| Order | Question Text | Prompt | CRF Completion Instructions | Type | CDASH Variable | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value | 1 | Were there any adverse experiences? | Any Adverse Experiences | Indicate if the subject experienced any adverse experiences . If Yes, include the appropriate details where indicated on the CRF. | Text | AEYN | N/A | (NY) | Yes; No | 2 | What is the category of the adverse experience? | Adverse Experiences
Category | Record the adverse experience category, if not pre-printed on the CRF. | Text | AECAT | AECAT | Applicant Defined | 3 | What is the subcategory of the adverse experience? | Adverse Experience Subcategory | Record the adverse experience subcategory, if not pre-printed on the CRF. | Text | AESCAT | AESCAT | Applicant Defined | 4 | What is the adverse experience identifier? | AE Number | If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier. | Integer | AESPID | AESPID | 5 | What is the adverse experience term? | Adverse Experiences | Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom. | Text | AETERM | AETERM | 6 | What is the adverse experience start date? | Start Date | Record the start date of the AE using this format (DD-MON-YYYY). | Date | AESTDAT | AESTDTC | 7 | Is the adverse experience ongoing? | Ongoing | Indicate if the adverse experience has not resolved at the time of data collection; leave the End Date blank. | Text | AEONGO | AEENRTPT; AEENRF | AEENRTPT/ AEENRF | (NY) | Yes | 8 | What was the adverse experience end date? | End Date | Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank. | date | AEENDAT | AEENDTC | 9 | What is the severity of the adverse experience? | Severity | The reporting physician/healthcare professional will assess the severity of the experience using applicant-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type experiences observed in clinical practice. Severity is not equivalent to seriousness. | Text | AESEV | AESEV | (AESEV) | MILD; MODERATE; SEVERE | 10 | Was the adverse experience serious? | Serious | Assess if an adverse experience should be classified as serious based on the criteria defined in the protocol. | Text | AESER | AESER | (NY) | Yes; No | 11 | Did the adverse experience result in death? | Death | Record whether the serious adverse experience resulted in death. | Text | AESDTH | AESDTH | (NY) | Yes; No | 12 | What[was the subject’s date of death? | Death Date | Record the date of death. | date | DTHDAT | DM.DTHDTC | 13 | Was the adverse experience life-threatening? | Life Threatening | Record whether the serious adverse experience is life-threatening. | Text | AESLIFE | AESLIFE | (NY) | Yes; No | 14 | Did the adverse experience result in initial or prolonged hospitalization for the subject? | Hospitalization (initial or prolonged) | Record whether the serious adverse experience resulted in an initial or prolonged hospitalization. | Text | AESHOSP | AESHOSP | (NY) | Yes; No | 15 | Did the adverse experience result in disability or permanent damage? | Disability or Permanent Damage | Record whether the serious adverse experience resulted in a persistent or significant disability or incapacity. | Text | AESDISAB | AESDISAB | (NY) | Yes; No | 16 | Was the adverse experience associated with a congenital anomaly or birth defect? | Congenital Anomaly or Birth Defect | Record whether the serious adverse experience was associated with congenital anomaly or birth defect. | Text | AESCONG | AESCONG | (NY) | Yes; No | 17 | Did the adverse experience require intervention to prevent permanent impairment or damage resulting from the use of a medical product? | Needs Intervention to Prevent Impairment | Record whether the serious adverse experience required intervention to prevent permanent impairment or damage due to the use of a medical product. | Text | AESINTV | SUPPAE.QVAL | (NY) | Yes; No | 18 | Was the adverse experience a medically important event not covered by other "serious" criteria? | Other Serious (Important Medical Events) | Record whether the serious adverse experience is an important medical event, which may be defined in the protocol or in the investigator brochure. | Text | AESMIE | AESMIE | (NY) | Yes; No | 19 | Was this adverse experience related to study product? | Relationship to Study Product | Indicate if the cause of the adverse experience was related to the study product and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). | Text | AEREL | AEREL | NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED | 20 | What action was taken with the study product? | Action Taken with Study Product | Record changes made to the study intervention resulting from the adverse experience. | Text | AEACN | AEACN | (ACN) | DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE | 21 | What is the outcome of this adverse experience? | Outcome | Record the appropriate outcome of the experience in relation to the subject's status. | Text | AEOUT | AEOUT | (OUT) | RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL | 22 | What is the action taken with a device? | Action Taken with Device | Record any action taken with a device as the result of the adverse experience. The device may or may not be a device under study. | Text | AEACNDEV | AEACNDEV | (DEACNDEV) | CALIBRATION;REMOVAL; REPROGRAMMING
23 | Was this adverse experience related to a device? | Relationship of Experience to Device | Record the relationship of the adverse experience to Device | Text | AERLDEV | AERLDEV | NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED |
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