Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of participants with recurrent C. Diff infection at 90 days |
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
90 days |
|
Primary |
Number of participants with recurrent C. Diff infection at 12 months |
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
12 months |
|
Primary |
Number of participants with recurrent C. Diff infection at 24 months |
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
24 months |
|
Secondary |
Change from baseline in inflammatory markers after Bezlotoxumab at 90 days |
Rates of abnormal C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), and albumin defined by "out of normal range" by lab report. |
Baseline, 90 days |
|
Secondary |
Change from 90 days in inflammatory markers after Bezlotoxumab at 12 months |
Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report. |
90 days, 12 months |
|
Secondary |
Change from 12 months in inflammatory markers after Bezlotoxumab at 24 months |
Rates of abnormal CRP,ESR, and albumin defined by "out of normal range" by lab report. |
12 months, 24 months |
|
Secondary |
Change from baseline in disease activity scores after Bezlotoxumab at 90 days |
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. |
Baseline, 90 days |
|
Secondary |
Change from baseline in disease activity scores after Bezlotoxumab at 90 days |
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. |
Baseline, 90 days |
|
Secondary |
Change from 90 days in disease activity scores after Bezlotoxumab at 12 months |
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. |
90 days, 12 months |
|
Secondary |
Change from 90 days in disease activity scores after Bezlotoxumab at 12 months |
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. |
90 days, 12 months |
|
Secondary |
Change from 12 months in disease activity scores after Bezlotoxumab at 24 months |
Disease activity scores Harvey Bradshaw index (HBI). Minimum score 0, No maximum. Active disease defined by HBI >4. |
12 months, 24 months |
|
Secondary |
Change from 12 months in disease activity scores after Bezlotoxumab at 24 months |
Disease activity scores Ulcerative colitis activity index (UCAI). Minimum score 0, No maximum. Active disease defined by UCAI >3. |
12 months, 24 months |
|
Secondary |
Change from baseline in disease related quality of life after Bezlotoxumab at 90 days |
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. |
Baseline, 90 days |
|
Secondary |
Change from 90 days in disease related quality of life after Bezlotoxumab at 12 months |
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. |
90 days, 12 months |
|
Secondary |
Change from 12 months in disease related quality of life after Bezlotoxumab at 24 months |
Short Inflammatory bowel disease questionnaire (SIBDQ) scores from 10 to 70, higher scores designates better quality of life. |
12 months, 24 months |
|
Secondary |
Change from 90 days in healthcare utilization after Bezlotoxumab at 12 months |
Number of emergency department (ED) visits and hospital admissions per participant |
90 days, 12 months |
|
Secondary |
Change from 12 months in healthcare utilization after Bezlotoxumab at 24 months |
Number of emergency department (ED) visits and hospital admissions per participant |
12 months, 24 months |
|
Secondary |
Change from 90 days in healthcare associated charges after Bezlotoxumab at 12 months |
Total charges associated with healthcare utilization per participant |
90 days, 12 months |
|
Secondary |
Change from 12 months in healthcare associated charges after Bezlotoxumab at 24 months |
Total charges associated with healthcare utilization per participant |
12 months, 24 months |
|