If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Item
If a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
If subject would not be willing to participate in a follow-up study, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
If Adverse Event or Serious Adverse Event, please specify
Item
If Adverse Event or Serious Adverse Event, please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other, please specify
Item
If other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Did the subject experience any Serious Adverse Event during the study period?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
C2347804 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
Total number of SAE's
Item
Total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study period?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study period?
CL Item
Not Applicable (not of childbearing potential or male) (N/A)
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up. (LFU)
CL Item
Other, please specify (OTH)
If Serious adverse event, please specify SAE No
Item
If Serious adverse event, please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If Non-serious adverse event, please specify AE No or solicited AE code.
Item
If Non-serious adverse event, please specify AE No or solicited AE code.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
If protocol violation, please specify
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Who made the decision?
text
C0679006 (UMLS CUI [1])
Code List
Who made the decision?
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
Please document reason for non participation
CL Item
Subject not eligible - please specify criteria that are not fulfilled (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event or other (3)
Subject not eligible - Please specify criteria that are not fulfilled
Item
Subject not eligible - Please specify criteria that are not fulfilled
text
C1555471 (UMLS CUI [1,1])
C3828770 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
integer
C3846156 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Subject eligible but not willing to participate due to adverse events, or serious adverse event, please specify
CL Item
adverse events, or serious adverse event - please specify (1)
CL Item
other - please specify (2)
If reason is adverse events or serious adverse ebents, please specify.
Item
If reason is adverse events or serious adverse ebents, please specify.
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If other Reason for Subject not willing to participate, please specify
Item
If other Reason for Subject not willing to participate, please specify
text
C0392360 (UMLS CUI [1,1])
C1136454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Subject died on
Item
Subject died on
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Local Symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
Redness/ Swelling - Size in mm (Day 0)
Item
Redness/ Swelling - Size in mm (Day 0)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 0)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 0)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Pain that prevents normal activity (3)
Redness/ Swelling - Size in mm (Day 1)
Item
Redness/ Swelling - Size in mm (Day 1)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 1)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 1)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Pain that prevents normal activity (3)
Redness/ Swelling - Size in mm (Day 2)
Item
Redness/ Swelling - Size in mm (Day 2)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 2)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 2)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Pain that prevents normal activity (3)
Redness/ Swelling - Size in mm (Day 3)
Item
Redness/ Swelling - Size in mm (Day 3)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item
Pain intensity (Day 3)
integer
C1320357 (UMLS CUI [1])
Code List
Pain intensity (Day 3)
CL Item
Painful on touch (1)
CL Item
Painful when limb is moved (2)
CL Item
Pain that prevents normal activity (3)
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptom
Item
Date of last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities.(In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy). (3)
Symptoms start date
Item
Symptoms start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptoms end date
Item
Symptoms end date
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box if symptoms are continuing
integer
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Check box if symptoms are continuing
CL Item
Symptoms continuing (1)
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End date or check box if continuing
Item
Medication End date or check box if continuing
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Item
Check box if medication continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Check box if medication continuing
CL Item
Medication continuing (1)
Item
General Symptom
integer
C0159028 (UMLS CUI [1])
Code List
General Symptom
CL Item
Gastrointestinal symptoms (4)
Item
If Temperature, record route of measurement
integer
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Code List
If Temperature, record route of measurement
Temperature
Item
Temperature
float
C0886414 (UMLS CUI [1])
Item
Fatigue intensity
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Fatigue intensity
CL Item
Fatigue that is easily tolerated (1)
CL Item
Fatigue that interferes with normal activity (2)
CL Item
Fatigue that prevents normal activity (3)
Item
Headache intensity
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Headache intensity
CL Item
Headache that is easily tolerated (1)
CL Item
Headache that interferes with normal activity (2)
CL Item
Headache that prevents normal activity (3)
Item
Gastrointestinal symptoms intensity
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Gastrointestinal symptoms intensity
CL Item
Gastrointestinal symptoms that are easily tolerated (1)
CL Item
Gastrointestinal symptoms that interfere with normal activity (2)
CL Item
Gastrointestinal symptoms that prevent normal activity (3)
Symptoms ongoing after Day 3?
Item
Symptoms ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Description - please give details below
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
Symptom intensity
Item
Symptom intensity
text
C0518690 (UMLS CUI [1])
Symptom Start date
Item
Symptom Start date
date
C1457887 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Symptoms End date or check box if continuing
Item
Symptoms End date or check box if continuing
date
C1457887 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Item
Check box if symptoms continuing
integer
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Check box if symptoms continuing
CL Item
Symptoms continuing (1)