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Device related physical activity and stress

Sources: DB1 | Forms loaded: 5

CE (Clinical Events)

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#	Question	Response / annotation
1	Did the subject experience any unusual physical activity or stress because of wearing the device? field_001	Yes [NOT SUBMITTED]
2	Did the subject experience any unusual physical activity or stress because of wearing the device? field_002	No [NOT SUBMITTED]
3	Did the subject experience unusual physical activity? field_003	Yes No CEOCCUR when CETERM = PHYSICAL ACTIVITY
4	Start date of unusual physical activity field_004	CESTDTC when CETERM = PHYSICAL ACTIVITY
5	Start time of unusual physical activity field_005	CESTDTC when CETERM = PHYSICAL ACTIVITY
6	Stop date of unusual physical activity field_006	CEENDTC when CETERM = PHYSICAL ACTIVITY
7	Stop time of unusual physical activity field_007	CEENDTC when CETERM = PHYSICAL ACTIVITY
8	Did the subject experience a stressful event? field_008	Yes No CEOCCUR when CETERM = STRESS
9	Start date of stressful event field_009	CESTDTC when CETERM = STRESS
10	Start time of stressful event field_010	CESTDTC when CETERM = STRESS
11	Stop date of stressful event field_011	CEENDTC when CETERM = STRESS
12	Stop time of stressful event field_012	CEENDTC when CETERM = STRESS

Falls

Sources: DB1 | Forms loaded: 5

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: 5

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

Injection Site Reaction

Sources: DB1 | Forms loaded: 5

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

Investigator Tumor Response Assessment

Sources: DB1 | Forms loaded: 5

RS (Disease Response and Clin Classification)

CE (Clinical Events)

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RS, CE

#	Question	Response / annotation
1	Was the Investigator's assessment of overall response obtained? field_001	Yes No [NOT SUBMITTED]
2	Investigator's assessment of overall response field_002	Complete Remission (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) RSORRES when RSTESTCD = OVRLRESP
3	Response Assessment Date field_003	RSDTC when RSTESTCD = OVRLRESP
4	Reason the Investigator's assessment of overall response was not obtained field_004	Not Evaluable (NE) RSORRES = NE when RSTESTCD = OVRLRESP No Assessment Performed RSSTAT = NOT DONE when RSTESTCD = OVRLRESP RSORRES / RSSTAT when RSTESTCD = OVRLRESP
5	Did the patient experience symptomatic deterioration? field_005	Yes No CEOCCUR when CETERM = SYMPTOMATIC DETERIORATION CEPRESP = Y
6	Date of Symptomatic Deterioration field_006	CESTDTC when CETERM = SYMPTOMATIC DETERIORATION