Page History

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Dataset wrap

Name	adapch

Dataset2

Row

STUDYID

USUBJID

SITEID

QSSEQ

RSSEQ

ASEQ

ITTFL

TRTP

PARAM

PARAMCD

PARAMN

PARCAT1

VISIT

VISITNUM

AVISIT

AVISITN

QSDTC

RSDTC

ADT

ADY

QSORRES

RSORRES

AVAL

RSORRESU

AVALCAT1

RSLOBXFL

BASE

RSCBRFL

CHG

AVAL

DTYPE

ABLFL

COUNTRY

ANL01FL

REGION1

INVNAM

REGION1N
1	STUDYX	X-

101

100-P0001

101

100

1

Y

DRUG A + SOC

GDS02-Satisfied With Life

APCH1-Temperature - Rectal

APCH101

GDS0201

1

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

0

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	38.5-38.9	C	Y		1		Y	USA	North America	1
2	STUDYX	X-

101

100-P0001

101

100

2

Y

DRUG A + SOC

GDS02-Dropped Activities and Interests

APCH1-Mean Arterial Pressure

APCH102

GDS0202

2

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

	2014-06-24	24JUN2014	-5	110-129	mmHg	Y		2		Y	USA	North America	1
3	STUDYX	X-

101

100-P0001

101

100

3

Y

DRUG A + SOC

GDS02-Life Is Empty

APCH1-Heart Rate

APCH103

GDS0203

3

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

NO

0

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	70-109	beats/min	Y		0		Y	USA	North America	1
4	STUDYX	X-

101

100-P0001

101

100

4

Y

DRUG A + SOC

GDS02

APCH1-

Bored Often

Respiratory Rate

GDS0204

APCH104

4

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	25-34	breaths/min	Y		1		Y	USA	North America	1
5	STUDYX	X-

101

100-P0001

101

100

5

Y

DRUG A

GDS02-Good Spirits Most of Time

+ SOC

APCH1-Oxygenation: A-aDO2

APCH105A

GDS0205

5

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012

2014-

11

06-

16

24

16NOV2012

24JUN2014

1

-5

NO

Y

1

DR. JOHN SMITH

			USA	North America	1
6	STUDYX	X-

101

100-P0001

101

100

6

Y

DRUG A + SOC

GDS02-Afraid of Something Bad Happening

APCH1-Oxygenation: PaO2

APCH105B

GDS0206

6

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	61-70	mmHg	Y		1		Y	USA	North America	1
7	STUDYX	X-

101

100-P0001

101

100

7

Y

DRUG A + SOC

GDS02-Feel Happy Most of Time

APCH1-Arterial pH

APCH106A

GDS0207

7

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012

2014-

11

06-

16

24

16NOV2012

1

NO

1

DR. JOHN SMITH

24JUN2014	-5	7.15-7.24		Y		3		Y	USA	North America	1
8	STUDYX	X-

101

100-P0001

101

100

8

Y

DRUG A + SOC

GDS02-Often Feel Helpless

APCH1-Serum HCO3

APCH106B

GDS0208

8

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

2014-06-24	24JUN2014	-5				Y				USA	North America	1
9	STUDYX	X-

101

100-P0001

101

100

9

Y

DRUG A + SOC

GDS02-Prefer to Stay Home

APCH1-Serum Sodium

APCH107

GDS0209

9

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

2014-06-24

24JUN2014

-5

150-154

mmol/L

Y

16NOV2012

1

NO

0

Y

USA

North America

1

DR. JOHN SMITH


10	STUDYX	X-

101

100-P0001

101

100

10

Y

DRUG A + SOC

GDS02

APCH1-

Memory Problems

Serum Potassium

GDS0210

APCH108

10

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	3.5-5.4	mmol/L	Y		0		Y	USA	North America	1
11	STUDYX	X-

101

100-P0001

101

100

11

Y

DRUG A + SOC

GDS02-Wonderful to Be Alive

APCH1-Serum Creatinine

APCH109

GDS0211

11

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

NO

1

DR. JOHN SMITH

2014-06-24

24JUN2014

-5

<0.6

mg/dL

Y

2

Y

USA

North America

1

12

STUDYX

X-

101

100-P0001

101

100

12

Y

DRUG A + SOC

GDS02

APCH1-

Feel Worthless

Hematocrit

GDS0212

APCH110

12

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012

2014-

11

06-

16

24

16NOV2012

24JUN2014

1

YES

1

DR. JOHN SMITH

-5	20-29.9	%	Y		2		Y	USA	North America	1
13	STUDYX	X-

101

100-P0001

101

100

13

Y

DRUG A + SOC

GDS02-Feel Full of Energy

APCH1-White Blood Count

APCH111

GDS0213

13

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

0

2014-06-24

24JUN2014

-5

20-39.9

10^9/L

Y

2

Y

USA

North America

1

DR. JOHN SMITH


14	STUDYX	X-

101

100-P0001

101

100

14

Y

DRUG A + SOC

GDS02-Feel Hopeless

APCH1-15 Minus Glasgow Coma Score

APCH112

GDS0214

14

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

YES

1

DR. JOHN SMITH

2014-06-24	24JUN2014	-5	3		Y		3		Y	USA	North America	1
15	STUDYX	X-

101

100-P0001

101

100

15

Y

DRUG A + SOC

GDS02-Most People Better Off Than You

APCH1-A: Total Acute Physiology Score

APCH113

GDS0215

15

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012-11-16

16NOV2012

1

NO

0

2014-06-24

24JUN2014

-5

18

Y

18

Y

USA

North America

1

DR. JOHN SMITH


16	STUDYX	X-

101

100-P0001

101

100

16

Y

DRUG A + SOC

GDS02

APCH1-A: Total Acute Physiology Score - Analysis

GDS02TS

APCH1TPS

16

GDS SHORT FORM

APACHE II

SCREENING

VISIT 1

1

BASELINE

Baseline

0

2012

2014-

11

06-

16

24

16NOV2012

24JUN2014

1

-5

10

Y

Possible Depression

18

10

Y

USA

Y

DR. JOHN SMITH

North America	1
17	STUDYX	X-

101

100-P0001

101

100

16

17

Y

DRUG A + SOC

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

0

DR. JOHN SMITH

18

STUDYX

X-101-P0001

APCH1-B: Age Points	APCH114	17	APACHE II	SCREENING	1	Baseline	0	2014-06-24	24JUN2014	-5	45-54	YEARS	Y		2		Y	USA	North America	1
18	STUDYX	X-100-P0001	100

101

17

18

Y

DRUG A + SOC

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0

APCH1-C: Chronic Health Points

APCH115

18

APACHE II

SCREENING

1

Baseline

0

2014-06-24

24JUN2014

-5

for elective postoperative patients

Y

2

Y

USA

North America

1

DR. JOHN SMITH


19	STUDYX	X-

101

100-P0001

101

100

18

19

Y

DRUG A + SOC

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0

APCH1-Total APACHE II Score

APCH116

19

APACHE II

SCREENING

1

Baseline

0

2014-06-24

24JUN2014

-5

22

Y

22

Y

USA

North America

1

DR. JOHN SMITH


20	STUDYX	X-

10119

100-P0001

101

100

20

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1

DR. JOHN SMITH

21

STUDYX

X-101-P0001

101

+ SOC	APCH1-Total APACHE II Score - Analysis	APCH1TS	20	APACHE II	SCREENING	1	Baseline	0	2014-06-24	24JUN2014	-5			Y		22		Y	USA	North America	1
21	STUDYX	X-100-P0001	100	19

20

21

Y

DRUG A + SOC

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1

APCH1-Temperature - Rectal

APCH101

1

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

38.5-38.9

C

1

USA

North America

1

DR. JOHN SMITH


22	STUDYX	X-

101

100-P0001

101

100

21

20

22

Y

DRUG A + SOC

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1

APCH1-Mean Arterial Pressure

APCH102

2

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

70–109

mmHg

0

USA

North America

1

DR. JOHN SMITH


23	STUDYX	X-

101

100-P0001

101

100

22

21

23

Y

DRUG A + SOC

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1

DR. JOHN SMITH

APCH1-Heart Rate	APCH103	3	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	70-109	beats/min			0			USA	North America	1
24	STUDYX	X-

101

100-P0001

101

100

23

22

24

Y

DRUG A + SOC

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1

DR. JOHN SMITH

APCH1-Respiratory Rate	APCH104	4	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	25-34	breaths/min			1			USA	North America	1
25	STUDYX	X-

101

100-P0001

101

100

24

23

25

Y

DRUG A

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0

+ SOC

APCH1-Oxygenation: A-aDO2

APCH105A

5

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

Y

USA

North America

1

DR. JOHN SMITH


26	STUDYX	X-

101

100-P0001

101

100

25

24

26

Y

DRUG A + SOC

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0

DR. JOHN SMITH

APCH1-Oxygenation: PaO2	APCH105B	6	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	61-70	mmHg			1			USA	North America	1
27	STUDYX	X-

101

100-P0001

101

100

26

25

27

Y

DRUG A + SOC

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

1

DR. JOHN SMITH

APCH1-Arterial pH	APCH106A	7	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	7.25-7.32				2			USA	North America	1
28	STUDYX	X-

101

100-P0001

101

100

27

26

28

Y

DRUG A + SOC

GDS02

APCH1-

Feel Worthless

Serum HCO3

GDS0212

APCH106B

12

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1

DR. JOHN SMITH

8	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7				Y				USA	North America	1
29	STUDYX	X-

101

100-P0001

101

100

28

27

29

Y

DRUG A + SOC

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

0

APCH1-Serum Sodium

APCH107

9

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

150-154

mmol/L

1

USA

North America

1

DR. JOHN SMITH


30	STUDYX	X-

101

100-P0001

101

100

29

28

30

Y

DRUG A + SOC

GDS02

APCH1-

Feel Hopeless

Serum Potassium

GDS0214

APCH108

14

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

YES

1

DR. JOHN SMITH

10	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	3.5-5.4	mmol/L			0			USA	North America	1
31	STUDYX	X-

101

100-P0001

101

100

30

29

31

Y

DRUG A + SOC

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

NO

0

APCH1-Serum Creatinine

APCH109

11

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

0.6-1.4

mg/dL

0

USA

North America

1

DR. JOHN SMITH


32	STUDYX	X-

101

100-P0001

101

100

30

32

Y

DRUG A + SOC

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 2

2

VISIT 2

2

2012-12-15

15DEC2012

30

8

Possible Depression

10

-2

Y

DR. JOHN SMITH

APCH1-Hematocrit	APCH110	12	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	20-29.9	%			2			USA	North America	1
33	STUDYX	X-

101

100-P0001

101

100

31

33

Y

DRUG A + SOC

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

0

APCH1-White Blood Count

APCH111

13

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

15-19.9

10^9/L

1

USA

North America

1

DR. JOHN SMITH


34	STUDYX	X-

101

100-P0001

101

100

32

34

Y

DRUG A + SOC

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0

APCH1-15 Minus Glasgow Coma Score

APCH112

14

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

1

USA

North America

1

DR. JOHN SMITH


35	STUDYX	X-

101

100-P0001

101

100

33

35

Y

DRUG A + SOC

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

APCH1-A: Total Acute Physiology Score

APCH113

15

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

10

USA

North America

1

DR. JOHN SMITH


36	STUDYX	X-

101

100-P0001

101

100

34

36

Y

DRUG A

GDS02-Bored Often

GDS0204

4

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

DR. JOHN SMITH

+ SOC	APCH1-A: Total Acute Physiology Score - Analysis	APCH1TPS	16	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7					10			USA	North America	1
37	STUDYX	X-

101

100-P0001

101

100

35

34

37

Y

DRUG A + SOC

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

1

DR. JOHN SMITH

APCH1-B: Age Points	APCH114	17	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	45-54	YEARS			2			USA	North America	1
38	STUDYX	X-

101

100-P0001

101

100

36

35

38

Y

DRUG A + SOC

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

DR. JOHN SMITH

APCH1-C: Chronic Health Points	APCH115	18	APACHE II	DAY 7	7	Day 7	7	2014-07-05	05JUL2014	7	for elective postoperative patients				2			USA	North America	1
39	STUDYX	X-

101

100-P0001

101

100

37

36

39

Y

DRUG A + SOC

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0

APCH1-Total APACHE II Score

APCH116

19

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

14

USA

North America

1

DR. JOHN SMITH


40	STUDYX	X-

10138

100-P0001

101

100

40

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

+ SOC

APCH1-Total APACHE II Score - Analysis

APCH1TS

20

APACHE II

DAY 7

7

Day 7

7

2014-07-05

05JUL2014

7

14

USA

North America

1

DR. JOHN SMITH


41	STUDYX	X-

101

100-P0001

101

100

39

37

41

Y

DRUG A + SOC

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0

APCH1-Temperature - Rectal

APCH101

1

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

36-38.4

C

0

USA

North America

1

DR. JOHN SMITH


42	STUDYX	X-

101

100-P0001

101

100

40

38

42

Y

DRUG A + SOC

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0

APCH1-Mean Arterial Pressure

APCH102

2

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

70–109

mmHg

0

USA

North America

1

DR. JOHN SMITH


43	STUDYX	X-

101

100-P0001

101

100

41

39

43

Y

DRUG A + SOC

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

1

APCH1-Heart Rate

APCH103

3

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

70-109

beats/min

0

USA

North America

1

DR. JOHN SMITH


44	STUDYX	X-

101

100-P0001

101

100

42

40

44

Y

DRUG A + SOC

GDS02

APCH1-

Feel Worthless

Respiratory Rate

GDS0212

APCH104

12

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

4

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

12–24

breaths/min

0

USA

North America

1

DR. JOHN SMITH


45	STUDYX	X-

101

100-P0001

101

100

43

41

45

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

0

+ SOC

APCH1-Oxygenation: A-aDO2

APCH105A

5

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

Y

USA

North America

1

DR. JOHN SMITH


46	STUDYX	X-

101

100-P0001

101

100

44

42

46

Y

DRUG A + SOC

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

YES

1

APCH1-Oxygenation: PaO2

APCH105B

6

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

61-70

mmHg

1

USA

North America

1

DR. JOHN SMITH


47	STUDYX	X-

101

100-P0001

101

100

45

43

47

Y

DRUG A + SOC

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

NO

0

APCH1-Arterial pH

APCH106A

7

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

7.33-7.49

0

USA

North America

1

DR. JOHN SMITH


48	STUDYX	X-

101

100-P0001

101

100

46

44

48

Y

DRUG A + SOC

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

UNSCHEDULED 2.01

2.01

UNSCHEDULED 2.01

2

2012-12-28

28DEC2012

43

9

Possible Depression

10

-1

DR. JOHN SMITH

APCH1-Serum HCO3

APCH106B

8

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

Y

USA

North America

1

49

STUDYX

X-

101

100-P0001

100

101

45

49

Y

DRUG A + SOC

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

0.46

AVERAGE

DR. JOHN SMITH

50

STUDYX

X-101-P0001

APCH1-Serum Sodium	APCH107	9	APACHE II	DAY 15	15	Day 15 (Day of Discharge)	15	2014-07-13	13JUL2014	15	130-149	mmol/L			0			USA	North America	1
50	STUDYX	X-100-P0001	100	46

101

50

Y

DRUG A + SOC

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

0.46

AVERAGE

APCH1-Serum Potassium

APCH108

10

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

3.5-5.4

mmol/L

0

USA

North America

1

DR. JOHN SMITH


51	STUDYX	X-

101

100-P0001

101

100

47

51

Y

DRUG A + SOC

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0

APCH1-Serum Creatinine

APCH109

11

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

0.6-1.4

mg/dL

0

USA

North America

1

DR. JOHN SMITH


52	STUDYX	X-

101

100-P0001

101

100

48

52

Y

DRUG A + SOC

GDS02

APCH1-

Bored Often

Hematocrit

GDS0204

APCH110

4

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0

12

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

46-49.9

%

1

USA

North America

1

DR. JOHN SMITH


53	STUDYX	X-

101

100-P0001

101

100

49

53

Y

DRUG A + SOC

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

0

APCH1-White Blood Count

APCH111

13

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

3-14.9

10^9/L

0

USA

North America

1

DR. JOHN SMITH


54	STUDYX	X-

101

100-P0001

101

100

50

54

Y

DRUG A + SOC

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1

DR. JOHN SMITH

APCH1-15 Minus Glasgow Coma Score	APCH112	14	APACHE II	DAY 15	15	Day 15 (Day of Discharge)	15	2014-07-13	13JUL2014	15	0				0			USA	North America	1
55	STUDYX	X-

101

100-P0001

101

100

51

55

Y

DRUG A + SOC

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

1

DR. JOHN SMITH

APCH1-A: Total Acute Physiology Score	APCH113	15	APACHE II	DAY 15	15	Day 15 (Day of Discharge)	15	2014-07-13	13JUL2014	15	2				2			USA	North America	1
56	STUDYX	X-

10152

100-P0001

101

100

56

Y

DRUG A

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1

+ SOC

APCH1-A: Total Acute Physiology Score - Analysis

APCH1TPS

16

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

2

USA

North America

1

DR. JOHN SMITH


57	STUDYX	X-

101

100-P0001

101

100

53

52

57

Y

DRUG A + SOC

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0

APCH1-B: Age Points

APCH114

17

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

45-54

YEARS

2

USA

North America

1

DR. JOHN SMITH


58	STUDYX	X-

101

100-P0001

101

100

54

53

58

Y

DRUG A + SOC

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0

APCH1-C: Chronic Health Points

APCH115

18

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

for elective postoperative patients

2

USA

North America

1

DR. JOHN SMITH


59	STUDYX	X-

101

100-P0001

101

100

55

54

59

Y

DRUG A + SOC

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

1

APCH1-Total APACHE II Score

APCH116

19

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

6

USA

North America

1

DR. JOHN SMITH


60	STUDYX	X-

10156

100-P0001

101

100

60

Y

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1

+ SOC

APCH1-Total APACHE II Score - Analysis

APCH1TS

20

APACHE II

DAY 15

15

Day 15 (Day of Discharge)

15

2014-07-13

13JUL2014

15

6

USA

North America

1

DR. JOHN SMITH


61	STUDYX	X-

101

200-

P0001

P0002

101

200

57

1

61

1

Y

DRUG A

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

0

DR. JOHN SMITH

SOC

APCH1-Temperature - Rectal

APCH101

1

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

38.5-38.9

C

Y

1

Y

GBR

Non-North America

0

62

STUDYX

X-

101

200-

P0001

P0002

101

200

58

2

62

2

Y

DRUG A

SOC

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

YES

1

APCH1-Mean Arterial Pressure

APCH102

2

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

110-129

mmHg

Y

2

Y

GBR

Non-North America

0

DR. JOHN SMITH


63	STUDYX	X-

101

200-

P0001

P0002

101

200

59

3

63

3

Y

DRUG A

SOC

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

NO

0

DR. JOHN SMITH

APCH1-Heart Rate	APCH103	3	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	70-109	beats/min	Y		0		Y	GBR	Non-North America	0
64	STUDYX	X-200-P0002	200	4	4	Y	SOC	APCH1-Respiratory Rate	APCH104	4	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	>=50	breaths/min	Y		4		Y	GBR	Non-North America	0

64

STUDYX

X-101-P0001

101

64

Y

DRUG A

GDS02- Total Score - Analysis

GDS02TS

16

GDS SHORT FORM

VISIT 3

3

VISIT 3

3

2013-01-12

12JAN2013

58

7

Possible Depression

10

-3

AVERAGE

Y

DR. JOHN SMITH


65	STUDYX	X-

101

200-

P0001

P0002

101

200

60

5

65

5

Y

DRUG A

GDS02-Satisfied With Life

GDS0201

1

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0

DR. JOHN SMITH

SOC

APCH1-Oxygenation: A-aDO2

APCH105A

5

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

Y

GBR

Non-North America

0

66

STUDYX

X-

101

200-

P0001

P0002

101

200

61

6

66

6

Y

DRUG A

SOC

GDS02-Dropped Activities and Interests

GDS0202

2

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

APCH1-Oxygenation: PaO2	APCH105B	6	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	61-70	mmHg	Y		1		Y	GBR	Non-North America	0
67	STUDYX	X-

101

200-

P0001

P0002

101

200

62

7

67

7

Y

DRUG A

SOC

GDS02-Life Is Empty

GDS0203

3

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

APCH1-Arterial pH

APCH106A

7

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

<7.15

Y

4

Y

GBR

Non-North America

0

DR. JOHN SMITH


68	STUDYX	X-

101

200-

P0001

P0002

101

200

63

8

68

8

Y

DRUG A

SOC

GDS02

APCH1-

Bored Often

Serum HCO3

GDS0204

APCH106B

4

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

8	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2				Y				GBR	Non-North America	0
69	STUDYX	X-

101

200-

P0001

P0002

101

200

64

9

69

9

Y

DRUG A

SOC

GDS02-Good Spirits Most of Time

GDS0205

5

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0

DR. JOHN SMITH

APCH1-Serum Sodium	APCH107	9	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	150-154	mmol/L	Y		1		Y	GBR	Non-North America	0
70	STUDYX	X-

101

200-

P0001

P0002

101

200

65

10

70

10

Y

DRUG A

SOC

GDS02-Afraid of Something Bad Happening

GDS0206

6

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

1

APCH1-Serum Potassium

APCH108

10

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

3.5-5.4

mmol/L

Y

0

Y

GBR

Non-North America

0

DR. JOHN SMITH


71	STUDYX	X-

101

200-

P0001

P0002

101

200

66

11

71

11

Y

DRUG A

SOC

GDS02-Feel Happy Most of Time

GDS0207

7

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

1

APCH1-Serum Creatinine

APCH109

11

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

<0.6

mg/dL

Y

2

Y

GBR

Non-North America

0

DR. JOHN SMITH


72	STUDYX	X-

101

200-

P0001

P0002

101

200

67

12

72

12

Y

DRUG A

SOC

GDS02-Often Feel Helpless

GDS0208

8

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

APCH1-Hematocrit

APCH110

12

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

20-29.9

%

Y

2

Y

GBR

Non-North America

0

DR. JOHN SMITH


73	STUDYX	X-

101

200-

P0001

P0002

101

200

68

13

73

13

Y

DRUG A

SOC

GDS02-Prefer to Stay Home

GDS0209

9

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

APCH1-White Blood Count

APCH111

13

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

>=40

10^9/L

Y

4

Y

GBR

Non-North America

0

74

STUDYX

X-

101

200-

P0001

P0002

101

200

69

14

74

14

Y

DRUG A

SOC

GDS02-Memory Problems

GDS0210

10

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

APCH1-15 Minus Glasgow Coma Score	APCH112	14	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	3		Y		3		Y	GBR	Non-North America	0
75	STUDYX	X-

101

200-

P0001

P0002

101

200

70

15

75

15

Y

DRUG A

SOC

GDS02-Wonderful to Be Alive

GDS0211

11

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

1

APCH1-A: Total Acute Physiology Score

APCH113

15

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

24

Y

24

Y

GBR

Non-North America

0

DR. JOHN SMITH


76	STUDYX	X-

101

200-

P0001

P0002

101

200

71

16

76

Y

SOC

DRUG A

GDS02-Feel Worthless

GDS0212

12

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

APCH1-A: Total Acute Physiology Score - Analysis	APCH1TPS	16	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2			Y		24		Y	GBR	Non-North America	0
77	STUDYX	X-

101

200-

P0001

P0002

101

200

72

16

77

17

Y

DRUG A

SOC

GDS02-Feel Full of Energy

GDS0213

13

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

YES

0

DR. JOHN SMITH

APCH1-B: Age Points	APCH114	17	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2	65-74	YEARS	Y		5		Y	GBR	Non-North America	0
78	STUDYX	X-

101

200-

P0001

P0002

101

200

73

17

78

18

Y

DRUG A

SOC

GDS02-Feel Hopeless

GDS0214

14

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

DR. JOHN SMITH

APCH1-C: Chronic Health Points

APCH115

18

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

for elective postoperative patients

Y

2

Y

GBR

Non-North America

0

79

STUDYX

X-

101

200-

P0001

P0002

101

200

74

18

79

19

Y

DRUG A

SOC

GDS02-Most People Better Off Than You

GDS0215

15

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

NO

0

APCH1-Total APACHE II Score

APCH116

19

APACHE II

SCREENING

1

Baseline

0

2014-08-03

03AUG2014

-2

31

Y

31

Y

GBR

Non-North America

0

DR. JOHN SMITH


80	STUDYX	X-

101

200-

P0001

P0002

101

200

80

20

Y

DRUG A

SOC

GDS02

APCH1-Total APACHE II Score - Analysis

GDS02TS

APCH1TS

16

GDS SHORT FORM

VISIT 4

4

VISIT 4

4

2013-02-13

13FEB2013

90

3

Normal

10

-7

Y

DR. JOHN SMITH

20	APACHE II	SCREENING	1	Baseline	0	2014-08-03	03AUG2014	-2			Y		31		Y	GBR	Non-North America	0
81	STUDYX	X-

101

200-

P0001

P0002

101

200

81

21

Y

DRUG A

SOC

GDS02

APCH1-Total APACHE II Score - Analysis

GDS02TS

APCH1TS

16

GDS SHORT FORM

VISIT 4

4

ENDPOINT

7

2013-02-13

13FEB2013

90

3

Normal

10

-7

LOV

Y

DR. JOHN SMITH

20

APACHE II

Day 15 (Day of Discharge)

15

09AUG2014

5

38

WOC

GBR

Non-North America

0

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