Table 3.
Primary and secondary end point analyses
| Primary/secondary end point | Intention to treat analysisa |
Per protocol analysisb |
Subset analysisc |
||||||
|---|---|---|---|---|---|---|---|---|---|
| VAB (n = 65) | CORE (n = 63) | p-value | VAB (n = 63) | CORE (n = 64) | p-value | VAB (n = 61) | CORE (n = 62) | p-value | |
| Accurate diagnosisd | 54 (83) | 55 (87) | 0.62 | 54 (86) | 54 (84) | 1.00 | 54 (88) | 54 (87) | 1.0 |
| Number of needle biopsy procedures | |||||||||
| 1 | 57 (88) | 58 (92) | 0.56 | 57 (89) | 57 (89) | 1.00 | 57 (93) | 57 (92) | 1.0 |
| 2 | 8 (12) | 5 (8) | 6 (11) | 7 (11) | 4 (7) | 5 (8) | |||
| Number of surgical procedures | |||||||||
| 1 | 9 (56) | 17 (71) | 9 (56) | 17 (71) | 0.50 | 9 (56) | 17 (71) | ||
| 2 | 7 (44) | 7 (29) | 0.50 | 7 (44) | 7 (29) | 7 (44) | 7 (29) | 0.32 | |
CORE, 14-G core biopsy; VAB, 11-G vacuum-assisted biopsy.
Values within parentheses are percentages; Fisher's exact test was used for all comparisons.
a
Intention to treat analysis (Figure 1) 128 participants.
b
Per protocol analysis, 127 participants. Two participants did not receive allocated VAB but underwent core biopsy. One participant underwent both biopsy types and was excluded.
c
Subset analysis excluded participants where technical issues with biopsy or stereotactic equipment may have impacted on results.
d
Accurate diagnosis—diagnosis obtained at first needle biopsy corresponds to final surgical pathology or benign concordant result determined at multidisciplinary review.