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:
|
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 |
|
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:
|
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. |
Parent topic: Step 3: Review product-event combinations for a product