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