February 2024 SOCRA Source Journal - Journal - Page 29
DG, Moher D, CONSORT
Group. Ann Intern Med.
2010;152(11):726-732). The
ClinicalTrials.gov Participant
Flow module is a tabular
version of a CONSORT flow
diagram and accommodates
a wide range of study
designs.
2. Baseline Characteristics
Information: The
ClinicalTrials.gov Baseline
Characteristics module is a
table of demographic and
baseline measures and data
collected for all participants
in a clinical study, organized
by arm or comparison
group. This information
allows readers to see
whether study participants
are similar across groups
and how the population
relates to patients in clinical
practice. It also establishes
context for the outcome
measures assessed in the
study.
3. Outcome measure and
statistical information: The
purpose of the ClinicalTrials.
gov Outcome Measures
and Statistical Analyses
module is to summarize
results data, by arm or
comparison group, for each
primary and secondary
outcome measure assessed
in the study. Data for other
pre-specified and post hoc
outcome measures can also
be reported. An outcome
measure is an assessment
used to determine the
effect of an experimental
variable (for example, an
intervention) on participants
in a study. In addition,
the results of scientifically
appropriate tests of
statistical significance for
each outcome measure
can be reported in this
module. The results for
each outcome measure are
presented in a table in which
the columns represent the
study's arms or comparison
(analysis) groups and the
rows present summarylevel data. Each statistical
analysis is similarly reported
in a table that immediately
follows the relevant
outcome measure.
4. Adverse Event
Information: The
ClinicalTrials.gov Adverse
Event Information module
includes three tables that
summarize anticipated
and unanticipated adverse
events:
• All-Cause Mortality—
All deaths, due to
any cause, that were
collected during the
study (required if the
Primary Completion
Date is on or after
January 18, 2017)
• Serious Adverse
Events—All serious
adverse events that were
collected during the
study
• Other (Not Including
Serious) Adverse
Events—Nonserious
adverse events that
were collected during
the study and that
exceeded a specified
frequency threshold (0–5
percent) in any arm or
comparison group
In the Adverse Event tables,
the columns represent the
arms/groups for which
adverse events are reported;
the same columns appear
in all three Adverse Event
tables. The first row in each
table presents the frequency
of occurrence of all events
of that type for each arm/
group. Additional rows in
the Serious Adverse Events
and Other (Not Including
Serious) Adverse Events
tables represent the Adverse
Event Terms and present
the frequency of occurrence
of each event for each arm/
group.
5. Limitations and Caveats:
Limitations and Caveats is
an optional module used
to describe any significant
limitations of a study. For
example, if the target
enrollment was not reached
and there was insufficient
power to measure the effect
of the intervention, that
information can be provided
in this module. When
describing the limitations
of a study, avoid using
language that could be
interpreted as written results
or conclusions.
6. Certain Agreements and
Results Point of Contact:
Certain Agreements module
is used to indicate whether
there is an agreement
between the sponsor of
the study and one or more
principal investigators (PIs)
that limits the ability of
investigators to discuss or
publish the results of the
study. The Results Point of
Contact module is used to
provide a point of contact
for scientific information
about the study results.
Registering Clinical Trials and
Submitting Results
ClinicalTrials.gov has two
websites: The public website
and the website for the
protocol registration and
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