Product Impact on Individual Health only:
Interventions (e.g., concomitant medications) and events (e.g., medical history) can be collected as responses to a prespecified list of treatments or terms. In such cases:
- --PRESP represents when topic variable values, specific interventions (--TRT), or events (–TERM) were prespecified at the time of data collection. Values will be "Y" (for "Yes") or a null value.
- --OCCUR represents whether prespecified interventions or events occurred or did not occur. Values will be populated for prespecified interventions and events only populated will be . Possible values are "Y" and "N" (for "Yes" and "No").
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-629 |
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When an intervention or event is not prespecified, the value of --OCCUR will be null. - --STAT and --REASND can be used to provide information about prespecified interventions and events for which there is no response (e.g., investigator forgot to ask). In such cases the value of --STAT will be "NOT DONE" and the value of --REASND will be the reason when collected.
The following table shows the population of --PRESP, --OCCUR, --STAT, and --REASND for different data collection scenarios.
| Collection Scenario | --PRESP Value | --OCCUR Value | --STAT Value | --REASND Value |
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| An intervention or event was prespecified at the time of collection and occurred. | Y | Y |
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| An intervention or event was prespecified at the time of collection and did not occur. | Y | N |
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| An intervention or event was prespecified at the time of collection with no response and no reason collected. | Y |
| NOT DONE |
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| An intervention or event was prespecified at the time of collection with no response and reason collected. | Y |
| NOT DONE | Forgot to ask. |
| A spontaneously reported intervention or event was collected. |
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