Reassessment of rifamycin-SV efficacy in two Phase 3 studies based on TD severity categories: median TLUS [h] by baseline disease severity
| TD Category of severity of illness . | Study 1: rifamycin-SV vs placebo (NCT01142089: C2009-0201) . | Study 2: rifamycin-SV vs ciprofloxacin (NCT1209922: RIT-1/AID) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Rifamycin-SV . | Comparison HR . | Ciprofloxacin . | Rifamycin-SV . | Comparison HR . | ||||
| . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . |
| Mild | 3 | 56.4 (7.4, NC) | 6 | 6.9 (0.0, 46.1) | 11.8 (0.5, 261.8) 0.1186 | 3 | 28.0 (27.0, 33.0) | 2 | 42.4 (36.8, 48.0) | NC |
| Moderate | 57 | 68.0 (46.7, NC) | 178 | 47.2 (44.6, 56.0) | 1.7 (1.1, 2.5) 0.0078 | 336 | 33.7 (29.9, 40.2) | 341 | 40.3 (32.5, 45.0) | 0.9 (0.8, 1.1) 0.1856 |
| Severe | 5 | 68.0 (48.7, NC) | 15 | 38.7 (3.2, 46.0) | 5.9 (1.3, 27.5) 0.0232 | 76 | 73.3 (54.3, NC) | 77 | 67.8 (53.5, 97.0) | 1.2 (0.8, 1.9) 0.3245 |
| All subjects | 65 | 68.0 [48.7, NC] | 199 | 46.0 (42.8, 50.5) | 1.9 (1.3, 2.7) 0.0006 | 415 | 40.3 (33.5, 44.8) | 420 | 44.3 (40.1, 47.5) | 0.962 (0.8, 1.1) 0.6084 |
| TD Category of severity of illness . | Study 1: rifamycin-SV vs placebo (NCT01142089: C2009-0201) . | Study 2: rifamycin-SV vs ciprofloxacin (NCT1209922: RIT-1/AID) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Rifamycin-SV . | Comparison HR . | Ciprofloxacin . | Rifamycin-SV . | Comparison HR . | ||||
| . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . |
| Mild | 3 | 56.4 (7.4, NC) | 6 | 6.9 (0.0, 46.1) | 11.8 (0.5, 261.8) 0.1186 | 3 | 28.0 (27.0, 33.0) | 2 | 42.4 (36.8, 48.0) | NC |
| Moderate | 57 | 68.0 (46.7, NC) | 178 | 47.2 (44.6, 56.0) | 1.7 (1.1, 2.5) 0.0078 | 336 | 33.7 (29.9, 40.2) | 341 | 40.3 (32.5, 45.0) | 0.9 (0.8, 1.1) 0.1856 |
| Severe | 5 | 68.0 (48.7, NC) | 15 | 38.7 (3.2, 46.0) | 5.9 (1.3, 27.5) 0.0232 | 76 | 73.3 (54.3, NC) | 77 | 67.8 (53.5, 97.0) | 1.2 (0.8, 1.9) 0.3245 |
| All subjects | 65 | 68.0 [48.7, NC] | 199 | 46.0 (42.8, 50.5) | 1.9 (1.3, 2.7) 0.0006 | 415 | 40.3 (33.5, 44.8) | 420 | 44.3 (40.1, 47.5) | 0.962 (0.8, 1.1) 0.6084 |
Note: NC, not calculable.
Mild illness = disease severity score < 4, moderate illness = disease severity score of 4–8 and severe illness = disease severity score > 8.
HR reflects Kaplan–Meir estimate of time to TLUS event.
Reassessment of rifamycin-SV efficacy in two Phase 3 studies based on TD severity categories: median TLUS [h] by baseline disease severity
| TD Category of severity of illness . | Study 1: rifamycin-SV vs placebo (NCT01142089: C2009-0201) . | Study 2: rifamycin-SV vs ciprofloxacin (NCT1209922: RIT-1/AID) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Rifamycin-SV . | Comparison HR . | Ciprofloxacin . | Rifamycin-SV . | Comparison HR . | ||||
| . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . |
| Mild | 3 | 56.4 (7.4, NC) | 6 | 6.9 (0.0, 46.1) | 11.8 (0.5, 261.8) 0.1186 | 3 | 28.0 (27.0, 33.0) | 2 | 42.4 (36.8, 48.0) | NC |
| Moderate | 57 | 68.0 (46.7, NC) | 178 | 47.2 (44.6, 56.0) | 1.7 (1.1, 2.5) 0.0078 | 336 | 33.7 (29.9, 40.2) | 341 | 40.3 (32.5, 45.0) | 0.9 (0.8, 1.1) 0.1856 |
| Severe | 5 | 68.0 (48.7, NC) | 15 | 38.7 (3.2, 46.0) | 5.9 (1.3, 27.5) 0.0232 | 76 | 73.3 (54.3, NC) | 77 | 67.8 (53.5, 97.0) | 1.2 (0.8, 1.9) 0.3245 |
| All subjects | 65 | 68.0 [48.7, NC] | 199 | 46.0 (42.8, 50.5) | 1.9 (1.3, 2.7) 0.0006 | 415 | 40.3 (33.5, 44.8) | 420 | 44.3 (40.1, 47.5) | 0.962 (0.8, 1.1) 0.6084 |
| TD Category of severity of illness . | Study 1: rifamycin-SV vs placebo (NCT01142089: C2009-0201) . | Study 2: rifamycin-SV vs ciprofloxacin (NCT1209922: RIT-1/AID) . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| . | Placebo . | Rifamycin-SV . | Comparison HR . | Ciprofloxacin . | Rifamycin-SV . | Comparison HR . | ||||
| . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . | n . | Median (95% CI) . | n . | Median (95% CI) . | HR (95% CI) P-value . |
| Mild | 3 | 56.4 (7.4, NC) | 6 | 6.9 (0.0, 46.1) | 11.8 (0.5, 261.8) 0.1186 | 3 | 28.0 (27.0, 33.0) | 2 | 42.4 (36.8, 48.0) | NC |
| Moderate | 57 | 68.0 (46.7, NC) | 178 | 47.2 (44.6, 56.0) | 1.7 (1.1, 2.5) 0.0078 | 336 | 33.7 (29.9, 40.2) | 341 | 40.3 (32.5, 45.0) | 0.9 (0.8, 1.1) 0.1856 |
| Severe | 5 | 68.0 (48.7, NC) | 15 | 38.7 (3.2, 46.0) | 5.9 (1.3, 27.5) 0.0232 | 76 | 73.3 (54.3, NC) | 77 | 67.8 (53.5, 97.0) | 1.2 (0.8, 1.9) 0.3245 |
| All subjects | 65 | 68.0 [48.7, NC] | 199 | 46.0 (42.8, 50.5) | 1.9 (1.3, 2.7) 0.0006 | 415 | 40.3 (33.5, 44.8) | 420 | 44.3 (40.1, 47.5) | 0.962 (0.8, 1.1) 0.6084 |
Note: NC, not calculable.
Mild illness = disease severity score < 4, moderate illness = disease severity score of 4–8 and severe illness = disease severity score > 8.
HR reflects Kaplan–Meir estimate of time to TLUS event.
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