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This is an example of an SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the sponsor to elect to use either MHENRF / or MHENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in SDTMIG Section 4.4.7, Use of Relative Timing Variables.
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Rows 1-2: | The reported events were coded using a standard dictionary. MHDECOD and MHBODSYS display the preferred term and body system assigned through the coding process. MHENRTPT was populated based on the response to the "Ongoing" question on the General Medical History CRF. MHENTPT displays the reference date for MHENRTPT, that is, the date the information was collected. If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". | Row 3: | The start and end date of the reported event was displayed. | |
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Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHTERM | MHDECOD | MHCAT | MHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT |
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1 | ABC123 | MH | 123101 | 1 | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | Respiratory system disorders | 2003 |
| ONGOING | 2004-09-18 | 2 | ABC123 | MH | 123101 | 2 | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders | 2004-07 |
| ONGOING | 2004-09-18 | 3 | ABC123 | MH | 123101 | 3 | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | Musculoskeletal system disorders | 2005-07-15 | 2005-08-31 |
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