| # | Question | Response |
|---|---|---|
|
1
|
Adverse Event Verbatim
field_001
|
|
|
2
|
Event Category
field_002
|
|
|
3
|
Did the event start before administering first dose of study medication?
field_003
|
|
|
4
|
Date Started
field_004
|
|
|
5
|
Event ongoing?
field_005
|
|
|
6
|
Date Ended
field_006
|
|
|
7
|
Severity of the Event
field_007
|
|
|
8
|
Event Related to Study Drug
field_008
|
|
|
9
|
Toxicity Grade of the Event (CTCAE)
field_009
|
|
|
10
|
Action Taken with Study Drug because of Adverse Event
field_010
|
|
|
11
|
Other action taken?
field_011
|
|
|
12
|
Serious Event?
field_012
|
|
|
13
|
Resulted in Death?
field_013
|
|
|
14
|
Immediately Life Threatening?
field_014
|
|
|
15
|
Required Hospitalization or Prolonged Hospitalization?
field_015
|
|
|
16
|
If hospitalized,Â
field_016
|
|
|
17
|
date of hospitalization
field_017
|
|
|
18
|
Time of hospitalization
field_018
|
|
|
19
|
If hospitalized,Â
field_019
|
|
|
20
|
date of discharge
field_020
|
|
|
21
|
Time of discharge
field_021
|
|
|
22
|
Persistent or Significant Disability?
field_022
|
|
|
23
|
Congenital Anomaly/Birth Defect?
field_023
|
|
|
24
|
Other Medically Important Serious Event?
field_024
|
|
|
25
|
Outcome of the Event?
field_025
|
|
|
26
|
Was the event adjudicated
field_026
|
|
|
27
|
Adjudication Result
field_027
|
|
|
28
|
Relationship to Non-Study Treatment
field_028
|
| # | Question | Response |
|---|---|---|
|
1
|
Did the patient fall since last visit?
field_001
|
|
|
2
|
Date of fall
field_002
|
|
|
3
|
Time of the day
field_003
|
|
|
4
|
Environment (of fall)
field_004
|
|
|
5
|
Activity at the time of fall
field_005
|
|
|
6
|
Fall Mechanism
field_006
|
|
|
7
|
Did the fall result in injury
field_007
|
|
|
8
|
Severity of the injury
field_008
|
|
|
9
|
field_009
|
| # | Question | Response |
|---|---|---|
|
1
|
Did subject have any hypoglycemic events since the last visit?
field_001
|
|
|
2
|
Sequence Identifier
field_002
|
|
|
3
|
Hypoglycemic event start date
field_003
|
|
|
4
|
Hypoglycemic event start time
field_004
|
|
|
5
|
What was the date of last study treatment before the event?
field_005
|
|
|
6
|
What was the time of last study treatment before the event?
field_006
|
|
|
7
|
What was the subject's awareness of the hypoglycemic event?
field_007
|
|
|
8
|
Blood glucose concentration measured prior to treating the event?
field_008
|
|
|
9
|
If measured, what is the blood glucose concentration
field_009
|
|
|
10
|
Unit of blood glucose concentration measurement
field_010
|
|
|
11
|
Were signs/symptoms of hypoglycemia present, other than the blood glucose reading?
field_011
|
|
|
12
|
What was the hypoglycemic event outcome?
field_012
|
|
|
13
|
Specify if outcome is other
field_013
|
|
|
14
|
Was treatment given because of the occurrence of the event?
field_014
|
|
|
15
|
If yes, how was the hypoglycemic event treatment
field_015
|
|
|
16
|
field_016
|
| # | Question | Response |
|---|---|---|
|
1
|
Adverse Event Identifier
field_001
|
|
|
2
|
Has the subject recently received a blood transfusion or traveled to an
field_002
|
|
|
3
|
Does the subject have signs or symptoms consistent with Hepatitis?
field_003
|
|
|
4
|
Has the subject recently experienced occupational or toxic exposure?
field_004
|
|
|
5
|
Has the subject had a recent increase in alcohol use?
field_005
|
|
|
6
|
Has the subject had a recent increase in recreational drug use?
field_006
|
|
|
7
|
Have any local labs been performed that pertain to this event?
field_007
|
|
|
8
|
Indicate the most severe Hepatobiliary AESI experienced by the Subject.
field_008
|
|
|
9
|
Has there been a serological evaluation for viral hepatitis A, B, or C,
field_009
|
|
|
10
|
Has a gastrointestinal or hepatobiliary consult occurred?
field_010
|
|
|
11
|
Did the patient have any other additional required procedures?
field_011
|
|
|
12
|
If yes, Specify the other additional required procedures
field_012
|
|
|
13
|
field_013
|
| # | Question | Response |
|---|---|---|
|
1
|
Date of assessment
field_001
|
|
|
2
|
Did the subject have any injection site reacion events?
field_002
|
|
|
3
|
What is the date of the injection?
field_003
|
|
|
4
|
What date did the injection site reaction start?
field_004
|
|
|
5
|
At what time did the injection site reaction start?
field_005
|
|
|
6
|
What date did the injection site reaction end?
field_006
|
|
|
7
|
At what time did the injection site reaction end?
field_007
|
|
|
8
|
Was there pain (including burning) at the injection site?
field_008
|
|
|
9
|
Was there itching at the injection site?
field_009
|
|
|
10
|
Was there a rash (or redness) at the injection site?
field_010
|
|
|
12
|
Was there an open sore at the injection site?
field_012
|
|
|
14
|
What was the anatomical location of the injection site reaction?
field_014
|
|
|
15
|
field_015
|
| # | Question | Response |
|---|---|---|
|
1
|
Medical Condition
field_001
|
|
|
2
|
Date of diagnosis
field_002
|
|
|
3
|
Stage of Chronic Kidney Disease
field_003
|
|
|
4
|
What is the likely etiology of CKD?
field_004
|
|
|
5
|
field_005
|