Table 3

Primary and secondary clinical end points, by treatment arm

Results show number of subjects experiencing a given end point, by treatment arm. RR and 95% CIs are shown and are adjusted for age and smoking status at baseline.

End pointβ-CarotenePlaceboRR(95% CI)
Local recurrence+ second primary tumor3334a0.900.56–1.45
Local recurrence16210.720.37–1.39
Second primary tumor17141.200.59–2.45
Site of Second Cancer
Head and neck 3 4
Esophagus 1 1
Lung13 91.440.62–3.39
Any second head and neck cancer (local recurrence or new primary)19250.690.39–1.25
Total deaths29330.860.52–1.42
Cause of death
Head/Neck/Esophagus/Lung cancer1514
Cardiovascular disease 611
Other cancer 5 2
Miscellaneous 3 6
Age at death (mean± SD)69.7 ± 6.464.4 ± 8.8P = 0.01
  • a One patient had both a local recurrence and a second primary tumor. This patient was included in the RR calculation for second primary tumors but not for local recurrences.