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Two-Sample Poisson Rates Sample Size

Calculates the required sample size per group for a two-sided or one-sided large-sample Z-test comparing two independent Poisson event rates. Based on the large-sample method documented in the statistical literature from Mathews (2010). Runs entirely in your browser.

Study Assumptions

Enter the expected event rates, desired power, significance level, and common observation time.

Required Sample Size

The calculation uses the closed-form large-sample Z approximation and rounds each group size up to the next whole subject.
Enter the study assumptions and click Calculate Sample Size.

Methodology

This calculator implements the large-sample Z-test for the difference between two independent Poisson event rates described in this method Chapter 436, which cites Paul Mathews (2010), Sample Size Calculations: Practical Methods for Engineers and Scientists. this method defines the event-rate difference as λ₂ − λ₁ and describes the two-sided large-sample test as appropriate when the observed event counts are sufficiently large.

Sample Size Formula

For equal sample sizes and a common observation time t per subject, the required number of evaluable subjects per group is

N = ceil{ [(z1−α/2 + zpower)² (λ₁ + λ₂)] / [t(λ₂ − λ₁)²] }

For a one-sided test, z1−α/2 is replaced by z1−α. The formula follows directly from the large-sample power expression documented in the statistical literature: the standard error of the estimated difference is √[λ₁/(N₁t) + λ₂/(N₂t)], which reduces to √[(λ₁ + λ₂)/(Nt)] under equal allocation.

What the Inputs Mean

Worked Validation Example

this method Chapter 436, Example 1, uses λ₁ = 1, λ₂ = 1.1, 90% power, α = 0.05, a two-sided large-sample test, and equal allocation. This yields N₁ = 2,207 and N₂ = 2,207, for a total of 4,414 subjects.

Raw calculation: N = 2206.5588… → N₁ = N₂ = 2207 → total N = 4414

The calculator reproduces this result before the displayed sample size is rounded upward. The achieved power at the rounded sample size is also reported in the results panel.

Assumptions and Limitations

The method assumes independent Poisson counts, fixed observation time, and a sufficiently large-sample approximation. Note that its large-sample Z-test is appropriate when the event counts are large (it specifically states Xi > 30 for this test). If expected event counts are small, overdispersion is present, follow-up times differ materially between subjects, or clustering or repeated observations are important, a different sample-size method may be needed.

References

Mathews, P. (2010). Sample Size Calculations: Practical Methods for Engineers and Scientists. Mathews Malnar and Bailey, Fairport Harbor, Ohio. This is the source cited by this method for the large-sample Poisson-rate difference method.

the software, LLC. this method Sample Size Software: Tests for the Difference Between Two Poisson Rates, Chapter 436. This method uses the large-sample Z-test, its power equation, and the validation example used above.

Statsols. . provides sample-size and power procedures for Poisson/incidence-rate designs, including two-rate comparisons and normal-approximation approaches.

Clinical Trials

Real trials behind this calculation

See the analysis this calculator plans for applied to published trial results, with the estimates, confidence intervals and interpretation explained.

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Independent statistical analysis of the DISCOVER phase 3 trial evaluating F/TAF versus F/TDF for HIV-1 pre-exposure prophylaxis, including non-inferiority testing, rate-ratio analysis,…
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INVIGORATE
Independent statistical analysis of Exacerbation Study: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…
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