Learn how to read study results in records posted on BMU CTR. Results include information about the study’s participant flow, baseline characteristics, outcome measures, and adverse events.
The study results provided in a BMU CTR record are not meant to be interpreted without help from an expert. Interpreting study results is complex because many factors can influence their meaning. For more information about the results of a specific study, contact the Results Point of Contact found in the Summary results section.
You can search for clinical studies with results by using filters on the BMU CTR home page or the Search Results page. See How to search for studies with results.
Overview
The Summary results section of a study record can include these main parts:
- Results Overview - general information about the study
- Participant Flow - the progress of participants through the overall study
- Baseline Characteristics - the data that researchers collected at the start of the study about all the participants
- Outcome Measures - the data collected about participants during the study
- Adverse Events - any unfavorable change in health that happened to participants during the study
- Limitations and Caveats - explanations of anything that might have impacted the quality or reliability of the study results, if provided
Helpful features
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Where to find results in a study record
When you open a study record, scroll down to the Summary results section, after the Ethics section.
If the study record has a Summary results section, the study has results posted.
If there is no Summary results section, results have not been posted. Results are posted only after they have been submitted and have passed quality control (QC) review by the Registry Office. To find studies whose results have been submitted but are still under QC review, use the Results submitted filter (see How to search for studies with results). A study may not have results posted because the study isn't done or because results have not yet been submitted.
When results are posted, they are added to the record as a new version, which you can see in the record's History of changes.
Sections of the study results
If results have been posted, you will see these possible parts in the Summary results section:
- Results Overview
- Participant Flow
- Baseline Characteristics
- Outcome Measures
- Adverse Events
- Limitations and Caveats
Results Overview
This part includes general information about the study. You may find:
- Conditions - the disease, disorder, syndrome, illness, or injury that was studied
- Intervention/Treatment - the drug, device or action that was studied
- Other Study ID Numbers - any identification numbers assigned to a study record other than the BDCTR ID
- Study Design - the details about how the study was set up to answer the study questions
- Results Point of Contact - the name and contact information for the person who can answer questions about the study results
- Enrollment - the number of participants who were in the study
- Study Type - whether the study was interventional (participants were assigned to treatments) or observational (participants were not assigned to treatments)
Participant Flow
This part shows the progress of participants through the overall study.
At the top are fields for Recruitment Details and Pre-assignment Details. These fields can explain where participants were from and what happened to participants who were enrolled in but did not start the study.
If there was more than one arm or group, each one is shown in a different column at the top of the Participant Flow table.
Each period of the study has its own table which shows the progress of participants through certain stages of the study. The header shows the title for the period.
In the period table, you’ll find the number of people in each arm or group who started, completed, and did not complete each period. There may also be rows that provide more information about the participants and that list the reasons participants did not complete the study. For example, a table may show the participants who "Received Intervention and Completed Baseline Assessments" as well as the reasons that some participants did not complete the study (under the Reason Not Completed heading row).
Baseline Characteristics
This part shows the data that researchers collected about all participants at the start of the study. Baseline Characteristics may include:
- Age
- Sex or Gender
- Race
- Ethnicity
- Study-Specific Measures - the baseline data for the study’s primary outcome measures, or baseline data for other measures unique to the study, for example, blood pressure, height, or weight
- Region of Enrollment - including the number of participants in different countries who took part in the study
The first table shows the arm or group names, descriptions, and the number of people whose data were collected at the start of the study.
If there was more than one arm or group, each one is shown in a different column in the table. There is also a Total column for participants in all groups.
Each baseline characteristic has a table that includes the baseline measurement data. Each table has a header with the name of the baseline characteristic, the type of data collected, and the unit of measure. For example, the name of the baseline characteristic may be "Age, Continuous," the type of data "Mean (Standard Deviation)," and the unit of measure "years." Such a table might show that there were 72 participants in the Group 1 (Active TENS) arm, and their average age was 62.6 years, plus or minus 8.6 years.
Outcome Measures
This part shows the data that researchers collected about participants during the study.
Each Outcome Measure table has a heading row with the name of the outcome measure; whether it was a primary, secondary, or other measure; and the timeframe when the measure was taken. Each outcome measure is numbered. The rows below the heading row may include descriptions of the outcome measure and the participants who were studied.
The rest of the table shows the number of participants included in the measure and the data that were collected. If there was more than one arm or group, each one is shown in a different column in the table.
Statistical Analysis tables
Some outcome measures include statistical analysis tables. Statistical analysis involves mathematical formulas and calculations that help researchers make decisions and draw conclusions about the data from a clinical study.
Adverse Events
This part summarizes the number and type of Adverse Events that happened to participants in the study, including:
- All-Cause Mortality - how many people in each arm died for any reason during the study
- Serious Adverse Events - events that caused death or were life-threatening
- Other (Not Including Serious) Adverse Events - adverse events that are not considered serious
Adverse events are shown in tables organized by type (named in the heading rows). Tables showing general information appear first.
The first table shows the time frame during which the researchers tracked adverse events. There may also be a description of how the information was collected. The next table shows the title of each arm or group in the study and a description of that arm or group. If there was more than one arm or group, each one is shown in a different column in the tables that follow.
The next table, All-Cause Mortality, shows how many participants died during the study. In this table, and in the ones that follow, the total number of participants affected (who had the adverse event happen to them) and the number at risk (who could have had the adverse event happen) is shown for each arm or group.
The final two tables show serious and other adverse events. Events in these tables are organized by the organ systems that were affected, shown in heading rows. The number of participants affected and the number at risk in each arm or group is shown for each event.
For example, in a Serious Adverse Events table, the adverse event Disease Progression would be listed under the General disorders heading.
In the Other (Not Including Serious) Adverse Events table, the first row shows the frequency threshold for reporting other adverse events, a number that ranges from 0% to 5%. If the threshold is 0%, it means that the table includes all other adverse events. If the threshold is greater than 0%, it means that the table includes only adverse events that happened at or above that percentage of participants in any arm or group. Non-serious adverse events that occur at a frequency of 5% or greater in any single arm or group must be included in the Other (Not Including Serious) Adverse Events table.
Limitations and Caveats
This part may show any limitations or caveats the study had. Limitations and Caveats may explain:
- Any events that could have affected the quality of the results
- Why a study was not completed as planned
- Why recruitment or enrollment ended early
The sponsor, collaborators and investigators are shown in the Sponsor & contacts section of the study record, and every published version of the record, including the version that added the results, is listed in its History of changes section. See How to Read a Study Record.