Table 4.
Concordance rate | ||||
---|---|---|---|---|
Patienta | Lymph nodeb | |||
Total N | Concordant N (%) | Total SLN | Concordant SLN (%) | |
Pooled analysis | 131c | 129 (98.47) | 209 | 207 (99.04) |
95 % CId | (94.59–99.81) | (96.59–99.88) | ||
p valuee | 0.0002 | <0.0001 |
N number of ITT patients, SLN number of lymph nodes
aPatient concordance rate: the number of patients for whom all nodes detected by vital blue dye were also detected by [99mTc]tilmanocept divided by the number of patients with at least 1 blue-stained lymph node
bLymph node concordance rate: the number of blue-stained nodes that were detected by [99mTc]tilmanocept divided by the number of blue-stained lymph nodes
cThe intent-to-treat population
d95 % exact binomial confidence interval for pooled analysis proportion
e2-sided p value for exact 1-sample binomial test of pooled analysis concordance against null hypothesis of ≤90 %