Randomised trial · 2 arms

CONSORT 2025 example: two-arm placebo trial

CONSORT 2025 flow diagram for a two-arm placebo trial, with reasons for exclusion, discontinuation, loss to follow-up and exclusion from analysis.

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Assessed for eligibility (n = 412)Excluded (n = 192)Not meeting inclusion criteria (n = 118)Declined to participate (n = 64)Other reasons (n = 10)Randomised (n = 220)Allocated to intervention (drug) (n = 110)Received allocated intervention (n = 108)Did not receive allocated intervention (n = 2)Withdrew consent before first dose (n = 2)Allocated to placebo (n = 110)Received allocated intervention (n = 109)Did not receive allocated intervention (n = 1)Withdrew consent before first dose (n = 1)Discontinued intervention (n = 10)Adverse events (n = 7)Lack of efficacy (n = 3)Lost to follow-up for primary outcome (n = 5)Moved away (n = 3)No reason given (n = 2)Discontinued intervention (n = 9)Adverse events (n = 3)Lack of efficacy (n = 6)Lost to follow-up for primary outcome (n = 6)Moved away (n = 2)No reason given (n = 4)Analysed for primary outcome (n = 104)Excluded from analysis (n = 1)No baseline measurement (n = 1)Analysed for primary outcome (n = 104)Excluded from analysis (n = 0)EnrolmentAllocationFollow-upAnalysis
Participant flow of a two-arm placebo-controlled trial in the CONSORT 2025 layout. Illustrative data.

About this example

The most common CONSORT diagram: 412 people assessed, 192 excluded before randomisation for three reasons, and 220 randomised in equal numbers to the drug and placebo. Only the assessed number, the reasons and the numbers allocated were typed; everything else is calculated.

Participants who stopped the drug because of adverse events stay in the analysis under intention to treat, so they appear under “Discontinued intervention” but are not subtracted from the number analysed. Only those lost to follow-up for the primary outcome, and one participant without a baseline measurement, are.

The data

Assessed for eligibility412
Excluded (reasons)Not meeting inclusion criteria (118), Declined to participate (64), Other reasons (10)
Randomised220
Arm: intervention (drug)allocated 110, lost to follow-up 5, analysed 104
Arm: placeboallocated 110, lost to follow-up 6, analysed 104

The totals were calculated in the editor from the numbers typed. Open the example, replace the data with your own, and export the figure as SVG, PDF, PNG or TIFF.

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