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Forms in FA (7)

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Adverse Events

Sources: DB1 | Forms loaded: 7

AE (Adverse Events)

FA (Findings About Events or Interventions)

HO (Healthcare Encounters)

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AE, FA, HO

#	Question	Response / annotation
1	Adverse Event Verbatim field_001	AETERM FAOBJ
2	Event Category field_002	General Adverse Event Event of Interest AECAT
3	Did the event start before administering first dose of study medication? field_003	Yes No PRFDOS in SUPPAE
4	Date Started field_004	AESTDTC
5	Event ongoing? field_005	No Yes AEENRTPT
6	Date Ended field_006	AEENDTC
7	Severity of the Event field_007	Mild Moderate Severe AESEV
8	Event Related to Study Drug field_008	Yes No AEREL
9	Toxicity Grade of the Event (CTCAE) field_009	1 2 3 4 5 AETOXGR
10	Action Taken with Study Drug because of Adverse Event field_010	No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn AEACN
11	Other action taken? field_011	AEACNOTH
12	Serious Event? field_012	Yes No AESER
13	Resulted in Death? field_013	Yes No AESDTH
14	Immediately Life Threatening? field_014	Yes No AESLIFE
15	Required Hospitalization or Prolonged Hospitalization? field_015	Yes No AESHOSP
16	Hospital admission details field_016
17	Date of hospitalization field_017	HOSTDTC
18	Time of hospitalization field_018	HOSTDTC
19	Hospital discharge details field_019
20	Date of discharge field_020	HOENDTC
21	Time of discharge field_021	HOENDTC
22	Persistent or Significant Disability? field_022	Yes No AESDISAB
23	Congenital Anomaly/Birth Defect? field_023	Yes No AESCONG
24	Other Medically Important Serious Event? field_024	Yes No AESMIE
25	Outcome of the Event? field_025	Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown AEOUT
26	Was the event adjudicated? field_026	Yes No FAORRES when FATESTCD = ADJUD
27	Adjudication Result field_027	Positive Negative FAORRES when FATESTCD = ADJRES
28	Relationship to Non-Study Treatment field_028	Adjunct Therapy Study Disease Other Medical Condition Study Procedure None AERELNST

Falls

Sources: DB1 | Forms loaded: 7

CE (Clinical Events)

FA (Findings About Events or Interventions)

CEPRESP = Y

CETERM = FALL

FAOBJ = FALL

FACAT = FALL

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CE, FA

#	Question	Response / annotation
1	Did the patient fall since last visit? field_001	No Yes Unknown CEOCCUR when CETERM = FALL
2	Date of fall field_002	CESTDTC
3	Time of the day field_003	MORNING AFTERNOON EVENING NIGHT UNKNOWN FAORRES when FATESTCD = FALL1
4	Environment (of fall) field_004	AT HOME: INSIDE AT HOME: OUTSIDE AWAY FROM HOME: FAMILIAR PLACE AWAY FROM HOME: STRANGE PLACE UNKNOWN FAORRES when FATESTCD = FALL2
5	Activity at the time of fall field_005	WALKING CHANGING POSITION STAIRS PHYSICAL ACTIVITY OTHER FAORRES when FATESTCD = FALL3
6	Fall Mechanism field_006	TRIPPING SLIPPING STAIR FALL FALL FROM AN UPPER LEVEL OTHER EXTRINSIC MECHANISM INTRINSIC MECHANISM FAORRES when FATESTCD = FALL4
7	Did the fall result in injury field_007	No Yes FAORRES when FATESTCD = FALL5
8	Severity of the injury field_008	MINOR INJURY NOT REQUIRING MEDICAL ATTENTION MODERATE INJURY REQUIRING MEDICAL ATTENTION SEVERE INJURY REQUIRING EMERGENCY OR INPATIENT THERAPY FAORRES when FATESTCD = FALL6

Ce Hypoglyc

Sources: DB1 | Forms loaded: 7

CE (Clinical Events)

FA (Findings About Events or Interventions)

CEPRESP = Y

CETERM = HYPOGLYCEMIC EVENT

FAOBJ = HYPOGLYCEMIC EVENT

FAEVAL = INVESTIGATOR

FACAT = HYPOGLYCEMIC EVENTS

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CE, FA

#	Question	Response / annotation
1	Did subject have any hypoglycemic events since the last visit? field_001	No Yes CEOCCUR when CETERM = HYPOGLYCEMIC EVENT
2	Sequence Identifier field_002	CESPID
3	Hypoglycemic event start date field_003	CESTDTC
4	Hypoglycemic event start time field_004	CESTDTC
5	What was the date of last study treatment before the event? field_005	FAORRES when FATESTCD = LDOSDTC
6	What was the time of last study treatment before the event? field_006	FAORRES when FATESTCD = LDOSDTC
7	What was the subject's awareness of the hypoglycemic event? field_007	Self-aware Dependent on another Unaware FAORRES when FATESTCD = HYPOR1
8	Blood glucose concentration measured prior to treating the event? field_008	No Yes FAORRES when FATESTCD = HYPOR2
9	If measured, what is the blood glucose concentration field_009	FAORRES when FATESTCD = HYPOR3
10	Unit of blood glucose concentration measurement field_010	Milligram per deciliter Millimole per liter FAORRESU when FATESTCD = HYPOR3
11	Were signs/symptoms of hypoglycemia present, other than the blood glucose reading? field_011	No Yes Unknown FAORRES when FATESTCD = HYPOR4
12	What was the hypoglycemic event outcome? field_012	Coma Promptly recovered Automobile accident Prolonged recovery Seizure Loss of consciousness Other FAORRES when FATESTCD = HYPOR5
13	Specify if outcome is other field_013	FAORRES when FATESTCD = HYPOR5S
14	Was treatment given because of the occurrence of the event? field_014	No Yes FAORRES when FATESTCD = HYPOR6
15	If yes, how was the hypoglycemic event treated? field_015	Food Drink Glucose tablets Glucagon injection Intravenous glucose FAORRES when FATEST = Treatment of Hypoglycemic Event

Hepatobiliary assessment form

Sources: DB1 | Forms loaded: 7

FA (Findings About Events or Interventions)

FACAT = HEPATOBILIARY EVENT QUESTIONNAIRE

FAOBJ identifies the associated adverse event

FAEVAL = INVESTIGATOR

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#	Question	Response / annotation
1	Adverse Event Identifier field_001	FAGRPID RELREC when FAGRPID = AEGRPID
2	Has the subject recently received a blood transfusion or traveled to an area with Endemic Hepatitis or other infectious disease? field_002	No Yes Unknown FAORRES when FATESTCD = HEPAR1
3	Does the subject have signs or symptoms consistent with Hepatitis? field_003	No Yes Unknown FAORRES when FATESTCD = HEPAR2
4	Has the subject recently experienced occupational or toxic exposure? field_004	No Yes Unknown FAORRES when FATESTCD = HEPAR3
5	Has the subject had a recent increase in alcohol use? field_005	No Yes Unknown FAORRES when FATESTCD = HEPAR4
6	Has the subject had a recent increase in recreational drug use? field_006	No Yes Unknown FAORRES when FATESTCD = HEPAR5
7	Have any local labs been performed that pertain to this event? field_007	No Yes Unknown FAORRES when FATESTCD = HEPAR6
8	Indicate the most severe Hepatobiliary AESI experienced by the Subject. field_008	Elevation in ALT >= 3X and <5X ULN and the total bilirubin is <2X ULN ALT or AST >=3X ULN and total bilirubin >=2X ULN Total bilirubin >= 3.0 mg/dl (regardless of ALT values) ALT or AST >= 5X ULN Total bilirubin >= 2X ULN and <3.0 mg/dl with no jaundice and ALT, AST < ULN FAORRES when FATESTCD = HEPAR7
9	Has there been a serological evaluation for viral hepatitis A, B, or C, and Anti-Nuclear Antibodies (ANA), Anti-Smooth Muscle Antibody (ASMA), and Prothrombin Time, (International normalize ratio [INR])? field_009	No Yes Unknown FAORRES when FATESTCD = HEPAR8
10	Has a gastrointestinal or hepatobiliary consult occurred? field_010	No Yes Unknown FAORRES when FATESTCD = HEPAR9
11	Did the patient have any other additional required procedures? field_011	No Yes Unknown FAORRES when FATESTCD = HEPAR10
12	If yes, Specify the other additional required procedures field_012	FAORRES when FATESTCD = HEPAR10S

Injection Site Reaction

Sources: DB1 | Forms loaded: 7

CE (Clinical Events)

FA (Findings About Events or Interventions)

CEPRESP = Y

CETERM = INJECTION SITE REACTION

FACAT = INJECTION SITE REACTION

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CE, FA

#	Question	Response / annotation
1	Date of assessment field_001	FADTC
2	Did the subject have any injection site reaction events? field_002	Yes No CEOCCUR when CETERM = INJECTION SITE REACTION
3	What is the date of the injection? field_003	INJDTC in SUPPCE
4	What date did the injection site reaction start? field_004	CESTDTC
5	At what time did the injection site reaction start? field_005	CESTDTC
6	What date did the injection site reaction end? field_006	CEENDTC
7	At what time did the injection site reaction end? field_007	CEENDTC
8	Was there pain (including burning) at the injection site? field_008	None Mild Moderate Severe FAORRES when FATESTCD = SEV and FAOBJ = INJECTION SITE PAIN
9	Was there itching at the injection site? field_009	None Mild - lasted for less than one minute Moderate - lasted for more than one minute but less than one hour Severe - constant FAORRES when FATESTCD = SEV and FAOBJ = INJECTION SITE ITCHING
10	Was there a rash (or redness) at the injection site? field_010	None Mild - less than or equal to 1 cm Moderate - greater than 1 cm Severe - greater than 1 cm and raised FAORRES when FATESTCD = SEV and FAOBJ = INJECTION SITE RASH
12	Was there an open sore at the injection site? field_012	No Yes FAORRES when FATESTCD = OCCUR and FAOBJ = INJECTION SITE OPEN SORE
14	What was the anatomical location of the injection site reaction? field_014	Abdomen Arm Buttock Thigh CELOC

Anemia History

Sources: DB1 | Forms loaded: 7

MH (Medical History)

FA (Findings About Events or Interventions)

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MH, FA

#	Question	Response / annotation
1	Medical Condition field_001	MHTERM
2	Date of diagnosis field_002	MHSTDTC
3	Did the patient have any symptoms of Anemia in the past? (if yes, tick all that apply) field_003	No Yes [NOT SUBMITTED]
4	Shortness of breath field_004	Yes FAORRES when FATESTCD = OCCUR and FAOBJ = SHORTNESS OF BREATH FACAT = ANEMIA HISTORY
5	Fatigue field_005	Yes FAORRES when FATESTCD = OCCUR and FAOBJ = FATIGUE
6	Other symptoms field_006	Yes FAORRES when FATESTCD = OCCUR and FAOBJ = OTHER SYMPTOM
7	If 'Other', specify field_007	FAOBJ

Chronic Kidney Diseaase History

Sources: DB1 | Forms loaded: 7

MH (Medical History)

FA (Findings About Events or Interventions)

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MH, FA

#	Question	Response / annotation
1	Medical Condition field_001	MHTERM = CHRONIC KIDNEY DISEASE
2	Date of diagnosis field_002	MHSTDTC
3	Stage of Chronic Kidney Disease field_003	STAGE 3 STAGE 4 STAGE 5 FAORRES when FATESTCD = STAGE
4	What is the likely etiology of CKD? field_004	DIABETIC NEPHROPATHY HYPERTENSIVE NEPHROPATHY IDIOPATHIC NEPHROPATHY FAORRES when FATESTCD = CKDET