Arithmetic Calculation Check
Introduction
Adverse events are sometimes presented above a specific threshold, to view the most common ones.
Purpose
Validates that the proportion of participants (%) (appears in brackets) experiencing a particular AE matches the % amount mentioned in the table title.
Applicability
Inclusion conditions
Table title contains:
- Occurring in > x% of subjects/participants
- Occurring in >= x% of subjects/participants
- Occurring in ≥ x% of subjects/participants
- in > x % of subjects/participants
- in >= x% of subjects/participants
- in ≥ x% of subjects/participants
Exclusion
- Tables that do not contain phrases mentioned above
- If x = 0
- Empty tables
- Listing, Figure, ADaM, LoT
Discrepancies
- At least one of the cells in a row has a value less than the cutoff.
Discrepancy Example
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