 Gy (RT01), 57 Gy and 60 Gy (CHHiP)] [70 Gy and 74 Gy (RADAR), 74 Gy (RT01), 74 Gy (CHHiP)] |
433 810 |
326 560 |
| Disease risk | [GS ≤ 7] [GS > 7] |
457 190 |
288 128 |
[T1b/c or T2a with (PSA + (GS - 6)*10) < 15] [T1b/c or T2a with (PSA + (GS - 6)*10) ≥ 15 or T2b/T3a] |
101 253 |
74 190 |
[T1b/c or T2a with PSA ≤ 10 and GS ≤ 6] [Any of the following: Stage ≥ T2b, 10 < PSA ≤ 20, GS > 6] |
58 184 |
51 155 |
[Lower risk group patients from each respective dataset] [Higher risk group patients from each respective dataset] | 616 627 |
413 473 |
| Cancer stage | [T2] [T3/T4] |
465 182 |
305 111 |
[≤ T2a (T1b, T1c, T2a)] [> T2a (T2b, T3a)] |
216 138 |
156 108 |
[≤ T2a (T1a, T1b, T1c, T2a)] [> T2a (T2b, T2c, T3a)] |
176 66 |
152 53 |
[Lower cancer stage group patients from each respective dataset] [Higher cancer stage group patients from each respective dataset] | 857 386 |
613 273 |
| Baseline PSAa | Median | 14.04 ng/ml | 14.25 ng/ml | Median | 13.40 ng/ml | 14.00 ng/ml | Median | 11.70 ng/ml | 11.85 ng/ml | Median | 13.45 ng/ml | 13.60 ng/ml |
| Number of beams | [3 beams] [4 beams] [5 beams] [6 beams] [≥ 7 beams] |
69 345 85 89 59 |
44 223 58 52 39 |
[3 beams for phase 1 of treament] [4 beams for phase 1 of treament] |
212 142 |
159 105 |
[≤ 4 beams] [> 4 beams] |
212 30 |
181 25 |
[≤ 4 beams (RADAR), 3 beams (RT01), ≤ 4 beams (CHHiP)] [> 4 beams (RADAR), 4 beams (RT01), > 4 beams (CHHiP)] |
838 405 |
607 279 |
a
This variable was divided into two approximately equal subgroups split about the median value.