Definition: Name and description of the measure used to assess the effect of experimental variables in the trial
Note that outcome measure information from the protocol section of the record will be copied into the results section
the first time results are created.
Outcome Measure Type
*
: Select one
- Primary
- Secondary
- Other Pre-specified
- Post-Hoc
Outcome Measure Title
*
: Name of outcome measure
(Limit: 255 characters)
Outcome Measure Description: Additional information about outcome measure.
(Limit: 999 characters)
Outcome Measure Time Frame
*
: Time point(s) at which outcome measure was assessed.
(Limit: 255 characters)
Outcome Measure Safety Issue? (Y/N)
(FDAAA)
: Is this outcome measure assessing a safety issue? Select: Yes/No
[
Outcome Measure Reporting Status
*
: Indicates whether results data are included for this outcome measure.
Determined automatically based on whether the Outcome Measure Data are included.
Note that each record is required to have results data submitted for at least one primary outcome measure.]
Anticipated Reporting Date:
If results data are not included for an outcome measure, provide the expected month and year they will be submitted.
Arm/Group
*
Definition: Arms or comparison groups in a trial
Arm/Group Title
*
: Label used to identify the arm or comparison group.
Minimum length is 4 characters. Titles shorter than the minimum are unlikely to sufficiently describe the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: >=4 and <=62 characters)
Arm/Group Description:
Brief description of the arm or comparison group to distinguish it from other arms/groups in the trial.
Examples: fluoxetine, 20mg qhs; Sirolimus-eluting stent (SES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach.
(Limit: 999 characters)
Number of Participants Analyzed
*
(per outcome measure, per arm/group)
For the outcome reported
Type of Units Analyzed
[*]
If analysis is not based on participants, specify the type of units analyzed (e.g., eyes, lesions, implants).
(Limit: 40 characters)
Number of Units Analyzed
[*] - required when "Type of Units Analyzed" is reported
(per outcome measure, per arm/group)
For the outcome data reported, the number of units analyzed when analysis is not based on participants.
Analysis Population Description
Definition: Explanation of how the number of participants (or units) for analysis was determined. Indicate whether the analysis was "per protocol", "intention to treat (ITT)", or another method. Also provide relevant details such as imputation technique (e.g., Last Observational Carried Forward [LOCF]), as appropriate.
(Limit: 350 characters)
Outcome Measure Data Table
Measure Type
*
: Select one
- Count of Participants
- Mean
- Median
- Least Squares Mean
- Geometric Mean
- Number
- Count of Units
Measure of Dispersion/Precision
*
: Select one.
- Not Applicable (only when Measure Type is "Number", "Count of Participants", or "Count of Units")
- Standard Deviation
- Standard Error
- Inter-Quartile Range
- Full Range
- Geometric Coefficient of Variation (only when Measure Type is "Geometric Mean")
- 80% Confidence Interval
- 90% Confidence Interval
- 95% Confidence Interval
- 97.5% Confidence Interval
- 99% Confidence Interval
- Other Confidence Interval Level
Other Confidence Interval Level
[*] - required when "Other Confidence Interval Level" is selected
: Specify the numerical value for the confidence interval level. Provide a rationale for choosing this level in the Outcome Measure Description.
Category or Row Title
*
:
Definition: Name of distinct category or row for an outcome measure.
Category Titles are only for mutually exclusive and exhaustive categories.
Row titles are for any type of data.
(Limit: 50 characters)
Number of Participants Analyzed
(per arm/group and row) : The number of participants analyzed for the Outcome Measure in the row, if different from the overall Number of Participants Analyzed.
Number of Units Analyzed
(per arm/group and row) : The number of units analyzed for the Outcome Measure, if different from the overall Number of Units Analyzed.
Outcome Data
*
: (per category/row, per arm/group)
Definition: The measurement value(s) for each outcome measure.
NA (Not Available) Explanation
[*] - required when NA is reported.
: Explain why outcome data are Not Available.
Example: (Time-to-event outcome) The upper limit of the 95% confidence interval was not calculable because
an insufficient number of participants reached the event at the final time point for assessment.
(Limit: 250 characters)
Unit of Measure
*
: e.g., participants, mm Hg
(Limit: 40 characters)
Statistical Analyses - OPTIONAL; if statistical analysis information is provided, then
[*]-marked data elements are required.
Definition: One or more statistical analyses conducted on the outcome data.
If a statistical analysis is reported, the following data elements are required: "Comparison Group Selection," "Non-inferiority or Equivalence Analysis," and at least "P-Value" or "Confidence Interval" with the associated information.
Statistical Analysis Overview:
Summary description of the analysis performed.
Comparison Group Selection
[*]
: Identifies the arms or comparison groups involved in the statistical analysis (check all to indicate an "omnibus" analysis)
Comments:
Additional details about the statistical analysis, such as null hypothesis and description of power calculation
(Limit: 500 characters)
Non-inferiority or Equivalence Analysis? (Y/N)
[*]
: Identifies whether the analysis is a test of non-inferiority or equivalence (choose "Yes").
(For other types of analyses, including superiority or single-group, choose "No").
Comments
[*]
: If, "Yes", provide additional details, including details of the power calculation (if not previously provided), definition of non-inferiority margin, and other key parameters
(Limit: 500 characters)
Statistical Test of Hypothesis:
Procedure used for statistical analysis of outcome data and calculated p-value.
P-Value
[*]
: (if applicable): Calculated p-value given the null-hypothesis
Comments:
Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the
a priori threshold for statistical significance
(Limit: 250 characters)
Method
[*]
: (required if "P-Value" is reported): Select a statistical test.
- ANCOVA
- ANOVA
- Chi-squared
- Chi-squared, Corrected
- Cochran-Mantel-Haenszel
- Fisher Exact
- Kruskal-Wallis
- Log Rank
- Mantel Haenszel
- McNemar
- Mixed Models Analysis
- Regression, Cox
- Regression, Linear
- Regression, Logistic
- Sign Test
- t-Test, 1-sided
- t-Test, 2-sided
- Wilcoxon (Mann-Whitney)
- Other
Other Method Name
[*]
: If "Other" is selected, provide name of statistical test.
(Limit: 40 characters)
Comments:
Any other relevant information, such as adjustments or degrees of freedom
(Limit: 150 characters)
Method of Estimation:
Procedure used to estimate effect of intervention.
Estimation Parameter
[*]
: Select one
- Cox Proportional Hazard
- Hazard Ratio (HR)
- Hazard Ratio, log
- Mean Difference (Final Values)
- Mean Difference (Net)
- Median Difference (Final Values)
- Median Difference (Net)
- Odds Ratio (OR)
- Odds Ratio, log
- Risk Difference (RD)
- Risk Ratio (RR)
- Risk Ratio, log
- Slope
- Other
Confidence Interval
[*]
(if applicable, provide the following sub-elements):
Level
[*]
: Expressed as a percentage.
Number of Sides:
Select 1-sided or 2-sided.
Lower Limit
[*]
: (required if confidence interval is 2-sided or if confidence interval is 1-sided and no Upper Limit is entered.)
Upper Limit
[*]
: (required if confidence interval is 2-sided or if confidence interval is 1-sided and no Lower Limit is entered.)
NA (Not Available) Explanation
[*]
: (required when NA is reported as upper-limit of 2-sided confidence interval.)
Explain why the upper limit data are Not Available.
Example: (Time-to-event outcome) The upper limit of the 95% confidence interval was not calculable because an insufficient
number of participants reached the event at the final time point for assessment.
(Limit: 250 characters)
Dispersion of Confidence Interval
Estimation Comments:
Any other relevant estimation information, including the direction of the comparison (e.g., describe which arm or comparison group represents the numerator and denominator for relative risk)
(Limit 250 characters)