Table 1

Application of upper gastrointestinal tract complications (UGIC) risk estimations to the populations of patients included in the control groups (exposed to traditional non-steroidal anti-inflammatory drugs) for the Vioxx Gastrointestinal Outcomes Research (VIGOR), Celecoxib Long-term Arthritis Safety Study (CLASS), and Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) trials

Study

Age mean

Female %

Ulcer History %

Aspirin %

Reported Incidence Per 1,000 p-y

Estimated Incidence Per 1,000 p-y


VIGOR [21]

58

80

7.8

0

8.6*

7.0

CLASS [22]

60

69

9.6

20

14.5

9.5

TARGET [23]

63

76

3.5

24

9.1

8.1


*Excluding 11 cases with gastrointestinal ulcer without apparent bleeding, obstruction, or perforation.

Hernández-Díaz and García Rodríguez BMC Medicine 2006 4:22   doi:10.1186/1741-7015-4-22

Open Data