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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | VISITNUM | QSDTC | QSEVINTX | | 1 | STUDYX | QS | P0001 | 1 | EXACT101 | EXACT1-Chest Feel Congested | EXACT | Slightly | Slightly | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 2 | STUDYX | QS | P0001 | 2 | EXACT102 | EXACT1-How Often Cough | EXACT | Frequently | Frequently | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 3 | STUDYX | QS | P0001 | 3 | EXACT103 | EXACT1-Bring Up Mucus When Coughing | EXACT | A little | A little | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 4 | STUDYX | QS | P0001 | 4 | EXACT104 | EXACT1-Difficult to Bring Up Mucus | EXACT | Moderately | Moderately | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 5 | STUDYX | QS | P0001 | 5 | EXACT105 | EXACT1-Chest Discomfort | EXACT | Moderate | Moderate | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 6 | STUDYX | QS | P0001 | 6 | EXACT106 | EXACT1-Chest Feel Tight | EXACT | Slightly | Slightly | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 7 | STUDYX | QS | P0001 | 7 | EXACT107 | EXACT1-Breathless | EXACT | Slightly | Slightly | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 8 | STUDYX | QS | P0001 | 8 | EXACT108 | EXACT1-Describe How Breathless | EXACT | Breathless during light activity | Breathless during light activity | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 9 | STUDYX | QS | P0001 | 9 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT | Severely | Severely | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 10 | STUDYX | QS | P0001 | 10 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT | Moderately | Moderately | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 11 | STUDYX | QS | P0001 | 11 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT | Extremely | Extremely | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 12 | STUDYX | QS | P0001 | 12 | EXACT112 | EXACT1-Tired or Weak | EXACT | Slightly | Slightly | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 13 | STUDYX | QS | P0001 | 13 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT | Not at all | Not at all | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 14 | STUDYX | QS | P0001 | 14 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT | Slightly | Slightly | | | | | 2012-11-16 | EVERY EVENING BEFORE BEDTIME | | 15 | STUDYX | QS | P0001 | 15 | EXACT101 | EXACT1-Chest Feel Congested | EXACT | Slightly | Slightly | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 16 | STUDYX | QS | P0001 | 16 | EXACT102 | EXACT1-How Often Cough | EXACT | Frequently | Frequently | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 17 | STUDYX | QS | P0001 | 17 | EXACT103 | EXACT1-Bring Up Mucus When Coughing | EXACT | A little | A little | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 18 | STUDYX | QS | P0001 | 18 | EXACT104 | EXACT1-Difficult to Bring Up Mucus | EXACT | Moderately | Moderately | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 19 | STUDYX | QS | P0001 | 19 | EXACT105 | EXACT1-Chest Discomfort | EXACT | Moderate | Moderate | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 20 | STUDYX | QS | P0001 | 20 | EXACT106 | EXACT1-Chest Feel Tight | EXACT | Slightly | Slightly | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 21 | STUDYX | QS | P0001 | 21 | EXACT107 | EXACT1-Breathless | EXACT | Slightly | Slightly | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 22 | STUDYX | QS | P0001 | 22 | EXACT108 | EXACT1-Describe How Breathless | EXACT | Breathless during light activity | Breathless during light activity | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 23 | STUDYX | QS | P0001 | 23 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT | Severely | Severely | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 24 | STUDYX | QS | P0001 | 24 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT | Moderately | Moderately | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 25 | STUDYX | QS | P0001 | 25 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT | Extremely | Extremely | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 26 | STUDYX | QS | P0001 | 26 | EXACT112 | EXACT1-Tired or Weak | EXACT | Slightly | Slightly | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 27 | STUDYX | QS | P0001 | 27 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT | Not at all | Not at all | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME | | 28 | STUDYX | QS | P0001 | 28 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT | Slightly | Slightly | | NOT DONE | NO RESPONSE COLLECTED | | 2012-11-17 | EVERY EVENING BEFORE BEDTIME |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
...
QSTESTCD = "EXACT114" QSTEST = "EXACT1-Worried About Lung Problems"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Severely | Severely |
|
| Extremely | Extremely |
|
QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Rarely | Rarely |
|
| Occasionally | Occasionally |
|
| Frequently | Frequently |
|
| Almost constantly | Almost constantly |
|
QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| None at all | None at all |
|
| A little | A little |
|
| Some | Some |
|
| A great deal | A great deal |
|
| A very great deal | A very great deal |
|
QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Quite a bit | Quite a bit |
|
| Extremely | Extremely |
|
QSTESTCD = "EXACT105" QSTEST = "EXACT1-Chest Discomfort"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slight | Slight |
|
| Moderate | Moderate |
|
| Severe | Severe |
|
| Extreme | Extreme |
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QSTESTCD = "EXACT108" QSTEST = "EXACT1-Describe How Breathless"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Unaware of breathlessness | Unaware of breathlessness |
|
| Breathless during strenuous activity | Breathless during strenuous activity |
|
| Breathless during light activity | Breathless during light activity |
|
| Breathless when washing or dressing | Breathless when washing or dressing |
|
| Present when resting | Present when resting |
|
QSTESTCD = "EXACT109" QSTEST = "EXACT1-Short Breath Personal Care"
...
QSTESTCD = "EXACT111" QSTEST = "EXACT1-Short Breath Outside Activities"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Severely | Severely |
|
| Extremely | Extremely |
|
| Too breathless to do these | Too breathless to do these |
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End of Document