Table 4

The predicted and actual cure rates for CDI patients in the combined 003 and 004 trial databases (mITT patients who have available values for all analyzed variables), and also categorized by treatment assignment on entry into the studies (fidaxomicin or vancomycin)
All patients (n=967) Vancomycin patients (n=494) Fidaxomicin patients (n=473)
ATLAS score Predicted cure rate* (%) (nc/nT) Actual cure rate (%) (nc/nT) Predicted cure rate* (%) (nc/nT) Actual cure rate (%) (nc/nT) Predicted cure rate* (%) (nc/nT) Actual cure rate (%) (nc/nT)
0 100 (161/161) 96.3 (155/161) 100 (75/75) 93.3 (70/75) 100 (86/86) 98.8 (85/86)
1 94.9 (160/169) 93.5 (158/169) 94.9 (84/89) 93.3 (83/89) 94.9 (76/80) 93.8 (75/80)
2 89.8 (144/160) 93.1 (149/160) 89.8 (72/80) 93.8 (75/80) 89.8 (72/80) 92.5 (74/80)
3 84.8 (146/172) 87.2 (150/172) 84.8 (72/85) 87.1 (74/85) 84.8 (74/87) 87.4 (76/87)
4 79.7 (99/124) 78.2 (97/124) 79.7 (58/73) 76.7 (56/73) 79.7 (41/51) 80.4 (41/51)
5 74.6 (68/91) 81.3 (74/91) 74.6 (32/43) 76.7 (33/43) 74.6 (36/48) 85.4 (41/48)
6 69.5 (40/58) 74.1 (43/58) 69.5 (19/28) 78.6 (22/28) 69.5 (21/30) 70 (21/30)
7 64.4 (10/16) 62.5 (10/16) 64.4 (8/12) 58.3 (7/12) 64.4 (3/4) 75 (3/4)
8 59.4 (7/11) 54.6 (6/11) 59.4 (4/7) 57.1 (4/7) 59.4 (2/4) 50 (2/4)
9 54.3 (3/5) 40 (2/5) 54.3 (1/2) 0 (0/2) 54.3 (2/3) 66.7 (2/3)
10 49.2 (N/A) N/A 49.2 (N/A) N/A 49.2 (N/A) N/A
All scores 86.7 (838/967) 87.3 (844/967) 86.0 (425/494) 85.8 (424/494) 87.3 (413/473) 88.8 (420/473)

CDI patients categorized by the ATLAS scoring system, using the regression formula* derived from the ATLAS system applied to the 003 clinical trial.

* Predicted cure rate = 100–5.08 x (ATLAS score).

nc: number of subjects cured in the category nT : total number of subjects in the category N/A: not applicable.

nc values for the predicted column were rounded to the nearest whole number.

Miller et al.

Miller et al. BMC Infectious Diseases 2013 13:148   doi:10.1186/1471-2334-13-148

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