TABLE 3

Investigator assessment of clinical outcome

Assessment by time pointCE population (n = 88)ME population (n = 76)
End of treatment
    No. (%a) response
        Cure79 (89.8)69 (90.8)
        Improved3 (3.4)2 (2.6)
        Failure6 (6.8)5 (6.6)
        Indeterminate0 (0.0)0 (0.0)
        Missing0 (0.0)0 (0.0)
    Clinical success rateb: no./N′c (%d)e82/88 (93.2)71/76 (93.4)
        95% CIf85.7, 97.585.3, 97.8
Short-term follow-up
    No. (%a) response
        Cure82 (93.2)71 (93.4)
        Failure6 (6.8)5 (6.6)
        Indeterminate0 (0.0)0 (0.0)
        Missing0 (0.0)0 (0.0)
    Clinical success rateb: no./N′c (%d)82/88 (93.2)71/76 (93.4)
        95% CIf85.7, 97.585.3, 97.8
Long-term follow-up
    No. (%a) response
        Cure81 (92.0)70 (92.1)
        Failure6 (6.8)5 (6.6)
        Indeterminate0 (0.0)0 (0.0)
        Missing1 (1.1)1 (1.3)
    Clinical success rateb: no./N′c (%d)81/87 (93.1)70/75 (93.3)
        95% CIf85.6, 97.485.1, 97.8
  • a Percentages for cure, improved, failure, and indeterminate responses were based on use of the number in the column heading as the denominator.

  • b Clinical success rate was defined as (no. of cures)/(no. of cures + no. of failures) × 100.

  • c N′, the number of patients with clinical outcome of cure or failure at the specified time point.

  • d Percentages for the clinical success rate were calculated using N′ as the denominator.

  • e For the end-of-treatment clinical success rate calculation, patients who had clinical outcomes of improved were classified as cures.

  • f CI, confidence interval. 95% CIs are exact binomial confidence intervals.