Changes/Corrections to the FDA Statistical Briefing Document
March 10, 2005
1. Page 5, Table 3: The number of “all” subjects enrolled has been corrected.
Table 3: Participant Disposition
|
|
|
Tdap |
Td |
All |
|||
|
Age
|
Study
Termination Information |
n |
% |
n |
% |
n |
% |
|
11-17 |
Enrolled and Randomized Completed Visit 2 Completed entire study Terminated the Study (early) |
1225 1208 1194 31 |
100.0 98.6 97.5 2.5 |
818 812 802 16 |
100.0 99.3 98.0 2.0 |
2053 2029 2005 48 |
100.0 98.8 97.7 2.3 |
|
18-64 |
Enrolled and Randomized Completed Visit 2 Completed entire study Terminated the Study (early) |
1807 1780 1720 87 |
100.0 98.5 95.2 4.8 |
600 594 575 25 |
100.0 99.0 95.8 4.2 |
2427 2394 2315 112 |
100.0 98.6 95.4 4.6 |
|
Total 11-64 |
Enrolled and Randomized Completed Visit 2 Completed entire study Terminated the Study (early) |
3032 2988 2914 118 |
100.0 98.5 96.1 3.9 |
1418 1406 1377 41 |
100.0 99.2 97.1 2.9 |
4480 4423 4320 160 |
100.0 98.7 96.4 3.6 |