Product-event combination columns

Learn about the statistical scores for product-event combinations.

If you are working with a multisource signal configuration, columns from the secondary configuration are also available. You can identify the secondary configuration columns in the list by the prefix matching the secondary configuration label defined in the multisource signal configuration.

Field descriptions—Statistical score

The columns available in the Product-Event Combinations table depend on your setup and your specific configuration.

The Product-Event Combinations columns columns dialog will contain Statistical scores for the each underlining configuration. The lead’s statistical scores will be as listed in the table. In addition there will be stat columns for each Secondary interactive signal configurations or SISM. The column names have the SISM label as a prefix. See image below, the SISM has the label VB AM.

The statistical scores that might appear for each product-event combination include the following:

Field	Description
CHISQ	Chi-square.
DRUG_NAME	Common name of product.
DRUG_TERM	Product term.
EB05	The 5 percent confidence interval for the EBGM: A value such that there is approximately a 5% probability that the true Relative Ratio lies below it. The interval from EB05 to EB95 might be considered to be the 90% confidence interval.
EB95	The 95 percent confidence interval for the EBGM: A value such that there is approximately a 5% probability that the true Relative Ratio lies above it. The interval from EB05 to EB95 might be considered to be the 90% confidence interval.
EBGM	Empirical Bayesian Geometric Mean. A more stable estimate than RR; 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.
ER05	The 5 percent confidence interval for the ERAM: A value such that there is approximately a 5% probability that the true Relative Ratio lies above it. The interval from ER05 to ER95 might be considered to be the 90% confidence interval.
ER95	The 95 percent confidence interval for the ERAM: A value such that there is approximately a 5% probability that the true Relative Ratio lies above it. The interval from ER05 to ER95 might be considered to be the 90% confidence interval.
ERAM	Empirical-Bayes Regression-adjusted Arithmetic Mean. The shrunken observed-to-expected reporting ratio adjusted for covariates and concomitant drugs. For more information, see RGPS computations.
ERAM to EBGM Ratio	Computed as ERAM / EBGM. A high ratio could be an indication that masking by other signals is suppressing non-regression-corrected scores for this PEC.
N	Observed number of cases with the combination of items.
Nsince	Number of new reports (since the date indicated in the header). If a value in this column is underlined, you can click the value to drill down to case information.
PRR	Proportional Reporting Ratio for the combination of a particular product and particular event. For more information, see PRR computations.
PRR_CHISQ	Chi-square of PRR.
PVALUE	P value for chi square statistic for PRR.
RGPS	Regression-Adjusted Gamma Poisson Shrinker. RGPS is a hybrid algorithm, which combines the methodology of Extended Logistic Regression (ELR) and MGPS. For more information, see RGPS computations.
ROR	Reporting Odds Ratio. Computed as: ROR = (PRR_A * PRR_D) / (PRR_B * PRR_C) With stratification, ROR is computed as a weighted average of the ROR within each stratum. For more information, see ROR computations.
ROR05	Lower 5% confidence limit for ROR.
ROR95	Upper 5% confidence limit for ROR. The interval from ROR05 to ROR95 might be considered to be the 90% confidence interval.
Trnd1	YES/NO flag: EB05 score for the most recent time period is at least 1.5, EBGM score based on all reports increased and current EBGM confidence interval does not overlap the EBGM confidence interval.
Trnd2	YES/NO flag: EB05 score for the most recent time period is at least 1.5, EBGM score based on all reports increased by at least 50%.

Column descriptions—Alert and review information for the product-event combination

Alert and review information for the product-event combination depend on the signal configuration setup and may include the following columns:

Column	Description
Alert	An Alert column appears for each Alert type with the Alert Flag value set as follows: YES - The alert criteria are met in the most recent refresh. P - The alert criteria are not met in the most recent refresh, but unreviewed tracked alerts exist from prior refreshes. null - The alert criteria are not met in the most recent period, and there are no unreviewed tracked alerts from previous refreshes.
Alerts	Tracked alerts triggered for each refresh. Click the alert icon to see detail information for the alert.
Comment	The most recent predefined comment added to the combination.
Comment Date	Date and time when the most recent comment was added.
Detailed Comment	The optional free text description added with the comment. This column appears only if the corresponding site option has been set.
Filter	Yes, if you added the comment when the product-event combination was suppressed. No, if you added a public comment when you were documenting your review, or when you un-suppressed the product-event combination. Empty (blank), for private comments.
Private Comment	The predefined private comment added to the combination.
Private Comment Date	Date and time when the most recent private comment was added.
Reviewer	Person assigned to review this drug-event combination.
Status	Displays two icons: An alert status icon, if a tracked alert is associated with this combination. This icon shows whether the alert has been reviewed. A topic icon, if a topic is associated with this combination. Click to view the topic.

Column descriptions—Topic information for the product-event combination

If signal management is integrated with topics, the table also includes the following columns:

Column	Description
Topic Name	Topic name and ID associated with the product-event combination.
Topic State	Current state of the topic.

Column descriptions—from MedDRA

The table may also include additional columns populated using the MedDRA dictionary associated with the data:

Column	Description
Event Term Change Description	If applicable, description of MedDRA dictionary change affecting this product-event combination.
Event Term Change Flag	Coded value indicating if a MedDRA change (previous to current version) affected this product-event combination.
HLGT	Event High Level Group Term.
HLT	Event High Level Term.
IME	Flag value set to YES if the event is a MedDRA Important Medical Event.
SOC	Abbreviated Event System Organ Class.
SOC Desc	Event System Organ Class.

Column descriptions—other columns

Other additional columns that might appear include the following:

Column	Description
DME	Flag value set to YES for designated medical events.
Event	Name of the event.
Lst	Flag value set to YES for listed drug-event combinations.
Max INTSS	Maximum interaction signal score.
Product	Name of the product.
TME	Flag value set to YES for targeted medical events.