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Table H-7. Analysis at the Start R90, R91, and PPPC Bases on all Deaths Regardless of Time Since Enrollment

 

Enrolled

Deaths

Start

No.

No. PYs

Obs

Exp

Diff

p-value

Follow up to start of indicated trial

Low (R89 0.10; R90 0.04; R91 0.02)

R90

12

6.6

3

0.6

2.400

0.05

R91

51

49.0

4

3.1

0.900

0.75

PPPC

79

113.1

9

5.7

3.300

0.25

Intermediate (R89 0.15; R90 0.08; R91 0.03)

R90

12

6.6

3

1.0

2.000

0.16

R91

51

49.0

4

5.3

-1.300

0.45

PPPC

79

113.1

9

10.0

-1.000

0.66

High (R89 0.20; R90 0.12; R91 0.04)

R90

12

6.6

3

1.3

1.700

0.28

R91

51

49.0

4

7.4

-3.400

0.13

PPPC

79

113.1

9

14.2

-5.200

0.11

Assumptions and notes: Enrollment period from 1st dose to last dose; uniform rate of enrollment over that period; instantaneous treatment effect (ie, no treatment lag); instantaneous reports of deaths; 100% followup for mortality over defined followup period; new analysis just prior to start of a new trial. PY = person-years.



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