abs as 301 blindedpatientdetailreport 05 jun 2013

8/22/2019 ABS as 301 BlindedPatientDetailReport 05 Jun 2013

1/28

Site

Number

Screening

Number

Date of

Birth

Adolescent Informed Consent

Date

Screening

Date

Run - In Date

10001 10001001 06/Aug/1

975

No 18/Jan/2013

10001 10001002 01/Sep/1

972

No 18/Jan/2013 18/Jan/2013 18/Jan/2013

10001 10001003 07/May/1999

Yes 18/Jan/2013

10001 10001004 06/Oct/19

82

No 23/Jan/2013 23/Jan/2013 23/Jan/2013

10001 10001005 09/Dec/1

990

No 28/Jan/2013

10001 10001006 05/Apr/20

06

No

10001 10001007 06/Aug/1

975

No 18/Jan/2013 20/Jan/2013 16/Jan/2013

10001 10001008 07/Jul/19

93

No 09/Jan/2013 23/Jan/2013

10001 10001009 06/Aug/1

975

No 18/Jan/2013 24/Jan/2013

10001 10001010 05/May/1

980

No 17/Jan/2013 25/Jan/2013

10001 10001011 05/May/1

980

No 17/Jan/2013 24/Jan/2013

10001 10001012 04/Jun/19

93

No 28/Jan/2013 06/Feb/2013

10001 10001013 03/Mar/2

007

No

10001 10001014 06/Aug/1

968

No 29/Jan/2013 30/Jan/2013

10001 10001015 04/Jul/19

94

No 16/Jan/2013 18/Jan/2013

10001 10001016 04/Apr/19

92

No 15/Jan/2013 16/Jan/2013 29/Jan/2013

10001 10001017 04/Feb/1

996

Yes 23/Jan/2013

10001 10001018 04/May/1

989

No 15/Jan/2013

10001 10001019 09/Aug/1

992

No 30/Jan/2013 30/Jan/2013 30/Jan/2013

10001 10001020 09/Aug/1992

No 30/Jan/2013 30/Jan/2013 30/Jan/2013

10001 10001021 28/Jun/19

90

No 30/Jan/2013 30/Jan/2013

10001 10001022 09/Jun/19

83

No 16/Jan/2013 24/Jan/2013 30/Jan/2013

10001 10001023 06/Aug/1

975

No 18/Jan/2013 24/Jan/2013


2/28

10001 10001024 11/Sep/1

954

No 21/Jan/2013 22/Jan/2013 31/Jan/2013

10001 10001025 12/Oct/19

58

No 23/Jan/2013 24/Jan/2013

10001 10001026 11/Sep/1

954

No 21/Jan/2013 31/Jan/2013

10001 10001027 11/Sep/1968

No 21/Jan/2013 22/Jan/2013 16/Jan/2013

10001 10001028 12/Sep/1

963

No 21/Jan/2013 22/Jan/2013

10001 10001029 06/Aug/1

975

No 18/Jan/2013 23/Jan/2013

10001 10001030 11/Sep/1

954

No 21/Jan/2013 31/Jan/2013 19/Jan/2013

10001 10001031 10/Oct/19

94

No 23/Jan/2013 31/Jan/2013

10001 10001032 05/May/1

980

No 17/Jan/2013 27/Jan/2013

10001 10001033 11/Sep/1

970

No 30/Jan/2013 01/Feb/2013

10001 10001034 10/Oct/19

94

No 23/Jan/2013 01/Feb/2013 04/Feb/2013

10001 10001035 11/Sep/1

970

No 30/Jan/2013 01/Feb/2013

10001 10001036 03/Feb/1

977

No 07/Feb/2013 07/Feb/2013

10001 10001037 02/Feb/1

978

No 07/Feb/2013 07/Feb/2013

10001 10001038 02/Feb/1

970

No 07/Feb/2013 07/Feb/2013

10001 10001039 02/Feb/1

990

No 08/Feb/2013 11/Feb/2013 12/Feb/2013

10001 10001040 02/Feb/1

982

No 08/Feb/2013 08/Feb/2013

10001 10001041 04/Oct/19

82

No 12/Feb/2013 12/Feb/2013 12/Feb/2013

10001 10001042 06/Aug/1

987

No 05/Feb/2013 06/Feb/2013

10001 10001043 02/Apr/19

73

No 12/Feb/2013

10001 10001044 06/Aug/1991

No 12/Feb/2013

10001 10001045 11/Sep/1

970

No 04/Feb/2013 04/Feb/2013 20/Feb/2013

10001 10001046 09/Aug/1

971

No 06/Feb/2013 06/Mar/2013

10001 10001047 05/Jul/19

85

No 15/Feb/2013 15/Mar/2013


3/28

10001 10001048 16/Sep/1

975

No 20/Feb/2013 20/Feb/2013

10001 10001049 12/Jul/19

76

No 20/Feb/2013 20/Feb/2013

10001 10001050 16/Jun/19

83

No 20/Feb/2013

10001 10001051 14/Aug/1

980

No 20/Feb/2013 20/Feb/2013

10001 10001052 04/Jun/19

75

No 20/Feb/2013 18/Mar/2013

10001 10001053 07/Apr/19

95

Yes 04/Mar/2013 04/Mar/2013

10001 10001054 04/May/1

997

Yes 01/Mar/2013 02/Mar/2013

10001 10001055 05/Nov/1

978

No 14/Mar/2013

10001 10001056 06/Aug/1

970

No 18/Mar/2013

10001 10001057 02/Feb/1

991

No 18/Mar/2013 18/Mar/2013 18/Mar/2013

10001 10001058 08/Jul/19

93

No 18/Mar/2013 18/Mar/2013

10001 10001059 04/Jul/19

82

No 18/Mar/2013 18/Mar/2013 18/Mar/2013

10001 10001060 03/May/1

985

No 18/Mar/2013 18/Mar/2013

10001 10001061 03/May/1

985

No 18/Mar/2013 18/Mar/2013

10001 10001062 04/Mar/1

991

No 18/Mar/2013 18/Mar/2013

10001 10001063 02/Aug/1

982

No 18/Mar/2013 18/Mar/2013

10001 10001064 04/Jun/19

80

No 20/Mar/2013 20/Mar/2013

10001 10001065 03/Apr/19

83

No 20/Mar/2013

10001 10001066 07/Sep/1

970

No 20/Mar/2013 20/Mar/2013

10001 10001067 04/Jun/19

82

No 20/Mar/2013

10001 10001068 04/Aug/1

989

No 20/Mar/2013 18/Apr/2013

10001 10001069 10/Oct/19

78

No 20/Mar/2013 20/Mar/2013

10001 10001070 09/Sep/1

985

No 20/Mar/2013 21/Mar/2013 21/Mar/2013

10001 10001071 02/Mar/1

985

No 20/Mar/2013 20/Mar/2013

10001 10001072 05/Jun/19

82

No 20/Mar/2013


4/28

10001 10001073 05/Jun/19

91

No 20/Mar/2013

10001 10001074 02/May/1

989

No 21/Mar/2013

10001 10001075 05/Apr/19

87

No 24/Mar/2013

10001 10001076 04/Feb/1989

No 24/Mar/2013 24/Mar/2013

10001 10001077 04/Apr/19

86

No 24/Mar/2013 24/Mar/2013

10001 10001078 12/Dec/1

975

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001079 12/Aug/1

981

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001080 08/Jan/19

86

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001081 08/Aug/1

986

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001082 02/Apr/1986 No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001083 05/Jul/19

80

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001084 05/Sep/1

980

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001085 03/Jul/19

80

No 24/Mar/2013

10001 10001086 06/Jun/19

90

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001087 12/Oct/19

73

No 24/Mar/2013 24/Mar/2013 24/Mar/2013

10001 10001088 01/Jan/19

80

No 25/Mar/2013 25/Mar/2013 25/Mar/2013

10001 10001089 04/Jun/19

90

No 25/Mar/2013 25/Mar/2013 25/Mar/2013

10001 10001090 05/Oct/19

80

No 25/Mar/2013 25/Mar/2013 25/Mar/2013

10001 10001091 12/May/1

970

No 27/Mar/2013 27/Mar/2013

10001 10001092 01/Aug/1

980

No 28/Mar/2013 28/Mar/2013 28/Mar/2013

10001 10001093 06/Jun/19

83

No 28/Mar/2013 28/Mar/2013

10001 10001094 07/Mar/1

977

No 28/Mar/2013 28/Mar/2013

10001 10001095 15/Oct/19

73

No 28/Mar/2013 28/Mar/2013

10001 10001096 15/Oct/19

73

No 28/Mar/2013 28/Mar/2013

10001 10001097 08/Jul/19

78

No 08/Apr/2013

10001 10001098 02/Feb/1

975

No 08/Apr/2013


5/28

10001 10001099 04/Jul/19

88

No 08/Apr/2013

10001 10001100 04/Nov/1

985

No 08/Apr/2013

10001 10001101 05/Jun/19

83

No 08/Apr/2013

10001 10001102 03/Aug/1990

No 10/Apr/2013 10/Apr/2013

10001 10001103 11/Jun/19

85

No 11/Apr/2013

10001 10001104 06/Jul/19

78

No

10001 10001105 07/Jun/19

95

Yes 01/May/2013

10002 10002001 03/Apr/19

92

No 05/Jan/2013

10002 10002002 03/Apr/19

92

No 05/Jan/2013 24/Jan/2013

10002 10002003 03/Feb/1976 No 29/Jan/2013 29/Jan/2013

10002 10002004 03/Feb/1

976

No 29/Jan/2013 04/Feb/2013

10002 10002005 04/Apr/19

77

No 23/Jan/2013 25/Jan/2013 29/Jan/2013

10002 10002006 04/Apr/19

77

No 23/Jan/2013 29/Jan/2013

10002 10002007 04/Apr/19

77

No 23/Jan/2013 29/Jan/2013 03/Feb/2013

10002 10002008 02/Feb/1

972

No 29/Jan/2013 01/Feb/2013

10002 10002009 02/Feb/1

980

No 29/Jan/2013 29/Jan/2013 29/Jan/2013

10002 10002010 02/Feb/1

984

No 28/Jan/2013 28/Jan/2013

10002 10002011 02/Feb/1

980

No 29/Jan/2013 30/Jan/2013 04/Feb/2013

10002 10002012 03/Feb/1

976

No 29/Jan/2013 01/Feb/2013

10002 10002013 09/Sep/1

974

No 01/Feb/2013 02/Feb/2013

10002 10002014 04/Apr/19

77

No 23/Jan/2013 03/Feb/2013

10002 10002015 04/Apr/19

77

No 01/Feb/2013 05/Feb/2013 07/Feb/2013

10002 10002016 12/Jul/19

79

No 07/Feb/2013 07/Feb/2013 10/Feb/2013

10002 10002017 12/Aug/1

958

No 04/Feb/2013 05/Feb/2013


6/28

10002 10002018 11/Sep/1

976

No 05/Feb/2013 05/Feb/2013

10002 10002019 11/Nov/1

949

No 03/Feb/2013 05/Feb/2013

10002 10002020 08/Aug/1

997

Yes 04/Feb/2013 05/Feb/2013 10/Feb/2013

10002 10002021 11/Sep/1

952

No 04/Feb/2013 05/Feb/2013

10002 10002022 04/Apr/19

77

No 23/Jan/2013 11/Feb/2013

10003 10003001 07/May/1

981

No 27/Jan/2013 01/Feb/2013 03/Feb/2013

10003 10003002 09/Sep/1

960

No 04/Feb/2013 05/Feb/2013 07/Feb/2013

10003 10003003 12/Sep/1

966

No 04/Feb/2013 05/Feb/2013

10003 10003004 09/Jul/20

01

No

10003 10003005 12/Jul/19

97

Yes 05/Feb/2013 06/Feb/2013

10003 10003006 11/Dec/1

996

Yes 05/Feb/2013

10003 10003007 09/Jun/19

96

Yes 04/Feb/2013

10003 10003008 10/Aug/1

972

No 05/Feb/2013 06/Feb/2013

10003 10003009 11/Dec/1

967

No 05/Feb/2013 08/Feb/2013

10003 10003010 04/Apr/19

74

No 11/Feb/2013 11/Feb/2013 11/Feb/2013

10003 10003011 04/Apr/19

84

No 11/Feb/2013 11/Feb/2013 11/Feb/2013

10003 10003012 02/Feb/1

982

No 11/Feb/2013 13/Feb/2013

10003 10003013 02/Feb/1

984

No 11/Feb/2013 11/Feb/2013

10003 10003014 03/Mar/1

982

No 11/Feb/2013

10003 10003015 06/Oct/1987

No 12/Jan/2013 12/Jan/2013 12/Jan/2013

10003 10003016 02/Feb/1

982

No 11/Feb/2013 13/Feb/2013

10003 10003017 03/Jul/19

85

No 27/Mar/2013 27/Mar/2013 27/Mar/2013

10003 10003018 20/Mar/1

960

No 27/Mar/2013 27/Mar/2013 27/Mar/2013


7/28

10003 10003019 10/Nov/1

950

No 27/Mar/2013 27/Mar/2013

10003 10003020 06/Sep/1

970

No 28/Mar/2013 28/Mar/2013

10004 10004001 10/Jul/19

95

Yes 12/Feb/2013 12/Feb/2013 13/Feb/2013

10004 10004002 07/Nov/1990

No 27/Mar/2013 27/Mar/2013 27/Mar/2013

10004 10004003 09/Feb/1

970

No 27/Mar/2013 27/Mar/2013

10004 10004004 05/Feb/1

982

No 27/Mar/2013

10004 10004005 09/Oct/19

60

No 27/Mar/2013 27/Mar/2013

10004 10004006 05/Sep/1

975

No 27/Mar/2013 27/Mar/2013

10004 10004007 07/Dec/1

955

No 28/Mar/2013 28/Mar/2013 28/Mar/2013

10008 10008001 08/Nov/1

948

No 04/Feb/2013 05/Feb/2013

10008 10008002 09/Sep/1

957

No 04/Feb/2013 19/Feb/2013

10008 10008003 14/Sep/2

002

No

10010 10010001 09/Sep/1

968

No 04/Feb/2013

10010 10010002 12/Sep/1

997

Yes 12/Feb/2013 12/Feb/2013

10010 10010003 12/Sep/1

971

No 04/Feb/2013 05/Feb/2013 12/Feb/2013

10010 10010004 12/Aug/1

996

Yes 04/Feb/2013 05/Feb/2013

10010 10010005 10/Sep/1

982

No 06/Feb/2013 12/Feb/2013

10010 10010006 10/Sep/1

967

No 11/Feb/2013 12/Feb/2013

10010 10010007 11/Aug/1

972

No 04/Feb/2013


8/28

Screen Failed

Date

Screen Fail Reason Randomization

Date

Randomization

Number

Last Visit

Completed23/Jan/2013 Subject developed

Respiratory Infection

IC

18/Jan/2013 50001 TV1.1

24/Jan/2013 Subject developedRespiratory Infection

IC

23/Jan/2013 50002 TV1

30/Jan/2013 Subject did not meet

inclusion/exclusion

criteria

IC

28/Jan/2013 IC

17/Jan/2013 Subject developed


SV/Run-In

23/Jan/2013 Subject withdrew written

informed consent

SV



SV



SV

12/Feb/2013 Subject withdrew written

informed consent

SV


informed consent

SV

15/Jan/2013 IC


informed consent

SV

29/Jan/2013 Subject did not meet

inclusion/exclusion

criteria

SV

12/Feb/2013 Subject did not meet

inclusion/exclusion

criteria

SV/Run-In


informed consent

IC


informed consent

IC



SV/Run-In

05/Mar/2013 Subject did not meetinclusion/exclusion

criteria

SV/Run-In

07/Feb/2013 SV/Run-In

12/Mar/2013 Subject withdrew written

informed consent

SV/Run-In


informed consent

SV


9/28

31/Jan/2013 50003 TV4



SV



SV

26/Jan/2013 50005 TV1

06/Feb/2013 Subject developed


SV


inclusion/exclusion

criteria

SV

31/Jan/2013 50004 TV1



SV




SV


informed consent

SV/Run-In




SV


informed consent

SV


inclusion/exclusion

criteria

SV


inclusion/exclusion

criteria

SV/Run-In



informed consent

SV/Run-In


informed consent

SV


informed consent

IC

12/Feb/2013 Subject did not meetinclusion/exclusion

criteria

IC

18/Mar/2013 50006 TV2


informed consent

SV


informed consent

SV


10/28


informed consent

SV

SV


inclusion/exclusion

criteria

IC

SV


informed consent

SV


informed consent

SV


informed consent

SV


informed consent

IC


informed consent

IC

SV/Run-In


informed consent

SV

SV/Run-In


informed consent

SV


informed consent

SV

18/Mar/2013 Subject did not meet

inclusion/exclusion

criteria

SV


informed consent

SV

SV


informed consent

IC


informed consent

SV

IC

SV

SV

SV/Run-In


informed consent

SV


informed consent

IC


11/28


informed consent

IC


informed consent

IC


informed consent

IC

SV

SV

SV/Run-In

SV/Run-In

SV/Run-In

24/Mar/2013 50007 TV1

25/Mar/2013 50021 TV1.1

24/Mar/2013 50008 TV6

24/Mar/2013 50017 TV6

IC

24/Mar/2013 50018 TV3

24/Mar/2013 50019 TV3

25/Mar/2013 50020 TV2.1

25/Mar/2013 50022 TV6

25/Mar/2013 50023 TV6

27/Mar/2013 SV/Run-In


informed consent

SV/Run-In

SV

28/Mar/2013 Subject developed


SV



SV

SV

IC

IC


12/28

IC

IC

IC

SV

11/Apr/2013 Subject withdrew written

informed consent

IC

01/May/2013 IC

IC



IC


informed consent

SV

29/Jan/2013 Subject developedRespiratory Infection SV




SV/Run-In



SV

04/Feb/2013 50013 TV1


inclusion/exclusion

criteria

SV



SV/Run-In



inclusion/exclusion

criteria

SV/Run-In




21/Mar/2013 50014 TV4


inclusion/exclusion

criteria

SV/Run-In


informed consent

SV


13/28


inclusion/exclusion

criteria

SV



SV


informed consent

SV/Run-In

SV

SV

03/Feb/2013 50009 TV2


informed consent

SV/Run-In



SV

05/Feb/2013 IC


inclusion/exclusion

criteria

SV


informed consent

IC


inclusion/exclusion

criteria

IC


inclusion/exclusion

criteria

SV



informed consent

SV/Run-In


inclusion/exclusion

criteria

SV/Run-In



SV


informed consent

SV


informed consent

IC

22/Nov/2012 50010 TV6


informed consent

SV

27/Mar/2013 50011 TV6

27/Mar/2013 50012 TV1.1


14/28

27/Mar/2013 SV/Run-In



SV

27/Mar/2013 50026 TV1

27/Mar/2013 50025 TV3

27/Mar/2013 Subject did not meet

inclusion/exclusion

criteria

SV


informed consent

IC



SV



SV


informed consent

SV/Run-In



04/Feb/2013 IC


informed consent

IC


informed consent

SV


inclusion/exclusion

criteria

SV/Run-In



SV


SV

IC


15/28

Week1VisitDate(T

V2)

Week3VisitDate(TV3) Week6VisitDate

(TV4)

Week9VisitDate (TV5)


16/28

31/Jan/2013 31/Jan/2013 31/Jan/2013 31/Jan/2013

17/Jan/2013

22/Mar/2013


17/28


18/28

24/Mar/2013 24/Mar/2013 24/Mar/2013 24/Mar/2013

24/Mar/2013 24/Mar/2013 24/Mar/2013 24/Mar/2013

24/Mar/2013 24/Mar/2013

24/Mar/2013 24/Mar/2013

25/Mar/2013

25/Mar/2013 25/Mar/2013 25/Mar/2013 25/Mar/2013

25/Mar/2013 25/Mar/2013 25/Mar/2013 25/Mar/2013


19/28

21/Mar/2013 21/Mar/2013 21/Mar/2013


20/28

12/Feb/2013

24/Jan/2013 12/Feb/2013 12/Feb/2013 12/Feb/2013

27/Mar/2013 27/Mar/2013 27/Mar/2013 27/Mar/2013


21/28

27/Mar/2013 27/Mar/2013


22/28

Week12VisitDate

(TV6/EOT)

Early Withdrawal Date Unblinded

Date


23/28

31/Jan/2013 31/Jan/2013

21/Feb/2013


24/28


25/28

25/Mar/2013

24/Mar/2013

24/Mar/2013

24/Mar/2013

24/Mar/2013

25/Mar/2013

25/Mar/2013

25/Mar/2013


26/28


27/28

12/Feb/2013

27/Mar/2013


28/28

27/Mar/2013

abs as 301 blindedpatientdetailreport 05 jun 2013

Documents