Cross-classify the binary exposure against the binary outcome . The four cells count placebo survivors or deaths and active-treatment survivors or deaths.
Under the sharp causal null hypothesis, every observed outcome equals the fixed value , regardless of assignment. With fixed arm sizes, the active set is a uniformly chosen subset of size . Under independent assignment, are independent Bernoulli variables with probability , and conditioning on their total again makes the active set uniform. Conditional on the table margins, the active-group outcome count therefore has exactly the hypergeometric distribution used by Fisher's exact test.
The conditional p-value is super-uniform for every set of margins. The law of total probability then gives
Hence the test is valid under either assignment mechanism.
For a two-by-two contingency table, Fisher's exact test conditions on both row totals and both column totals. Under the null of no association, the upper-left count then has the hypergeometric distribution
where and are the first row and column totals. A one-sided p-value sums the appropriate hypergeometric tail; a common two-sided p-value sums the probabilities of all feasible tables no more likely under the null than the observed table. Because the conditional distribution is discrete, the p-value is super-uniform random variable rather than generally exactly uniform.