Skip to content

Main content

Trial Randomized Treated Denominator Choice Tool

Keep supplied analysis population denominators explicit.

Loading tool…

Description

Return a success proportion using randomized or treated subjects.

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 a success proportion using randomized or treated subjects.

When to use this tool

Use Trial Randomized Treated Denominator Choice 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 randomized, treated, assessed, successes, useRandomized. 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 denominator, proportion, unassessedTreated. Use the output convention below.

Return a success proportion using randomized or treated subjects. Require whole randomized >= treated >= 1 and treated >= assessed >= successes >= 0; denominator selects randomized/treated, proportion = successes/denominator, unassessedTreated = treated-assessed.1

An estimand specifies the treatment-effect question, including intercurrent-event handling. Denominator choices and missing-data assumptions must align with that question.2

Input fieldMeaning and unitsAccepted input
randomizedRandomizedRequired. Safe integer; minimum 1.
treatedTreatedRequired. Safe integer; minimum 1.
assessedAssessedRequired. Safe integer; minimum 0.
successesSuccessesRequired. Safe integer; minimum 0.
useRandomizedUse RandomizedRequired. Boolean.
Output fieldInterpretationReturned shape
denominatorDenominatorRequired. Safe integer.
proportionsuccesses divided by the chosen randomized/treated count, not assessed count.Required. Finite number.
unassessedTreatedUnassessed TreatedRequired. Safe integer.
json
{
  "input": {
    "randomized": 100,
    "treated": 90,
    "assessed": 80,
    "successes": 40,
    "useRandomized": true
  },
  "output": {
    "denominator": 100,
    "proportion": 0.4,
    "unassessedTreated": 10
  }
}

Limitations and assumptions

  • This is a supplied denominator convention, not a complete intention-to-treat, missing-data or estimand analysis.
  • 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-randomized-treated-denominator-choice — tool.io

  2. ICH E9(R1): estimands and sensitivity analysis — ICH

Similar or alternative tools