Attachment 1

Attachment 1.pdf

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

Attachment 1

OMB: 0925-0586

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0925-0586 can be found here:

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ClinicalTrials.gov "Basic Results" Data Element Definitions
(DRAFT)
November 2011

The "basic results" data element definitions and requirements currently included in ClinicalTrials.gov represent the
National Institutes of Health's (NIH's) current thinking on this topic, and were developed in response to the
provision contained within FDAAA that required the Agency to develop a "basic results" databank within one year
of enactment. They do not create or confer any rights for or on any person and do not operate to bind NIH, the
Department of Health and Human Services or the public. NIH will interpret these "basic results" reporting
requirements in regulations or guidance to be issued at a later date. Prior to the issuance of draft regulations or
guidance for comment, comments on the existing ClinicalTrials.gov "basic results" data element definitions and
requirements are welcome and will be considered by the Agency in drafting a Notice of Proposed Rulemaking.
Comments should be addressed to [email protected]. Please include "Comments on ClinicalTrials.gov
Results Requirements" in the subject line.

*
[*]

Required by ClinicalTrials.gov
Conditionally required by ClinicalTrials.gov

(FDAAA) May be required to comply with US Public Law 110-85, Section 801

1. Results Point of Contact
clinical trial results.

* : Point of contact for scientific information about the posted

Name or Official Title : For the designated individual. Note that this may be a specific
person's name (e.g., Dr. Jane Smith) or a position title (e.g., Director of Clinical Trials)
Organization Name

* : Full name of the designated individual's organizational affiliation.

Phone : (or "Email" required) Office phone of the designated individual. Use the format 123456-7890 within the United States and Canada. Otherwise, provide the country code and phone
number.
ext. : Phone extension, if needed
Email

* : (or "Phone" required) Electronic mail address of the designated individual.

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: Information certifying whether there exists an agreement between
2. Certain Agreements
the sponsor or its agent and the principal investigators (unless the sponsor is an employer of the
principal investigators) that restricts in any manner the ability of the principal investigators (PIs),
after the completion of the trial, to discuss the results of the trial at a scientific meeting or any
other public or private forum, or to publish in a scientific or academic journal information
concerning the results of the trial. This does not include an agreement solely to comply with
applicable provisions of law protecting the privacy of participants.

Are all PIs Employees of Sponsor? (Y/N) : If all principal investigators are employees of the
sponsor, select "Yes" and skip the remaining questions. If any principal investigator (PI) is not
an employee of the sponsor, select "No" and answer the remaining questions.
Results Disclosure Restriction on PI(s)? (Y/N) [*] If there is an agreement between the
sponsor (or its agent) and any non-employee PI(s) that restricts the PI's rights to discuss or
publish trial results after the trial is completed, select "Yes" and select a "Restriction Type." Trial
completion is defined as the final date on which data were collected. (ie, the Study Completion
Date from the Protocol Data Elements)
If there are agreements with multiple non-employee PIs and there is a disclosure restriction on at
least one PI, select "Yes" and answer the remaining question. If there are varying agreements
with PIs, choose the type below that represents the most restrictive of the agreements (e.g., the
agreement with the greatest embargo time period).
PI Disclosure Restriction Type : Select one
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The only disclosure restriction on the PI is that the sponsor can review results
communications prior to public release and can embargo communications regarding trial
results for a period that is less than or equal to 60 days from the time submitted to the
sponsor for review. The sponsor cannot require changes to the communication and cannot
extend the embargo.
The only disclosure restriction on the PI is that the sponsor can review results
communications prior to public release and can embargo communications regarding trial
results for a period that is more than 60 days but less than or equal to 180 days from
the time submitted to the sponsor for review. The sponsor cannot require changes to the
communication and cannot extend the embargo.
Other disclosure agreement that restricts the right of the PI to discuss or publish trial
results after the trial is completed

Other Disclosure Restriction Type : If "Other disclosure agreement..." is selected, please
describe the type of agreement including any provisions allowing the sponsor to require changes,
ban the communication, or extend an embargo.
(Limit: 500 characters)

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: Progress of research participants through each stage of a trial in a
3. Participant Flow
tabular format, including the number of participants who dropped out of the clinical trial.
(Identical in purpose to a CONSORT flow diagram, but represented as tables.)
The tabular presentation may be separated into "periods," each of which comprises an interval of
trial activity. Each period consists of "milestones" for reporting numbers of participants at
particular points in time within that period.
Recruitment Details
Definition: Key information relevant to the recruitment process for the overall study, such as
dates of the recruitment period and types of location (e.g., medical clinic), to provide context.
(Limit: 350 characters)
Pre-assignment Details
Definition: Description of any significant events and approaches for the overall study (e.g., wash
out, run-in, transition) following participant enrollment, but prior to group assignment. For
example, an explanation of why enrolled participants were excluded from the trial before
assignment to groups.
(Limit: 350 characters)

Arm/Group
Definition: Arms or comparison groups in a trial
(Note that arm information from the protocol section will be copied into the results section the
first time results are created. After that, such information may be changed in the results section at
any time. However, any changes in the results section will not be reflected in the protocol section
- you will also need to update the protocol section, as appropriate.)

Period(s)
Definition: Discrete stages of a clinical trial during which numbers of participants at specific
significant events or points of time are reported. If only one period, use Overall Study for "Period
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Title."
There is no limit to the number of periods that may be used to describe a single trial. Each
subsequent period represents a trial stage following the previous period. That is, participants
"flow" from earlier to later periods. All results sections must cover participant flow from initial
assignment to arms/groups to completion of the trial.

Period Title
Definition: Title describing a stage of the trial. If only one period is defined, the default title is
"Overall Study." When a trial has more than one period, none of the period titles should be
"Overall Study." Example of two periods: sertraline then placebo; placebo then sertraline;
(Limit: 40 characters)

Milestone(s)
Definition: Specific events or time points in the trial when the numbers of participants are
reported. While there is no limit to the number of milestones that may be used in a single period,
data are required for two milestones, STARTED and COMPLETED, within each period.
STARTED

* : Number of participants at the beginning of the period.

Comments : Additional information about the STARTED milestone.
(Limit: 100 characters)
COMPLETED

* : Number of participants at the end of the period.

Comments : Additional information about the COMPLETED milestone.
(Limit: 100 characters)
[Not Completed : Number of participants that did not complete the period. Calculated
automatically by subtracting COMPLETED from STARTED]
Additional Milestone(s) : Any number of milestones may be added between the two required
milestones, STARTED and COMPLETED.
Milestone Title: [*] : Label describing milestone
(Limit: 40 characters)
Milestone Data [*] (per milestone, per arm/group): Number of participants to reach the
milestone.
Comments : Additional information about the milestone.
(Limit: 100 characters)

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Reason Not Completed : Additional information about participants who did not complete the
period. If any are provided, the total number of participants accounted for by all reasons must
equal the number of participants listed under "Not Completed."
Reason Not Completed Type [*] : Select one for each reason not completed
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Adverse Event
Death
Lack of Efficacy
Lost to Follow-up
Physician Decision
Pregnancy
Protocol Violation
Withdrawal by Subject
Other

Other Reason [*] : If "Other" is selected, provide label
(Limit: 40 characters)
Reason Not Completed Data [*] (per reason, per arm/group): Number of participants for each
arm or comparison group.

4. Baseline Characteristics
: A table of demographic and baseline data for the entire trial
population and for each arm or comparison group. Note that only baseline measures for Age and
Gender are required; all other baseline measures are optional. The table cells accommodate
different types of data:
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Categorical - create customized categories and then report a count or a measure of central
tendency and a measure of dispersion for each category by arm or comparison group
Continuous - report a measure of central tendency and a measure of dispersion for each
arm or comparison group
Time-to-Event Data - report as either (1) continuous data (e.g., mean time to event with
measure of dispersion) or (2) categorical data at different time points by arm or
comparison group

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any time. However, any changes in the results section will not be reflected in the protocol section
- you will also need to update the protocol section, as appropriate.)

Overall Number of Baseline Participants
(per arm/group) : Overall number of participants
for which baseline characteristics were measured for all baseline measures reported. Note that if
the participant population differs for a particular baseline measure, the number of participants
should be included in the Baseline Measure Description.

Baseline Measure(s)
Definition: Name and description of a characteristic measured at the beginning of the trial. Note
that baseline measure data for "Age" (at least one of the three types) and "Gender" are required.
There is no limit to the number of additional "Study-Specific Measures" that may be provided.

Baseline Measure Title
: Select one. Note that baseline measures for at least one "Age" and
"Gender" title are required.
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Study-Specific Measure (as many as needed)

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Age

* (at least one of the following):

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Gender
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Age, Continuous: example - mean age in years
Age, Categorical:
• <=18 years
• >18 and <65 years
• >=65 years
Age, Customized: example - number in each category
(birth-10 years, 11-20 years, 21-30 years, etc.)

* (one of the following):
Gender, female, male
Gender, Customized

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Race (NIH/OMB): U.S. National Institutes of Health and U.S. Office of Management and
Budget Classification Categories
Race, Customized
Ethnicity (NIH/OMB): U.S. National Institutes of Health and U.S. Office of Management
and Budget Classification Categories
Ethnicity, Customized
Region of Enrollment

Study-Specific Baseline Measure Title(s) [*] : If "Study-Specific Measure" is chosen, provide
the name of the measure. Examples: Systolic blood pressure; Prior anti-depressant treatment.
(Limit: 100 characters)
Baseline Measure Description : Additional information about the measure, such as details
about the collection method or participant population, if different from Overall Number of
Baseline Participants.
(Limit: 600 characters)
Measure Type
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* : Select one

Number (e.g., number of participants)
Measure of Central Tendency, if a continuous measure is reported
• Mean
• Median
• Least Squares Mean
• Geometric Mean
• Log Mean

: Select one. Please select "Not Applicable" if the Measure Type is
Measure of Dispersion
"Number". Please do NOT select "Not Applicable" for other measure types.
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Not Applicable
Standard Deviation
Inter-Quartile Range
Full Range

Unit of Measure : e.g., participants, mm Hg
(Limit: 40 characters)

Category Title : (required for categorical data)
Definition: Name of distinct category for a baseline measure, if reporting categorical data.

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(Limit: 50 characters)

: (per baseline measure and per arm/group)
Baseline Measure Data
Definition: Baseline measure data (either "Number" or "Descriptive Statistics").
Number

* : (or Descriptive Statistics): e.g., number of participants

Descriptive Statistics

* : (or Number)

Central Tendency Value : mean, median, least squares mean, geometric mean, or log mean.
Dispersion Value(s) : standard deviation, inter-quartile range, or full range.
NA (Not Available) Explanation [*] - required when NA is reported. : Explain why baseline
measure data (i.e., any "Number" or "Descriptive Statistics" value) are Not Available.
(Limit: 250 characters)

: A table of values for each of the outcome measures by arm (i.e.,
5. Outcome Measures
initial assignment of groups to interventions) or comparison group (i.e., groups receiving
interventions regardless of initial assignment). The table cells accommodate different types of
data:
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Note that data reported for each outcome measure will be displayed as a separate table. All
statistical analyses on those data will be associated with that table.

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* (per outcome measure, per arm/group)

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; see Type of Units Analyzed.
Analysis Population Description
Definition: Explanation of how the number of participants 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
Definition: Name and description of the measure used to assess the effect of experimental
variables in the trial
(Note that primary and secondary outcome measure information from the protocol section of the
record will be copied into the results section the first time results are created. After that,
"Outcome Measure Type," "Outcome Measure Title," "Outcome Measure Time Frame" and
"Outcome Measure Safety Issue? (Y/N)" for primary or secondary outcome measures may only
be changed in the results section.)
Outcome Measure Type
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* : Select one

Primary Outcome Measure (from Protocol section)
Secondary Outcome Measure (from Protocol section)
Other Pre-specified Outcome Measure

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Post-Hoc Outcome Measure

Outcome Measure Reporting Status
: Indicate whether posting results data for this outcome
measure. Note that each record is required to have "Posted" data for at least one outcome
measure.
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Posted: Results data included
Not Posted: Results data not included

Anticipated Posting Date : If "Outcome Measure Reporting Status" is "Not Posted", then
indicate the expected month and year it will be "Posted."
Outcome Measure Title
(Limit: 255 characters)

* : Name of outcome measure

Outcome Measure Time Frame
(Limit: 255 characters)

* : Time point(s) at which outcome measure was assessed.

Outcome Measure Description: Additional information about outcome measure.
(Limit: 600 characters)
Outcome Measure Safety Issue? (Y/N) (FDAAA) : Is this outcome measure assessing a safety
issue? Select: Yes/No
Measure Type
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* : Select one

Number (e.g., number of participants)
Measure of Central Tendency, if a continuous measure is reported
• Mean
• Median
• Least Squares Mean
• Geometric Mean
• Log Mean

Measure of Dispersion/Precision
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* : Select one.

Not Applicable (only when Measure Type is "Number")
Standard Deviation

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Inter-Quartile Range
Full Range
Standard Error
95% Confidence Interval
90% Confidence Interval
Geometric Coefficient of Variation (only when Measure Type is "Geometric
Mean")

Unit of Measure : e.g., participants, mm Hg
(Limit: 40 characters)
Type of Units Analyzed [*] - required when "Number of Units Analyzed" are reported. :
If analysis is not based on participants, specify the type of units analyzed (e.g., eyes, lesions,
implants); see Number of Units Analyzed.
(Limit: 40 characters)

Category Title : (required for categorical data, as many as needed)
Definition: Name of distinct category used to measure outcome, if reporting categorical data.
(Limit: 50 characters)

Outcome Data
: (per category, per arm/group)
Definition: Outcome measure summary data (either "Number" or "Descriptive Statistics").
Number

* : (or Descriptive Statistics): e.g., number of participants

Descriptive Statistics

* : (or Number)

Central Tendency Value : mean, median, least squares mean, geometric mean, or log mean
Dispersion Value(s) : standard deviation, inter-quartile range, full range, standard error, 95%
confidence interval, or 90% confidence interval
NA (Not Available) Explanation [*] - required when NA is reported. : Explain why
outcome data (i.e., any "Number" or "Descriptive Statistics" value) 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)
Statistical Analyses - OPTIONAL; if statistical analysis information is provided, then [*]marked data elements are required.

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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") or superiority (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.
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ANCOVA
ANOVA
Chi-squared
Chi-squared, Corrected
Cochran-Mantel-Haenszel
Fisher Exact
Kruskal-Wallis
Log Rank
Mantel Haenszel
McNemar
Mixed Models Analysis
Regression, Cox

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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
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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

Other Parameter Name [*] : If "Other" is selected, provide name
(Limit: 40 characters)
Estimated Value [*] (if provided, Estimation Parameter required)
Confidence Interval [*] (if applicable, provide the following sub-elements):
Level [*] : Expressed as a percentage. (Default "95").
Number of Sides : Select 1-sided or 2-sided (default).

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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
Parameter Dispersion Type : Select one.
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Standard Deviation
Standard Error of the Mean

Dispersion Value
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)

6. Overall Limitations and Caveats : If appropriate, describe significant limitations of the trial.
Examples: Early termination leading to small number of subjects analyzed; Technical problems
with measurement leading to unreliable or uninterpretable data.
(Limit 250 characters)
7. Adverse Events

* : Two types of adverse event data are to be reported

1. Serious Adverse Events: A table of all anticipated and unanticipated serious adverse
events, grouped by organ system, with number and frequency of such events in each arm
of the clinical trial. (See Adverse Events definition below).
2. Other (Not Including Serious) Adverse Events: A table of anticipated and unanticipated
events (not included in the serious adverse event table) that exceed a frequency threshold
within any arm of the clinical trial, grouped by organ system, with number and frequency
of such events in each arm of the clinical trial.

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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)
Time Frame for Adverse Event Reporting
Definition: Period in which the reported adverse event data were collected (e.g., 1 year, 6
months)
(Limit: 255 characters)
Adverse Event Reporting Additional Description
Definition: Additional relevant information about adverse event collection, including details
about the method of systematic assessment (e.g., daily questionnaire)
(Limit: 350 characters)
Source Vocabulary Name for Table Default
Definition: Default value for Source Vocabulary Name to be applied to all adverse event terms
entered in the "Serious" and "Other" adverse event tables, unless otherwise specified (e.g.,
SNOMED CT, MedDRA 10.0).
(Limit: 20 characters)
Assessment Type for Table Default
Definition: Default value for Adverse Event Assessment Type (Systematic or Non-Systematic
Assessment Type) to be applied to all adverse event terms entered in the "Serious" or "Other"
adverse event tables, unless otherwise specified.
Adverse Events
Definition: Unfavorable changes in health, including abnormal laboratory findings, that occur in
trial participants during the clinical trial or within a specified period following the trial.
Two types of adverse event data are to be reported: "Serious" and "Other (Not Including
Serious)" adverse events.

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1. Serious Adverse Events include adverse events that result in death, require either
inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result
in a persistent or significant disability/incapacity or result in a congenital anomaly/birth
defect. Other important medical events, based upon appropriate medical judgment, may
also be considered Serious Adverse Events if a trial participant's health is at risk and
intervention is required to prevent an outcome mentioned.
2. Other (Not Including Serious) Adverse Events are those that are not Serious Adverse
Events that exceed a frequency threshold.

* : Word or phrase describing an adverse event.

Adverse Event Term
(Limit: 100 characters)

Source Vocabulary Name : Standard terminology, controlled vocabulary, or classification and
version from which adverse event terms are drawn, if any (e.g., SNOMED CT, MedDRA 10.0).
Leave blank to indicate that the value specified as the Source Vocabulary for Table Default
should be used.
(Limit: 20 characters)

Organ System : High-level categories used to group adverse event terms by body or organ
system. Select one. Adverse events that affect multiple systems should be classified as "General
disorders."
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Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Nervous system disorders
Pregnancy, puerperium and perinatal conditions
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders

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Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

Assessment Type : Method used to assess the adverse event. Select one or leave blank to
indicate that the value specified as the Assessment Type for Table Default should be used.
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Systematic Assessment: Any method of routinely determining whether or not certain
adverse events have occurred, for example through a standard questionnaire, regular
investigator assessment, regular laboratory testing, or other method
Non-systematic Assessment: Any non-systematic method for determining whether or not
adverse events have occurred, such as self-reporting by participants or occasional
assessment/testing

Adverse Event Term Additional Description : Additional relevant information about the
adverse event, including any deviation from the Time Frame for Adverse Event Reporting.
(Limit: 250 characters)

Total Number Affected by Any Serious Adverse Event (per arm/group): Overall number of
participants affected by one or more Serious Adverse Events.

Total Number of Participants at Risk for Serious Adverse Event (or Number of
Participants at Risk for each Serious Adverse Event Term required)
(per arm/group) : Overall number of participants included in the assessment of serious adverse
events during the trial (i.e., the denominator for calculating frequency of serious adverse events)

Frequency Threshold for Reporting Other (Not Including Serious) Adverse Event
The frequency of Other (Not Including Serious) Adverse Events that, when exceeded within any
arm or comparison group, are reported in the results database for all arms or comparison groups.
The number must be less than or equal to the allowed maximum (5%), and must not include any
symbols (e.g., >= , %).
Expressed as a percentage.
For example, a threshold of 5 percent indicates that all Other (Not Including Serious) Adverse
Events with a frequency greater than 5 percent within at least one arm or comparison group are
reported.
Total Number Affected by any Other (Not Including Serious) Adverse Event above the
Frequency Threshold

* (per arm/group): Overall number of participants affected by one or
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more Other (Not Including Serious) Adverse Events above the specified Frequency Threshold
(e.g., 5%) reported in the table.

Total Number of Participants at Risk for Other (Not Including Serious) Adverse Event
(or Number of Participants at Risk for each Other, Not Including Serious, Adverse Event Term
required)
(per arm/group) : Overall number of participants included in the assessment of other, not
including serious, adverse events during the trial (i.e., the denominator for calculating frequency
of other, not including serious, adverse events).

Adverse Event Data

* (per adverse event, per arm/group)

Number of Affected Participants
being reported

* : Number of participants experiencing at least one event

Number of Events: Number of occurrences of the adverse event being reported

Number of Participants at Risk
: Number of participants assessed for adverse events during
the trial (i.e., the denominator for calculating frequency of adverse events). Leave blank to
indicate that the value specified as the total at risk in the arm/group for the table should be used.
Note, when the number at risk in the arm/group is blank, the total at risk in the arm/group for the
table must be entered.

Delayed Results Posting - OPTIONAL: If delayed results posting information is provided, then
all [*]-marked data elements are required, except as noted below.
Definition: Information to be provided when (1) delaying submission of results with certification
or (2) requesting an extension of the deadline for submitting results in accordance with U.S.
Public Law 110-85, Title VIII, Section 801. The information provided may be displayed publicly
as part of the protocol record.
Delay Results Type [*] : Select one
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Results Not Required - not subject to US Public Law 110-85, Title VIII, Section 801
(FDAAA)
Certify Initial Approval - seeking initial FDA approval of a drug, biological product, or
device
Certify New Use - seeking FDA approval of a new use for the drug or device
Extension - requesting an extension of the deadline for the submission of results
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Intervention Name(s) [*] : Required when Delay Results Type is "Certify Initial Approval" or
"Certify New Use."
Provide the name of one or more drugs, biological products, or devices for which approval
("initial" or "new use") is being sought. For drugs use generic name; for other types of
interventions provide a brief descriptive name. The name(s) entered should match Intervention
Name(s) provided in the protocol record.
FDA Application Number(s):
Provide at least one FDA application number (e.g., NDA, BLA, or PMA number), if available,
when Delay Results Type is "Certify Initial Approval" or "Certify New Use."
Requested Submission Date [*] : Required when Delay Results Type is "Extension."
Provide the month and year when results are to be submitted.
Explanation [*] : Required when Delay Results Type is "Extension."
Provide a detailed justification for the extension. The justification must contain sufficient
information to allow for evaluation of the request. Note that "pending publication" is not
considered "good cause" for an extension.
Reminder: The explanation may be made public on ClinicalTrials.gov as part of the protocol
record.
(Limit: 600 characters)

File Type	application/pdf
File Modified	2012-01-23
File Created	2012-01-23