In this section Hide
On the Drug-Event Combinations page, you can view the statistical information about each drug-event combination, including the EBGM and PRR for each drug-event combination, over cumulative time periods. In addition, the page contains information that your organization chose to include (for example, trending information about changes in the statistics over time). This information varies depending on how signal management has been configured for your organization. For a drug-event combination, you can access information that can help determine causal association. For example, you can view age and gender distribution, reporting frequency, and combinations for the same HLT, HLGT, or SOC.
Note: The drug-event combinations can include custom terms and terms from the source data.
If, for a drug-event combination, there are statistics from multiple signal sets, the statistics columns typically have names that identify the signal sets. If signal management is integrated with topics, the table includes columns for Topic Name and Topic State.
Note: Statistics, such as EBGM and PRR, are provided for the signal sets and time periods. If there is no value of N for the signal set and time period, no statistics are available.
For more information, see Available drug-event combination statistics.
The following links appear at the top of the page and affect the entire page:
The following links appear at the top of the page when the page is in the Select Rows mode. The links affect the selected drug-event combinations:
The following filters appear at the top of the page and affect the entire page.
You can limit the drug-event combinations that appear in the table by using the filters. For example, you might want to see only drugs that are assigned to you for review, or only one drug. You can set user preferences for default values to appear in the Group, Reviewer, and Drug filters. If you select a drug group, the Reviewer and Drug filters are affected as follows:
In the Group, Reviewer, or Drug filters, select — to include all. Note that a warning message appears if all filters are set to —, no WHERE clause exists, and no filtering by comments are specified. This is to prevent inadvertently displaying all drug-event combinations, which can have a negative performance impact. For the Drug filter, you can also specify None.
For example, consider the following drugs:
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Group |
Reviewer |
Drug |
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A |
User1 |
Acetaminophen |
|
A |
User2 |
Aspirin |
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I |
User2 |
Iron |
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N |
User1 |
Niacin |
Your group, reviewer, and drug selections have the following effect:
|
Selected group |
Selected reviewer |
Selected drug |
Combinations with any of these drugs are listed |
|
A |
User2 |
- |
Aspirin |
|
A |
- |
- |
Acetaminophen, Aspirin |
|
- |
User2 |
- |
Aspirin, Iron |
Reviewers can be assigned to drug-event combinations as well as to drugs. Thus, when you select a reviewer, you see all drug-event combinations assigned to the reviewer, in addition to any combinations that appear because of drug assignments. If you see a combination because it is assigned to you, you also see all combinations for the drug (even if the drug itself is not assigned to you).
For example, suppose that User1 is assigned to the drug Niacin, and User2 is assigned to the combination of the drug Niacin and the event Flushing. If you select User2, you see all combinations that include Niacin, even though User1 is assigned to Niacin.
The following menu options are available from the row menu, located in the left most column of the table, and affect an individual row in the table:
In this page, you can view the statistical information for each drug-event combination.
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Column |
Description |
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Drug |
Name of the drug. |
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DME |
Whether the event in the drug-event combination is a Designated Medical Event (DME). |
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Event |
Name of the Preferred Term (PT). |
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HLGT |
Name of the High Level Group Term (HLGT) that contains the PT. |
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HLT |
Name of the High Level Term (HLT) that contains the PT. |
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SOC |
Abbreviated name of the System Organ Class (SOC) containing the PT. |
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SOC Desc |
Description of the SOC that contains the PT |
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Comment |
Most recent comment, if any, entered for the drug-event combination. To review the detailed comments (if any) place the cursor over the comment. Comments can be added to a drug-event combination when you review the summary for the combination or when you filter the combination. You can also select multiple combinations and add the same comment to all of them. |
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Comment Date |
Date and time the most recent comment was added. |
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Topic Name |
If the signal management configuration has been integrated with topics, the topic name associated with the drug-event combination. If you have permission to view the topic, the name appears as a hyperlink, and when clicked, the topic appears in view mode. |
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Topic State |
If the signal management configuration has been integrated with topics, the current topic state for the topic associated with the drug-event combination. |
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Private Comment |
The most recent private comment you entered for the combination. To review the detailed comments (if any) place the cursor over the private comment. This column appears if the private comments feature is enabled in the signal configuration. |
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Private Comment Date |
Date and time the most recent private comment was added. This column appears if the private comments feature is enabled in the signal configuration. |
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Filter |
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Reviewer |
Name of the reviewer, if any, assigned to the drug-event combination. This column does not show reviewers who have been assigned to the drug. |
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N, Nsince |
The following counts may appear: N is the total count of cases (with the drug-event combination) from the earliest start date of the source data (EARLIEST_ASOFDATE value in the source description table) up through the indicated time period. Note: For combinations that include new drugs, the N column is typically empty for older time periods. Also, if drug or event term was recorded, the N column might be empty for combinations that include the previous drug or event term. The Nsince column displays the count of new or significantly changed cases (with the drug-event combination) since the indicated time period through the latest end date of the source data (ASOFDATE in the source description table). If there are no new or changed cases for a combination, the column is empty. The following table shows how N and Nsince relate to the indicated time period.
You can click the values in the N or Nsince columns to display a menu that you can use to drill-down to cases that make up the count. |
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Case score average |
For interactive signal configurations, if case scoring is implemented for the signal configuration, the average case score for the drug-event combination. The case score indicates how well populated a report is for a given drug-event combination. |
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Case score sum |
For interactive signal configurations, if case scoring is implemented for the signal configuration, the sum of case scores for the drug-event combination. |
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EBGM |
Empirical Bayesian Geometric Mean for the drug-event combination. The EBGM is a more stable estimate than RR (Relative Ratio); the so-called shrinkage estimate, computed as the geometric mean of the posterior distribution of the true Relative Ratio. For more information, see MGPS computations. |
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EB05 |
For the drug-event combination, a value such that there is approximately a 5% probability that the true Relative Ratio lies below it. The interval from EB05 to EB95 may be considered to be the 90% confidence interval. |
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EB95 |
For the drug-event combination, a value such that there is approximately a 5% probability that the true Relative Ratio lies above it. The interval from EB05 to EB95 may be considered to be the 90% confidence interval. |
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Frequency increased |
For interactive signal configurations, if increased frequency is implemented for the signal configuration, whether the drug-event combination occurred with increased frequency during the specified time period. |
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PRR_CHISQ |
Chi-square of PRR for the drug-event combination. |
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PRR |
Proportional Reporting Ratio for the drug-event combination. |
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PVALUE |
For the drug-event combination, the probability that chi-square would be as large as or larger than the value in the PRR_CHISQ column by chance alone if there were no causal relationship or consistent association between the drug and the event. Small values display in scientific notation. |
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ROR |
Reporting Odds Ratio for the drug-event combination. Without stratification, computed as: (PRR_A x PRR_D) / (PRR_B x PRR_C) With stratification, computed as a weighted average of ROR within each stratum. |
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ROR05 |
For the drug-event combination, the lower 5% confidence limit for ROR. The interval from ROR05 to ROR95 may be considered to be the 90% confidence interval. |
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ROR95 |
For the drug-event combination, the upper 5% confidence limit for ROR. The interval from ROR05 to ROR95 may be considered to be the 90% confidence interval. |
Note: Depending on how signal management is set up for your organization; a Link column may appear containing a hyperlink to a third-party application.