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Trial Comparator Exposure Time Normalizer Tool

Calculate trial comparator exposure time normalizer from explicit caller-supplied inputs.

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Description

Return event rates on a shared person-time base.

Clinical research distinguishes supplied protocol metadata, participant/event records, allocation bookkeeping and an analysis target. A local count, permission flag or denominator choice can help reconcile records without establishing valid consent, randomization, regulatory compliance or a reliable treatment-effect estimate.

Return event rates on a shared person-time base.

When to use this tool

Use Trial Comparator Exposure Time Normalizer when checking the stated clinical-research record, allocation, timing, analysis or evidence-basis convention.

How to use the tool and how it works

  1. Enter activeEvents, comparatorEvents, activePersonTime, comparatorPersonTime, referenceBase. Use the units and conventions below.
  2. Run the tool. Correct any format, range, or cross-field input error before interpreting the output.
  3. Read activeRate, comparatorRate, rateDifference, rateRatio. Use the output convention below.

Return event rates on a shared person-time base. Require nonnegative whole activeEvents, comparatorEvents >= 1 and positive person-times/referenceBase; rates = events*base/time, difference subtracts, ratio = activeEvents*comparatorTime/(comparatorEvents*activeTime).1

Input fieldMeaning and unitsAccepted input
activeEventsActive EventsRequired. Safe integer; minimum 0.
comparatorEventsComparator EventsRequired. Safe integer; minimum 1.
activePersonTimeActive Person TimeRequired. Finite number; strictly above 0.
comparatorPersonTimeComparator Person TimeRequired. Finite number; strictly above 0.
referenceBasePositive reporting person-time base in the same time units as both exposure inputs.Required. Finite number; strictly above 0.
Output fieldInterpretationReturned shape
activeRateActive RateRequired. Finite number.
comparatorRateComparator RateRequired. Finite number.
rateDifferenceRate DifferenceRequired. Finite number.
rateRatioRate RatioRequired. Finite number.
json
{
  "input": {
    "activeEvents": 10,
    "comparatorEvents": 20,
    "activePersonTime": 100,
    "comparatorPersonTime": 400,
    "referenceBase": 100
  },
  "output": {
    "activeRate": 10,
    "comparatorRate": 5,
    "rateDifference": 5,
    "rateRatio": 2
  }
}

Limitations and assumptions

  • Person-time units must match; no confounding adjustment, confidence interval, causal treatment effect or clinical recommendation is provided.
  • Inputs must satisfy both the field types and the cross-field conditions above. Invalid input causes an error; a successful false flag or documented placeholder is a different result.
  • Numeric calculations use binary floating point unless exact decimal-integer arithmetic is explicitly stated. No hidden measurement tolerance or decimal rounding is added; nonfinite or out-of-contract results are rejected. Numeric signed-zero results are exported as zero.

Alternative or Complementary methods

Use the complete approved protocol, authenticated source records and qualified clinical/statistical oversight for actual trial design, conduct and interpretation.

References

  1. Calculation and input contract: clinical-trials/trial-comparator-exposure-time-normalizer — tool.io

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