Table 4.
The temporal patterns appeared in HCV clinical trial eligibility criteria.
| Temporal Pattern | Example | Study Coverage # of Studies (%), N = 77 |
|---|---|---|
| Event X within t time unitsa before/after event Y | e.g., “Clinically significant gastrointestinal bleeding occurring <= 4 weeks prior to randomization” | 42 (54.55%) |
| Cumulative duration t time units of an event X | e.g., “Chronic HCV infection (>= 6 months)” | 25 (32.47%) |
| Event X occurred at least t time units before/after event Y | e.g., “Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening” | 24 (31.69%) |
| Event X before/after Event Y (regardless of how long) | e.g., “A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection” | 3 (3.90%) |
a
The time unit can be day, week, month, or year.