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The table represents the items from the COMFORT-B SCALE instrument.
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| Rows 13-14: | Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX". | | Rows 15-16: | Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX". | | Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF. | |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQRSSEQ | QSTESTCDRSTESTCD | QSTESTRSTEST | QSCATRSCAT | QSORRESRSORRES | QSSTRESCRSSTRESC | QSSTRESNRSSTRESN | QSLOBXFLRSLOBXFL | VISITNUM | QSDTCRSDTC | QSEVLINTRSEVLINT |
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| 1 | STUDYX | QSRS | 2324-P0001 | 1 | IDSR101CBS0101 | IDSR1CBS01-Falling AsleepAlertness | IDSCOMFORT-SR | I never take longer than 30 minutes to fall asleep | 0 | B SCALE | lightlylightly asleep (eyes mostly closed, occasional responses) | 2 | 20 | Y | 1 | 20152023-05-15 | -P7D | | 2 | STUDYX | QSRS | 2324-P0001 | 2 | IDSR102CBS0102 | IDSR1-Sleep During the Night | IDS-SR | I do not wake up at night | 0 | CBS01-Calmness/Agitation | COMFORT-B SCALE | slightly anxious (child shows slight anxiety) | 2 | 20 | Y | 1 | 20152023-05-15 | -P7D | | 3 | STUDYX | QSRS | 2324-P0001 | 3 | IDSR103CBS0103 | IDSR1-Waking Up Too Early | IDS-SR | Most of the time, I awaken no more than 30 minutes before I need to get up | 0 | CBS01-Respiratory Response | COMFORT-B SCALE | no spontaneous respiration | 1 | 10 | Y | 1 | 20152023-05-15 | -P7D | | 4 | STUDYX | QSRS | 2324-P0001 | 4 | IDSR104CBS0104 | IDSR1CBS01-Sleeping Too MuchCrying | IDSCOMFORT-SR | I sleep no longer than 7-8 hours/night, without napping during the day | 0 | 0 | B SCALE | None |
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| Y | 1 | 20152023-05-15 | -P7D | | 5 | STUDYX | QSRS | 2324-P0001 | 5 | IDSR105CBS0105 | IDSR1CBS01-Feeling SadPhysical Movement | IDSCOMFORT-SR | I feel sad less than half the time | 1 | B SCALE | occasional, (three or fewer) slight movements | 2 | 21 | Y | 1 | 20152023-05-15 | -P7D | | 6 | STUDYX | QSRS | 2324-P0001 | 6 | IDSR106CBS0106 | IDSR1CBS01- Feeling IrritableMuscle Tone | IDSCOMFORT-SR | I feel irritable less than half the time | 1 | B SCALE | normal muscle tone | 3 | 31 | Y | 1 | 20152023-05-15 | -P7D | | 7 | STUDYX | QSRS | 2324-P0001 | 7 | IDSR107CBS0107 | IDSR1-Feeling Anxious or Tense | IDS-SR | I feel anxious (tense) less than half the time | 1 | CBS01-Facial Tension | COMFORT-B SCALE | normal facial tone | 2 | 21 | Y | 1 | 20152023-05-15 | -P7D | | 8 | STUDYX | QSRS | 2324-P0001 | 8 | IDSR108CBS0108 | IDSR1-Your Mood to Good/Desired Events | IDS-SR | My mood brightens but I do not feel like my normal self when good events occur | 1 | 1 | CBS01-Total Score | COMFORT-B SCALE | 12 | 12 | 12 | Y | 1 | 20152023-05-15 | -P7D | | 9 | STUDYX | QSRS | 2324-P0001 | 9 | IDSR109CBS0109 | IDSR1-Mood in Relation to Time of Day | IDS-SR | My mood often relates to the time of day because of environmental events (e.g., being alone, working) | 1 | CBS01-NRS Pain | COMFORT-B SCALE | 5 | 5 | 51 | Y | 1 | 20152023-05-15 | -P7D | 10 | STUDYX | QSRS | 2324-P0001 | 10 | IDSR109ACBS0110 | IDSR1-Mood Worse Morn/Afternoon/Night | IDS-SR | Afternoon | CBS01-NISS | COMFORT-B SCALE | 2 | 2 | 2Afternoon | Y | 1 | 20152023-05-15 | -P7D |
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| 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE | Midazolam |
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| 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up |
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| 1 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
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| 2 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE |
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| 3 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE |
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| 4 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
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| 5 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE |
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| 6 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE |
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| 7 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE |
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| 8 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE |
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| 9 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE |
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| 10 | CBS0110 | CBS01-NISS | COMFORT-B SCALE |
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| 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE |
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| 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
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| | Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.) |
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| | 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 | Y | 1 | 2015-05-15 |
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