Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSREASND | RSMETHOD | RSLOBXFL | RSREPNUM | VISITNUM | RSDTC |
---|
1 | STUDYX | RS | 2324-P0001 | 1 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
|
|
| Y | 1 | 1 | 2023-05-15 |
2 | STUDYX | RS | 2324-P0001 | 2 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE | slightly anxious (child shows slight anxiety) | 2 | 2 |
|
|
| Y | 1 | 1 | 2023-05-15 |
3 | STUDYX | RS | 2324-P0001 | 3 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE | no spontaneous respiration | 1 | 1 |
|
|
| Y | 1 | 1 | 2023-05-15 |
4 | STUDYX | RS | 2324-P0001 | 4 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
|
|
|
|
|
| Y | 1 | 1 | 2023-05-15 |
5 | STUDYX | RS | 2324-P0001 | 5 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE | occasional, (three or fewer) slight movements | 2 | 2 |
|
|
| Y | 1 | 1 | 2023-05-15 |
6 | STUDYX | RS | 2324-P0001 | 6 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE | normal muscle tone | 3 | 3 |
|
|
| Y | 1 | 1 | 2023-05-15 |
7 | STUDYX | RS | 2324-P0001 | 7 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE | normal facial tone | 2 | 2 |
|
|
| Y | 1 | 1 | 2023-05-15 |
8 | STUDYX | RS | 2324-P0001 | 8 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE | 12 | 12 | 12 |
|
|
| Y | 1 | 1 | 2023-05-15 |
9 | STUDYX | RS | 2324-P0001 | 9 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE | 5 | 5 | 5 |
|
| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 1 | 2023-05-15 |
10 | STUDYX | RS | 2324-P0001 | 10 | CBS0110 | CBS01-NISS | COMFORT-B SCALE | 2 | 2 | 2 |
|
|
| Y | 1 | 1 | 2023-05-15 |
11 | STUDYX | RS | 2324-P0001 | 11 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE | Midazolam | Midazolam |
|
|
|
| Y | 1 | 1 | 2023-05-15 |
12 | STUDYX | RS | 2324-P0001 | 12 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
|
|
|
| Y | 1 | 1 | 2023-05-15 |
13 | STUDYX | RS | 2324-P0001 | 13 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | deeply asleep (eyes closed, no response to changes in the environment) | 1 | 1 |
|
|
| Y | 2 | 1 | 2023-05-15 |
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
24 | STUDYX | RS | 2324-P0001 | 24 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
|
|
|
| Y | 2 | 1 | 2023-05-15 |
25 | STUDYX | RS | 2324-P0001 | 25 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
|
|
| Y | 3 | 1 | 2023-05-15 |
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
36 | STUDYX | RS | 2324-P0001 | 36 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
|
|
|
| Y | 3 | 1 | 2023-05-15 |
37 | STUDYX | RS | 2324-P0001 | 37 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE | lightly asleep (eyes mostly closed, occasional responses) | 2 | 2 |
|
|
| Y | 4 | 1 | 2023-05-15 |
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
48 | STUDYX | RS | 2324-P0001 | 48 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE | Post surgery follow-up | Post surgery follow-up |
|
|
|
| Y | 4 | 1 | 2023-05-15 |
49 | STUDYX | RS | 2324-P0001 | 49 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
50 | STUDYX | RS | 2324-P0001 | 50 | CBS0102 | CBS01-Calmness/Agitation | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
51 | STUDYX | RS | 2324-P0001 | 51 | CBS0103 | CBS01-Respiratory Response | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
52 | STUDYX | RS | 2324-P0001 | 52 | CBS0104 | CBS01-Crying | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
53 | STUDYX | RS | 2324-P0001 | 53 | CBS0105 | CBS01-Physical Movement | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
54 | STUDYX | RS | 2324-P0001 | 54 | CBS0106 | CBS01-Muscle Tone | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
55 | STUDYX | RS | 2324-P0001 | 55 | CBS0107 | CBS01-Facial Tension | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
56 | STUDYX | RS | 2324-P0001 | 56 | CBS0108 | CBS01-Total Score | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
57 | STUDYX | RS | 2324-P0001 | 57 | CBS0109 | CBS01-NRS Pain | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
58 | STUDYX | RS | 2324-P0001 | 58 | CBS0110 | CBS01-NISS | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
59 | STUDYX | RS | 2324-P0001 | 59 | CBS0111 | CBS01-Details Sedatives/Analgesics | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
60 | STUDYX | RS | 2324-P0001 | 60 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 1 | 2 |
|
61 | STUDYX | RS | 2324-P0001 | 61 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 2 | 2 |
|
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
72 | STUDYX | RS | 2324-P0001 | 72 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 2 | 2 |
|
73 | STUDYX | RS | 2324-P0001 | 73 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 3 | 2 |
|
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
84 | STUDYX | RS | 2324-P0001 | 84 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 3 | 2 |
|
85 | STUDYX | RS | 2324-P0001 | 85 | CBS0101 | CBS01-Alertness | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 4 | 2 |
|
... | ... | ... | 2324-P0001 | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
96 | STUDYX | RS | 2324-P0001 | 96 | CBS0112 | CBS01-Reason Assessment | COMFORT-B SCALE |
|
|
| NOT DONE |
|
|
| 4 | 2 |
|