Tip of the Week - Template for Outcome Measure Results Data Tables
May 21, 2020
Use the table below to prepare your Outcome Measure data for entry into the Clinicaltrials.gov tabular results modules. Replace the italicized text with your values.
* = Required field
† = Values can be automatically copied over from what was already entered in the Protocol section of the record.
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*†¨Outcome Measure Type |
Primary Secondary Other Pre‐specified or Post‐Hoc |
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*¨†Outcome Measure Title |
(E.g. Change in Lesion Size) |
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¨†Outcome Measure Description |
(E.g. Lesion size will be measured in millimeters at baseline and week 2) |
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*†¨Outcome Measure Time Frame |
(E.g. Baseline, Week 2) |
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*¨†Arm/Group Title |
(E.g. Drug A) |
(E.g. Drug B) |
(E.g. Placebo) |
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¨†Arm/Group Description |
(E.g. Drug A, 20mg taken orally daily) |
(E.g. Drug B, 20mg taken orally daily) |
(E.g. Placebo, 20mg taken orally daily) |
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*# Participants Analyzed |
(# participants analyzed in that arm for this outcome) |
(#) |
(#) |
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Analysis Population Description |
(if the # of participants analyzed in each arm for this outcome measure differs from the # of participants analyzed in each arm, explain why here) |
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*Measure Type
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*Measure of Dispersion/Precision
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[*]Category Title |
(e.g. Baseline) |
Value (measure of dispersion, e.g. St. Dev.) |
# (#.#) |
# (#.#) |
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[*]Category Title |
(e.g. Week 2) |
# (#.#) |
# (#.#) |
# (#.#) |
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*Unit of Measure |
(e.g. millimeters, count of participants, visits, score on a scale) |
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