Concomitant Medication Sequence Number
Item
Concomitant Medication Sequence Number
text
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Concomitant Medication - Drug Name
Item
Concomitant Medication - Drug Name
text
C2347852 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Concomitant Medication - Total daily dose
Item
Concomitant Medication - Total daily dose
float
C2347852 (UMLS CUI [1])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Concomitant Medication - Unit
Item
Concomitant Medication - Unit
text
C2347852 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Concomitant Medication - Indication
Item
Concomitant Medication - Indication
text
C2826696 (UMLS CUI [1])
Item
Concomitant Medication - Start date - Complete Date Unknown
integer
C2826734 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Concomitant Medication - Start date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - Start date/ time
Item
Concomitant Medication - Start date/ time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Concomitant Medication - Taken prior to sudy?
Item
Concomitant Medication - Taken prior to sudy?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medication - Ongoing?
Item
Concomitant Medication - Ongoing?
boolean
C2826666 (UMLS CUI [1])
Item
Concomitant Medication - End date - Complete Date unknown
integer
C2826744 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Concomitant Medication - End date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Concomitant Medication - End date/ time
Item
Concomitant Medication - End date/ time
datetime
C2826744 (UMLS CUI [1])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
AE/ SAE related?
Item
AE/ SAE related?
boolean
C1518404 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0869014 (UMLS CUI [2,2])
Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
Item
Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
boolean
C1514463 (UMLS CUI [1,1])
C0033082 (UMLS CUI [1,2])
C2827774 (UMLS CUI [2,1])
C0033082 (UMLS CUI [2,2])
Non-Drug Sequence Number
Item
Non-Drug Sequence Number
integer
C0033082 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Non-Drug Therapy Name
Item
Non-Drug Therapy Name
text
C0033082 (UMLS CUI [1,1])
C2826274 (UMLS CUI [1,2])
Non-Drug Indication
Item
Non-Drug Indication
text
C0033082 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Item
Non-Drug Therapy - Start Date - Complete Date unknown
integer
C0033082 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Code List
Non-Drug Therapy - Start Date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Non-Drug Therapy - Start Date
Item
Non-Drug Therapy - Start Date
date
C0033082 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Non-Drug Therapy - Taken prior to study?
Item
Non-Drug Therapy - Taken prior to study?
boolean
C0033082 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Non-Drug Therapy ongoing?
Item
Non-Drug Therapy ongoing?
boolean
C0033082 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
Non-Drug Therapy - End Date - Complete Date unknown
integer
C0033082 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
Code List
Non-Drug Therapy - End Date - Complete Date unknown
CL Item
Complete Date Unknown (1)
Non-Drug Therapy - End Date/Time
Item
Non-Drug Therapy - End Date/Time
datetime
C0033082 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
C0033082 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Non-Drug Therapy - AE/ SAE related?
Item
Non-Drug Therapy - AE/ SAE related?
boolean
C0033082 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0033082 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Did a female partner of a male subject become pregnant during the study?
Item
Did a female partner of a male subject become pregnant during the study?
boolean
C0919624 (UMLS CUI [1])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Date of event
Item
Date of event
date
C0441471 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Time of day
integer
C0040223 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
CL Item
Early evening (3)
Item
1. What were you doing at the time of this event?
integer
C2828361 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Code List
1. What were you doing at the time of this event?
CL Item
Passenger in car (3)
If you were doing something different, specify
Item
If you were doing something different, specify
text
C2828361 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
2. Prior to this event, did you experience any sleepiness or drowsiness?
Item
2. Prior to this event, did you experience any sleepiness or drowsiness?
boolean
C0441471 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C2830004 (UMLS CUI [2])
C0013144 (UMLS CUI [3])
2A. If yes, please explain/clarify:
Item
2A. If yes, please explain/clarify:
text
C2830004 (UMLS CUI [1])
C0013144 (UMLS CUI [2])
C0681841 (UMLS CUI [3])
3. What specifically happened?
Item
3. What specifically happened?
text
C2348235 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
4. How long did this event last?
Item
4. How long did this event last?
integer
C0441471 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Event duration unit
integer
C0441471 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Code List
Event duration unit
5. Did you suffer any
Item
5. Did you suffer any "bad" outcome/problem from this falling asleep event?
boolean
C1624730 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Please explain/clarify
Item
Please explain/clarify "bad" outcome/problem
text
C1624730 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])