-
Program: sdl_teae, 19:16 Page 177 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
05JAN2007/78111JAN2007/787
8 7 nomoderate
no possible dosenotchanged
recovered/resolved11JAN2007
Infections andinfestations/Vulvovaginalcandidiasis/VAGINAL THRUSH
21DEC2004/3625FEB2005/102
8 67 nomild
no notrelated
dosenotchanged
recovered/resolved25FEB2005
Musculoskeletal andconnective tissuedisorders/Arthritis/PAINFUL SWOLLENINFLAMED L)FOOT - ARTHRITIS
06APR2005/14212APR2005/148
8 7 nomoderate
no notrelated
dosenotchanged
recovered/resolved12APR2005
SP738/11159/female/25/caucasian/43.00
DB Gastrointestinaldisorders/Abdominal pain/ACUTE ABDOMINAL PAIN
01SEP2004/605SEP2004/10
4 5 yes[6]moderate
no notrelated
dosenotchanged
recovered/resolved05SEP2004
-
Program: sdl_teae, 19:16 Page 178 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Gastroenteritis/GASTRO-ENTERITIS
21OCT2004/5623OCT2004/58
4 3 nomild
no notrelated
dosenotchanged
recovered/resolved23OCT2004
OL Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
01DEC2005/46210APR2006/592
4 131 nomild
no notrelated
dosenotchanged
recovered/resolved10APR2006
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
20NOV2006/81627NOV2006/823
4 8 nomild
no notrelated
dosenotchanged
recovered/resolved27NOV2006
SP738/11160/female/56/caucasian/79.00
OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
--NOV2004/1--APR2005/163
8 163 nomoderate
no highlyprobable
dosenotchanged
recovered/resolved30APR2005
Gastrointestinaldisorders/Dry mouth/DRY MOUTH WORSENING
30APR2005/16321JUL2005/245
8 83 nosevere
no highlyprobable
dosereduced
recovered/resolved21JUL2005
-
Program: sdl_teae, 19:16 Page 179 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Immune systemdisorders/Seasonal allergy/POLLINOSIS
06APR2007/+3Ongoing
0 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Infections andinfestations/Cystitis/CYSTITIS
29DEC2004/4104JAN2005/47
8 7 nosevere
no possible dosenotchanged
recovered/resolved04JAN2005
Infections andinfestations/Cystitis/CYSTITIS
19OCT2005/33525OCT2005/341
4 7 nomoderate
no unlikely dosenotchanged
recovered/resolved25OCT2005
Infections andinfestations/Cystitis/CYSTITIS
31OCT2006/71204NOV2006/716
4 5 nomoderate
no unlikely dosenotchanged
recovered/resolved04NOV2006
Infections andinfestations/Cystitis/CYSTITIS
24JAN2007/79731JAN2007/804
4 8 nomoderate
no notrelated
dosenotchanged
recovered/resolved31JAN2007
Infections andinfestations/Influenza/FLU
03FEB2005/7710FEB2005/84
8 8 nosevere
no notrelated
dosenotchanged
recovered/resolved10FEB2005
-
Program: sdl_teae, 19:16 Page 180 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Injury, poisoning andproceduralcomplications/Hand fracture/BROKEN LITTLE FINGERRIGHT HAND
23AUG2006/64301FEB2007/805
4 163 nomoderate
no notrelated
dosenotchanged
recovered/resolved01FEB2007
Musculoskeletal andconnective tissuedisorders/Neck pain/NECK PAIN
09DEC2004/2109DEC2004/21
8 1 nomoderate
no notrelated
dosenotchanged
recovered/resolved09DEC2004
Renal and urinarydisorders/Stress urinaryincontinence/STRESSINCONTINENCE(->TVT.O PROCEDURETRANSVAGINAL TAPE
13JUL2006/60220OCT2006/701
4 100 yes[6]moderate
no notrelated
dosenotchanged
recovered/resolved20OCT2006
SP738/11165/female/62/caucasian/80.00
DB Gastrointestinaldisorders/Nausea/NAUSEA
17SEP2004/1720SEP2004/20
8 4 nomoderate
no unlikely dosenotchanged
recovered/resolved20SEP2004
Gastrointestinaldisorders/Vomiting/VOMITING
17SEP2004/1720SEP2004/20
8 4 nomoderate
no unlikely dosenotchanged
recovered/resolved20SEP2004
-
Program: sdl_teae, 19:16 Page 181 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Alanineaminotransferaseincreased/INCREASED ALT
28SEP2004/2826OCT2004/56
8 29 nomild
no unlikely dosenotchanged
recovered/resolved26OCT2004
Investigations/Blood alkalinephosphataseincreased/INCREASED ALKALINEPHOSPHATASE
28SEP2004/2826OCT2004/56
8 29 nomild
no unlikely dosenotchanged
recovered/resolved26OCT2004
Investigations/Blood glucoseincreased/INCREASED GLUCOSE
28SEP2004/2826OCT2004/56
8 29 nomild
no unlikely dosenotchanged
recovered/resolved26OCT2004
Investigations/Gamma-glutamyltransferase increased/INCREASED GGT
28SEP2004/2826OCT2004/56
8 29 nomild
no unlikely dosenotchanged
recovered/resolved26OCT2004
OL Gastrointestinaldisorders/Diarrhoea/DIARRHOEA
19SEP2006/74901JAN2007/853
8 105 nomild
no unlikely dosenotchanged
recovered/resolved01JAN2007
Gastrointestinaldisorders/Vomiting/VOMITING
10JAN2005/13210JAN2005/132
8 1 nomild
no notrelated
dosenotchanged
recovered/resolved10JAN2005
-
Program: sdl_teae, 19:16 Page 182 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Gastrointestinaldisorders/Vomiting/VOMITTING
18SEP2006/74810MAR2007/921
8 174 nomild
no possible dosenotchanged
recovered/resolved10MAR2007
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
18MAR2005/19904APR2005/216
8 18 nomild
no notrelated
dosenotchanged
recovered/resolved04APR2005
Investigations/Arthroscopy/LEFT KNEE ARTHROSCOPY
20FEB2007/90320FEB2007/903
8 1 yes[6]severe
no notrelated
dosenotchanged
recovered/resolved20FEB2007
Investigations/Blood glucoseincreased/ELEVATED BLOODGLUCOSE LEVEL
02DEC2005/458Ongoing
8 nomild
no unlikely dosenotchanged
notrecovered/notresolved
DB/OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
01SEP2004/1Ongoing
8 nomild
no probable dosenotchanged
notrecovered/notresolved
Infections andinfestations/Pertussis/WHOOPING COUGH
16SEP2004/1601FEB2005/154
8 139 nomoderate
no notrelated
dosenotchanged
recovered/resolved01FEB2005
-
Program: sdl_teae, 19:16 Page 183 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Blood glucoseincreased/ELEVATED GLUCOSE
26NOV2004/8718MAR2005/199
8 113 nomild
no notrelated
dosenotchanged
recovered/resolved18MAR2005
SP738/11167/female/56/caucasian/70.00
DB Infections andinfestations/Influenza/FLU
05OCT2004/3508OCT2004/38
4 4 nomild
no notrelated
dosenotchanged
recovered/resolved08OCT2004
OL Gastrointestinaldisorders/Hiatus hernia/HIATUS HERNIA
30JUL2006/69821SEP2006/751
8 54 yes[6]severe
no notrelated
dosenotchanged
recovered/resolved21SEP2006
Infections andinfestations/Bronchitis/BRONCHITIS
16FEB2006/53431MAR2006/577
8 44 nomild
no notrelated
dosenotchanged
recovered/resolved31MAR2006
SP738/11169/female/61/caucasian/59.00
OL Cardiac disorders/Myocardialinfarction/MYOCARDIAL INFARCT
19AUG2005/25528SEP2005/295
8 41 yes[6]severe
no unlikely dosenotchanged
recovered/resolved28SEP2005
-
Program: sdl_teae, 19:16 Page 184 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Gastrointestinaldisorders/Dry mouth/DRY MOUTH
04JAN2005/28Ongoing
8 nomild
no possible dosenotchanged
notrecovered/notresolved
Gastrointestinaldisorders/Gastric disorder/STOMACH DISORDER
02AUG2005/238Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Hepatobiliarydisorders/Hepatic steatosis/LIVER STEATOSE
28JUL2006/598Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Investigations/Gamma-glutamyltransferase increased/GAMMA GT ELEVATION
11JUL2006/581Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Metabolism andnutrition disorders/Hypercholesterolaemia/HYPERCHOLESTEROLEMIA
02AUG2005/238Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Metabolism andnutrition disorders/Obesity/OBESITAS DUE TO STOPSMOKING
28JUL2006/598Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
-
Program: sdl_teae, 19:16 Page 185 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Psychiatricdisorders/Anxiety/ANXIETY
02AUG2005/238Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Reproductive systemand breast disorders/Breast tenderness/BREAST TENDERNESS
04MAY2005/14805MAY2005/149
8 2 nomild
no notrelated
dosenotchanged
recovered/resolved05MAY2005
Vascular disorders/Hypertension/ARTERIAL HYPERTENSION
02AUG2005/238Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
SP738/11179/female/35/caucasian/55.00
OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
26NOV2004/1Ongoing
8 nomoderate
no highlyprobable
dosereduced
Lost tofollow-up
Respiratory, thoracicand mediastinaldisorders/Pneumothorax/PNEUMOTHORAX
--DEC2004/607FEB2005/74
8 69 yes[6]severe
no notrelated
dosenotchanged
recovered/resolvedwithsequelae07FEB2005
-
Program: sdl_teae, 19:16 Page 186 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
SP738/11184/female/68/caucasian/81.00
OL General disorders andadministration siteconditions/Sudden death/SUDDEN DEATH
01AUG2005/33301AUG2005/333
4 1 yes[1]severe
yes unlikely notapplicable
fatal01AUG2005
DB/OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
06SEP2004/4Ongoing
8 nomoderate
no highlyprobable
dosenotchanged
notrecovered/notresolved
Gastrointestinaldisorders/Dyspepsia/DYSPEPSIA
05SEP2004/3Ongoing
8 nomoderate
no highlyprobable
dosenotchanged
notrecovered/notresolved
SP738/11185/female/68/caucasian/63.10
DB Infections andinfestations/Cystitis/BLADDER INFECTION
28SEP2004/2505OCT2004/32
8 8 nomild
no notrelated
dosenotchanged
recovered/resolved05OCT2004
-
Program: sdl_teae, 19:16 Page 187 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Residual urinevolume/RESIDUAL URINE VOLUMEABOVE 200 ML (RESULTOF AN INVESTIGATIONON 20/09/04)
20SEP2004/1716NOV2004/74
8 58 nomild
no possible dosenotchanged
recovered/resolved16NOV2004
OL Gastrointestinaldisorders/Abdominal pain/ABDOMINAL PAIN
16DEC2004/+23Ongoing
0 nomoderate
no notrelated
notapplicable
Lost tofollow-up
-
Program: sdl_teae, 19:16 Page 188 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
Program: sdl_teae, 19:16 Page 188 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Residual urinevolume/RESIDUAL VOLUME ABOVE200 ML
29NOV2004/+629NOV2004/+6
0 1 nomild
yes possible drugwithdrawn
recovered/resolved29NOV2004
Musculoskeletal andconnective tissuedisorders/Pain in extremity/PAIN LOWER LEGS
16DEC2004/+23Ongoing
0 nomild
no notrelated
notapplicable
Lost tofollow-up
DB/OL Eye disorders/Visual acuityreduced/REDUCED VISION
02OCT2004/2929NOV2004/+6
8 59 nomild
no possible dosenotchanged
recovered/resolved29NOV2004
Gastrointestinaldisorders/Abdominal discomfort/ABDOMINAL DISCOMFORT
02OCT2004/2929NOV2004/+6
8 59 nomoderate
no possible dosenotchanged
recovered/resolved29NOV2004
General disorders andadministration siteconditions/Discomfort/GENERAL DISCOMFORT
02OCT2004/29Ongoing
8 nomoderate
no possible dosenotchanged
notrecovered/notresolved
Metabolism andnutrition disorders/Decreased appetite/REDUCED APPETITE
02OCT2004/2929NOV2004/+6
8 59 nomild
no possible dosenotchanged
recovered/resolved29NOV2004
-
Program: sdl_teae, 19:16 Page 189 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Nervous systemdisorders/Sciatica/PSEUDO ISCHIALGIA (=LUMBARISCHIALGIA = PAIN ONHIP)
02OCT2004/29Ongoing
8 yes[6]moderate
no unlikely dosenotchanged
notrecovered/notresolved
Vascular disorders/Varicose vein/VARICES ON LEGS
16NOV2004/74Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
SP738/11211/male/60/caucasian/79.40
OL Eye disorders/Conjunctivitis/CONJUNCTIVITIS LEFTEYE
10AUG2006/60117AUG2006/608
8 8 nomoderate
no unlikely dosenotchanged
recovered/resolved17AUG2006
Gastrointestinaldisorders/Dysphagia/DYSPHAGIA
--FEB2005/46Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Gastrointestinaldisorders/Nausea/NAUSEA
15AUG2005/24115AUG2005/241
8 1 nomild
no dosenotchanged
recovered/resolved15AUG2005
-
Program: sdl_teae, 19:16 Page 190 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Gastrointestinaldisorders/Oesophagitis/MODERATELY SEVEREGRADE II(SAVERY-MILLER)OESOPHAGITIS.
17JAN2006/396Ongoing
8 nomoderate
no unlikely dosenotchanged
notrecovered/notresolved
General disorders andadministration siteconditions/Pain/PAIN UNDER RIBS
14SEP2006/63621SEP2006/643
8 8 nomild
no unlikely dosenotchanged
recovered/resolved21SEP2006
Investigations/Blood glucoseincreased/RAISED GLUCOSE.
16AUG2005/24210OCT2005/297
8 56 nomild
no unlikely dosenotchanged
recovered/resolved10OCT2005
Investigations/Blood triglyceridesincreased/RAISED TRIGLYCERIDES
17AUG2006/608Ongoing
8 nomoderate
no notrelated
dosenotchanged
notrecovered/notresolved
Investigations/Lymphocyte countincreased/RAISED LYMPHOCYTES
16AUG2005/24216DEC2005/364
8 123 nomild
no unlikely dosenotchanged
recovered/resolved16DEC2005
Investigations/Neutrophil countincreased/RAISED NEUTROPHILS
16AUG2005/24216DEC2005/364
8 123 nomild
no unlikely dosenotchanged
recovered/resolved16DEC2005
-
Program: sdl_teae, 19:16 Page 191 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Neutrophil countincreased/RAISED NEUTROPHILS.ABS
16AUG2005/24216DEC2005/364
8 123 nomild
no unlikely dosenotchanged
recovered/resolved16DEC2005
Investigations/Neutrophil percentageincreased/RAISED NEUTROPHILSEGS
16AUG2005/24216DEC2005/364
8 123 nomild
no unlikely dosenotchanged
recovered/resolved16DEC2005
Investigations/Neutrophil percentageincreased/RAISED NEUTROPHILS.SEGS. ABS
16AUG2005/24216DEC2005/364
8 123 nomild
no unlikely dosenotchanged
recovered/resolved16DEC2005
Investigations/White blood cellcount increased/INCREASED WHITE BLOODCOUNT
12AUG2005/23815AUG2005/241
8 4 nomoderate
no unlikely druginterrupted
recovered/resolved15AUG2005
Musculoskeletal andconnective tissuedisorders/Pain in extremity/GENERALISED ACHES INLEFT ARM
19JUN2006/549--JUL2006/591
8 43 nomild
no notrelated
dosenotchanged
recovered/resolved31JUL2006
-
Program: sdl_teae, 19:16 Page 192 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Nervous systemdisorders/Dizziness/DIZZINESS
19JUN2006/54923JUN2006/553
8 5 nomild
no unlikely dosenotchanged
recovered/resolved23JUN2006
Nervous systemdisorders/Dysarthria/SLURRED SPEECH
12AUG2005/23823AUG2005/249
8 12 yes[6]moderate
no unlikely druginterrupted
recovered/resolved23AUG2005
Nervous systemdisorders/Loss ofconsciousness/BLACKOUTS
06JUN2005/17123AUG2005/249
8 79 nomild
no unlikely dosenotchanged
recovered/resolved23AUG2005
Nervous systemdisorders/Migraine/MIGRAINE WORSENED
12AUG2005/238Ongoing
8 nomild
no unlikely druginterrupted
notrecovered/notresolved
Nervous systemdisorders/Sensory loss/LOSS OF SENSATION TWOFINGERS OF LEFT HAND
19JUN2006/549--JUL2006/591
8 43 nomild
no notrelated
dosenotchanged
recovered/resolved31JUL2006
Psychiatricdisorders/Disorientation/DISORIENTATION
12AUG2005/23823AUG2005/249
8 12 yes[6]moderate
no unlikely druginterrupted
recovered/resolved23AUG2005
-
Program: sdl_teae, 19:16 Page 193 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Reproductive systemand breast disorders/Erectile dysfunction/ERECTILE DYSFUNCTIONWORSENED
--NOV2005/319Ongoing
8 nomoderate
no unlikely dosenotchanged
notrecovered/notresolved
Respiratory, thoracicand mediastinaldisorders/Asthma/INFECTIVEEXACERBATION OFASTHMA.
--MAY2005/135Ongoing
8 nomoderate
no unlikely dosenotchanged
recovering/resolving
Skin and subcutaneoustissue disorders/Rash/RASH IN GROIN
--OCT2006/653--DEC2006/744
8 92 nomoderate
no unlikely dosenotchanged
recovered/resolved31DEC2006
Vascular disorders/Circulatory collapse/COLLAPSE
12AUG2005/23823AUG2005/249
8 12 yes[6]moderate
no unlikely druginterrupted
recovered/resolved23AUG2005
SP738/11225/female/47/caucasian/78.10
OL Blood and lymphaticsystem disorders/Anaemia/ANEMIA
09JUN2006/549Ongoing
8 nomild
no unlikely dosenotchanged
notrecovered/notresolved
-
Program: sdl_teae, 19:16 Page 194 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Cardiac disorders/Cardiac failure/SUSPECTED HEARTFAILURE
09JUN2006/54930JUN2006/570
8 22 nomoderate
no unlikely dosenotchanged
recovered/resolved30JUN2006
Gastrointestinaldisorders/Dry mouth/MOUTH DRYNESS
08DEC2004/108APR2005/122
8 122 nomild
no probable dosenotchanged
recovered/resolved08APR2005
Gastrointestinaldisorders/Gastrooesophagealreflux disease/PLANNED SURGERY FORGASTROOESOPHAGEALREFLUX
28AUG2006/62929AUG2006/630
8 2 yes[6]moderate
no notrelated
dosenotchanged
recovered/resolved29AUG2006
Investigations/Hepatic enzymeincreased/HEIGHTENED LIVERENZYMES
10APR2006/48908AUG2006/609
8 121 nomild
no unlikely dosenotchanged
recovered/resolved08AUG2006
Metabolism andnutrition disorders/Hypercholesterolaemia/HYPERCHOLESTEROLEMIA
--APR2006/480Ongoing
8 nomoderate
no unlikely dosenotchanged
notrecovered/notresolved
-
Program: sdl_teae, 19:16 Page 195 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Neoplasms benign,malignant andunspecified (inclcysts and polyps)/Uterine leiomyoma/MYOMA UTERI
14DEC2006/737Ongoing
8 nomild
no unlikely dosenotchanged
notrecovered/notresolved
Nervous systemdisorders/Carpal tunnelsyndrome/OPERATION DUE TOCARPAL TUNNEL SYNDROMRIGHT HAND
10MAR2005/9310MAR2005/93
8 1 nomoderate
no notrelated
dosenotchanged
recovered/resolved10MAR2005
Reproductive systemand breast disorders/Menorrhagia/PROFUSE MENSTRUATION
--JAN2007/755Ongoing
8 nomoderate
no unlikely dosenotchanged
notrecovered/notresolved
SP738/11231/female/67/caucasian/71.50
OL Gastrointestinaldisorders/Abdominal pain upper/STOMACH PAIN
18DEC2004/203JAN2005/18
8 17 nomild
no unlikely dosenotchanged
recovered/resolved03JAN2005
Gastrointestinaldisorders/Change of bowelhabit/ALTERED BOWEL HABIT
11SEP2006/634Ongoing
8 nomild
no possible dosenotchanged
notrecovered/notresolved
-
Program: sdl_teae, 19:16 Page 196 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Gastrointestinaldisorders/Diarrhoea/DIARRHOEA
19JUL2005/21521JUL2005/217
8 3 nomild
no unlikely dosenotchanged
recovered/resolved21JUL2005
Gastrointestinaldisorders/Diarrhoea/DIARRHOEA
24NOV2005/34301DEC2005/350
8 8 nomild
no unlikely dosenotchanged
recovered/resolved01DEC2005
Gastrointestinaldisorders/Diarrhoea/LOOSE STOOLS
20DEC2004/421DEC2004/5
8 2 nomoderate
no unlikely dosenotchanged
recovered/resolved21DEC2004
Gastrointestinaldisorders/Flatulence/FLATULENCE
20DEC2004/421DEC2004/5
8 2 nomoderate
no unlikely dosenotchanged
recovered/resolved21DEC2004
Gastrointestinaldisorders/Nausea/NAUSEA
19DEC2004/320DEC2004/4
8 2 nomild
no unlikely dosenotchanged
recovered/resolved20DEC2004
Infections andinfestations/Diverticulitis/DIVERTICULITIS
10NOV2005/32915NOV2005/334
8 6 nomild
no unlikely dosenotchanged
recovered/resolved15NOV2005
-
Program: sdl_teae, 19:16 Page 197 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Influenza/FLU
11SEP2006/63420SEP2006/643
8 10 nomoderate
no unlikely dosenotchanged
recovered/resolved20SEP2006
Infections andinfestations/Nasopharyngitis/COLD
14MAR2005/8817MAR2005/91
8 4 nomild
no unlikely dosenotchanged
recovered/resolved17MAR2005
Infections andinfestations/Nasopharyngitis/COLD
07JUN2005/17321JUN2005/187
8 15 nomoderate
no unlikely dosenotchanged
recovered/resolved21JUN2005
Infections andinfestations/Nasopharyngitis/COLD
--DEC2005/35015DEC2005/364
8 15 nomild
no unlikely dosenotchanged
recovered/resolved15DEC2005
Infections andinfestations/Nasopharyngitis/COLD
02NOV2006/68604NOV2006/688
8 3 nomild
no unlikely dosenotchanged
recovered/resolved04NOV2006
Infections andinfestations/Nasopharyngitis/COLD
04DEC2006/71810DEC2006/724
8 7 nomoderate
no unlikely dosenotchanged
recovered/resolved10DEC2006
-
Program: sdl_teae, 19:16 Page 198 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Urinary tractinfection/? URINARY TRACTINFECTION
14DEC2006/72819DEC2006/733
8 6 nomoderate
no possible dosenotchanged
recovered/resolved19DEC2006
Musculoskeletal andconnective tissuedisorders/Arthralgia/HIP PAIN
02AUG2005/22902AUG2005/229
8 1 nomild
no unlikely dosenotchanged
recovered/resolved02AUG2005
Musculoskeletal andconnective tissuedisorders/Foot deformity/RIGHT HALLUX VALGUS
10JUL2006/57120SEP2006/643
8 73 yes[6]moderate
no notrelated
dosenotchanged
recovered/resolved20SEP2006
Respiratory, thoracicand mediastinaldisorders/Cough/COUGH
10MAR2006/44924MAR2006/463
8 15 nomoderate
no notrelated
dosenotchanged
recovered/resolved24MAR2006
Skin and subcutaneoustissue disorders/Rash/FACIAL RASH
13FEB2005/5913APR2005/118
8 60 nomild
no unlikely dosenotchanged
recovered/resolved13APR2005
-
Program: sdl_teae, 19:16 Page 199 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Surgical and medicalprocedures/Hip arthroplasty/LEFT TOTAL HIPREPLACEMENT
19FEB2007/79528FEB2007/804
8 10 yes[6]severe
no notrelated
dosenotchanged
recovered/resolvedwithsequelae28FEB2007
SP738/11237/female/68/caucasian/68.50
OL Endocrine disorders/Goitre/ENLARGED THYROID
--NOV2005/31901MAR2007/804
4 486 yes[6]moderate
no possible dosenotchanged
recovered/resolved01MAR2007
Gastrointestinaldisorders/Gastrooesophagealreflux disease/GASTRO-OSOPHAGEALREFLUX "HEARTBURN"
--JUN2006/531Ongoing
4 nomild
no possible dosenotchanged
notrecovered/notresolved
General disorders andadministration siteconditions/Cyst/CYST ON KNEE
27JUL2006/58724OCT2006/676
4 90 nomild
no possible dosenotchanged
recovered/resolved24OCT2006
Musculoskeletal andconnective tissuedisorders/Intervertebral discdegeneration/DISC DESICCATION
--JAN2005/15--OCT2006/683
8 669 nosevere
no notrelated
dosenotchanged
recovered/resolved31OCT2006
-
Program: sdl_teae, 19:16 Page 200 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
THROUGHOUT THORACICAND LUMBOSACRALREGIONS
Musculoskeletal andconnective tissuedisorders/Rheumatoid arthritis/(L) ANKLE PAIN DUE TOQUERY RHEUMATOIDARTHRITIS.
07SEP2005/26424OCT2006/676
4 413 nosevere
no unlikely dosenotchanged
recovered/resolved24OCT2006
Nervous systemdisorders/Nerve rootcompression/L4 ROOT COMPRESSION
28APR2005/13204MAY2005/138
4 7 yes[6]severe
no notrelated
dosenotchanged
recovered/resolved04MAY2005
SP738/11241/female/63/asian/67.00
OL Infections andinfestations/Influenza/INFLUENZA
03MAY2005/22910MAY2005/236
8 8 nomild
no notrelated
dosenotchanged
recovered/resolved10MAY2005
-
Program: sdl_teae, 19:16 Page 201 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Musculoskeletal andconnective tissuedisorders/Arthralgia/PAINFUL HIP - RIGHT
12FEB2006/51412APR2006/573
8 60 nomild
no unlikely dosenotchanged
recovered/resolved12APR2006
Musculoskeletal andconnective tissuedisorders/Gouty tophus/GOUTY TOPHUS
24MAY2006/61514AUG2006/697
8 83 yes[6]mild
no notrelated
dosenotchanged
recovered/resolved14AUG2006
Renal and urinarydisorders/Dysuria/VOIDING DIFFICULTY
07MAR2006/53714MAR2006/544
8 8 nomild
no highlyprobable
dosenotchanged
recovered/resolved14MAR2006
SP738/11249/male/67/caucasian/83.00
DB Cardiac disorders/Sinus arrhythmia/CARDIAC ARRYTHMIA(SINUS ARRHYTMIA)
14OCT2004/2811NOV2004/56
8 29 nomoderate
no unlikely dosenotchanged
recovered/resolved11NOV2004
Injury, poisoning andproceduralcomplications/Procedural pain/POSTOPERATIVE PAIN
05OCT2004/1909OCT2004/23
8 5 nomild
no notrelated
dosenotchanged
recovered/resolved09OCT2004
-
Program: sdl_teae, 19:16 Page 202 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Investigations/Arthroscopy/ARTHROSCOPY OFSHOULDER JOINT
05OCT2004/1905OCT2004/19
8 1 nomild
no notrelated
dosenotchanged
recovered/resolved05OCT2004
OL Cardiac disorders/Myocardialinfarction/MYOCARDIAL INFARCTION
14JAN2006/48519JAN2006/+5
4 6 yes[6]severe
yes notrelated
drugwithdrawn
recovered/resolved19JAN2006
Gastrointestinaldisorders/Dry mouth/DRYNESS IN MOUTH
--FEB2005/13814JAN2006/485
8 348 nomild
no highlyprobable
dosenotchanged
recovered/resolved14JAN2006
Gastrointestinaldisorders/Umbilical hernia/UMBILICAL HERNIA
--AUG2005/319Ongoing
8 nomild
no notrelated
dosenotchanged
notrecovered/notresolved
Renal and urinarydisorders/Nocturia/NOCTURNAL POLYURIA
--AUG2005/319--AUG2005/349
8 31 nomild
no unlikely dosenotchanged
recovered/resolved31AUG2005
Reproductive systemand breast disorders/Erectile dysfunction/SLIGHT ERECTILEDYSFUNCTION
--APR2005/197Ongoing
8 nomild
no possible dosenotchanged
notrecovered/notresolved
-
Program: sdl_teae, 19:16 Page 203 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
SP738/11252/male/70/caucasian/77.00
DB Cardiac disorders/Sinus arrhythmia/CARDIAC ARRHYTMIA(SINUS ARRYTHMIA)
14OCT2004/2811NOV2004/56
4 29 nomoderate
no unlikely dosenotchanged
recovered/resolved11NOV2004
OL Cardiac disorders/Angina pectoris/ANGINA PECTORIS
05APR2006/56617MAY2006/608
8 43 yes[6]severe
no unlikely dosenotchanged
recovered/resolved17MAY2006
Gastrointestinaldisorders/Dry mouth/DRYNESS IN MOUTH
--FEB2005/13811APR2007/937
8 800 nomild
no highlyprobable
dosenotchanged
recovered/resolved11APR2007
Musculoskeletal andconnective tissuedisorders/Musculoskeletal pain/SHOULDER PAIN
03MAR2005/16810MAR2005/175
8 8 nomoderate
no notrelated
dosenotchanged
recovered/resolved10MAR2005
SP738/11259/female/79/caucasian/73.00
OL Infections andinfestations/Diverticulitis/DIVERTICULITISWORSENED
21MAY2005/16921MAY2005/169
8 1 yes[6]severe
no notrelated
druginterrupted
recovered/resolved21MAY2005
-
Program: sdl_teae, 19:16 Page 204 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
12APR2006/49516APR2006/499
8 5 nomild
no notrelated
dosenotchanged
recovered/resolved16APR2006
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
30MAR2007/84707APR2007/+3
8 9 nomoderate
no notrelated
dosenotchanged
recovered/resolved07APR2007
Injury, poisoning andproceduralcomplications/Meniscus lesion/RIGHT KNEE, MENISCALTEAR OF MEDIAL HORN
17MAY2005/16517MAY2005/165
8 1 yes[6]moderate
no notrelated
druginterrupted
recovered/resolved17MAY2005
Musculoskeletal andconnective tissuedisorders/Rotator cuffsyndrome/RIGHT SHOULDER,PARTIAL TEAR OFROTATOR CUFF
17MAY2005/16517MAY2005/165
8 1 yes[6]moderate
no notrelated
druginterrupted
recovered/resolved17MAY2005
-
Program: sdl_teae, 19:16 Page 205 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Musculoskeletal andconnective tissuedisorders/Tendonitis/TENDONITIS RIGHTSHOULDER
20MAR2005/10717MAY2005/165
8 59 nomoderate
no notrelated
dosenotchanged
recovered/resolved17MAY2005
SP738/11262/female/57/caucasian/105.00
OL Cardiac disorders/Myocardialinfarction/MYOCARDIAL INFARCTION
17SEP2005/27716DEC2005/367
8 91 yes[6]moderate
no unlikely dosenotchanged
recovered/resolved16DEC2005
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
23MAR2005/9927APR2005/134
8 36 nomoderate
no unlikely dosenotchanged
recovered/resolved27APR2005
Nervous systemdisorders/Epilepsy/EPILEPTIC SEIZURE
01MAY2005/13814MAY2005/151
8 14 nosevere
no notrelated
dosenotchanged
recovered/resolved14MAY2005
-
Program: sdl_teae, 19:16 Page 206 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
SP738/11277/female/81/caucasian/92.00
OL Infections andinfestations/Cellulitis/CELLULITIS
29DEC2004/1412JAN2005/28
8 15 nomoderate
no unlikely dosenotchanged
recovered/resolved12JAN2005
Respiratory, thoracicand mediastinaldisorders/Diaphragmatic hernia/DIAPHRAGMATIC HERNIA
09MAR2005/8413MAR2005/88
8 5 yes[6]moderate
no unlikely dosenotchanged
recovered/resolved13MAR2005
SP738/11291/female/65/caucasian/70.00
DB Metabolism andnutrition disorders/Hypokalaemia/HYPOKALEMIA
08OCT2004/1619NOV2004/58
4 43 nomoderate
no notrelated
dosenotchanged
recovered/resolved19NOV2004
OL Infections andinfestations/Liver abscess/LIVER ABSCESS
10FEB2005/14120MAR2005/179
8 39 yes[6]severe
no notrelated
dosenotchanged
recovered/resolved20MAR2005
Infections andinfestations/Otitis externa/OTITIS EXTERNA
13APR2005/20315APR2005/205
8 3 nomild
no notrelated
dosenotchanged
recovered/resolved15APR2005
-
Program: sdl_teae, 19:16 Page 207 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Metabolism andnutrition disorders/Hypokalaemia/HYPOKALEMIA
15APR2005/205Ongoing
8 nomoderate
no notrelated
dosenotchanged
notrecovered/notresolved
Renal and urinarydisorders/Urinary incontinence/URINARY INCONTINENCE
01DEC2005/435Ongoing
8 nomoderate
no notrelated
drugwithdrawn
notrecovered/notresolved
Renal and urinarydisorders/Urinary retention/URINARY RETENTION
30NOV2005/43430NOV2005/434
8 1 yes[6]severe
yes highlyprobable
drugwithdrawn
recovered/resolvedwithsequelae30NOV2005
DB/OL Infections andinfestations/Pharyngitis/PHARYNGITIS
16DEC2004/8520DEC2004/89
4 5 nomild
no notrelated
dosenotchanged
recovered/resolved20DEC2004
SP738/11311/female/69/caucasian/65.00
OL Gastrointestinaldisorders/Spigelian hernia/SPIGELIAN HERNIA
04MAY2006/49714MAY2006/507
4 11 yes[6]severe
no unlikely dosenotchanged
recovered/resolved14MAY2006
Infections andinfestations/Bronchitis/BRONCHITIS
07APR2007/83516MAY2007/+28
4 40 nomoderate
no notrelated
dosenotchanged
recovered/resolved16MAY2007
-
Program: sdl_teae, 19:16 Page 208 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Gastroenteritis/GASTROENTERITIS
26DEC2004/327DEC2004/4
8 2 nomild
no notrelated
dosenotchanged
recovered/resolved27DEC2004
Vascular disorders/Hypotension/HYPOTENSION
02MAY2007/+14Ongoing
0 nomild
no notrelated
notapplicable
notrecovered/notresolved
SP738/11313/female/60/caucasian/65.20
OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
24DEC2004/213APR2007/+2
8 841 nomoderate
no probable dosereduced
recovered/resolved13APR2007
Musculoskeletal andconnective tissuedisorders/Arthritis/ARTHRITIS
27OCT2005/30928OCT2005/310
4 2 yes[6]moderate
no notrelated
dosenotchanged
recovered/resolved28OCT2005
Nervous systemdisorders/Dizziness/DIZZINESS -INTERMITTANT
21NOV2005/33405FEB2006/410
4 77 nomild
no possible dosenotchanged
recovered/resolved05FEB2006
-
Program: sdl_teae, 19:16 Page 209 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Psychiatricdisorders/Stress/PSYCHOLOGICALSTRESS - DUE TOSOCIAL CRISIS
21NOV2005/33431JAN2006/405
4 72 nomoderate
no notrelated
dosenotchanged
recovered/resolved31JAN2006
SP738/11329/female/60/caucasian/74.00
OL Renal and urinarydisorders/Stress urinaryincontinence/STRESS INCONTINENCE
21JAN2005/2409MAR2005/+9
8 48 yes[6]moderate
yes notrelated
drugwithdrawn
recovered/resolved09MAR2005
SP738/11336/female/39/caucasian/62.00
OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
30JAN2005/3115JAN2006/381
8 351 nomoderate
no probable dosereduced
recovered/resolvedwithsequelae15JAN2006
Gastrointestinaldisorders/Dry mouth/DRY MOUTH
16JAN2006/38230APR2007/+4
4 470 nomild
no possible dosenotchanged
recovered/resolved30APR2007
Infections andinfestations/Respiratory tractinfection/RESPIRATORY INFECTION
27AUG2005/24031AUG2005/244
8 5 nomild
no notrelated
dosenotchanged
recovered/resolved31AUG2005
-
Program: sdl_teae, 19:16 Page 210 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Infections andinfestations/Respiratory tractinfection/RESPIRATORY INFECTION
08DEC2005/34323DEC2005/358
8 16 nomoderate
no notrelated
dosenotchanged
recovered/resolved23DEC2005
Infections andinfestations/Respiratory tractinfection/RESPIRATORY TRACTINFECTION
09DEC2006/70916DEC2006/716
4 8 nomoderate
no notrelated
dosenotchanged
recovered/resolved16DEC2006
Neoplasms benign,malignant andunspecified (inclcysts and polyps)/Uterine leiomyoma/UTERUS MYOMATOSUS
16FEB2006/41320FEB2006/417
4 5 yes[6]moderate
no notrelated
druginterrupted
recovered/resolved20FEB2006
Psychiatricdisorders/Sleep disorder/SLEEP DISORDERS
08MAR2005/6815JAN2007/746
8 679 nomild
no unlikely dosereduced
recovered/resolved15JAN2007
SP738/11347/female/66/caucasian/80.00
OL Gastrointestinaldisorders/Dry mouth/DRY MOUTH
24DEC2004/1--MAY2007/+27
8 889 nomoderate
no probable dosenotchanged
recovered/resolved31MAY2007
-
Program: sdl_teae, 19:16 Page 211 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)
Listing 1Subjects with Serious TEAEs
Population: Pool_S3
AE OnsetAE Stop Trial Medication
AEOutcome
_________ _______________ ______
Trial/Subject/Gender/Age/Race/Wt(kg)
StudyPart
System Organ Class/Preferred Term/Reported Term
Date/Rel Day
Doseatonset(mg)
Dura-tion(days)
Serious[a]Intensity
Drop-outDuetoAE Relation
ActionTaken
ResultDate
Gastrointestinaldisorders/Gastrooesophagealreflux disease/GASTRIC REFLUX
01JAN2005/9Ongoing
8 nomoderate
no unlikely dosenotchanged
notrecovered/notresolved
Gastrointestinaldisorders/Ileus/PROLONGED ILEUS
16SEP2006/63218SEP2006/634
8 3 yes[6]severe
no notrelated
druginterrupted
recovered/resolved18SEP2006
Gastrointestinaldisorders/Vomiting/VOMITING
--DEC2005/343Ongoing
8 nomild
no possible dosenotchanged
notrecovered/notresolved
Infections andinfestations/Urinary tractinfection/URINARY TRACTINFECTION
--JAN2007/73906JUN2007/+33
8 157 nomoderate
no possible dosenotchanged
recovered/resolved06JUN2007
Injury, poisoning andproceduralcomplications/Ankle fracture/FRACTURED LEFT ANKLE
07MAR2006/439--SEP2006/646
8 208 nomoderate
no notrelated
dosenotchanged
recovered/resolved30SEP2006
-
Program: sdl_teae, 19:16 Page 212 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
Program: sdl_teae, 19:16 Page 212 of 314
Note: For subjects who participated in an open label trial, the trial number refers to their open label period. Otherwise, the double blindtrial number is referenced.
[a] Serious reason: 1=results in death, 2=life-threatening, 3=results in persistent or significant disability, 4=congenital anomaly/birthdefect, 5=important medical event, 6=requires in-patient hospitalization or prolongation of existing hospitalization.
Note: 'Rel. Day' = Relative Days / unsigned numbers mean days from first dose of fesoterodine + 1 / '-' prefixed numbers mean days beforefirst dose / '+' prefixed numbers mean days since last dose of fesoterodine; 'NA' = Not Applicable; '--' = Missing.
_______________________________________________________________________________________________________________________
SCHWARZ PHARMA CONFIDENTIAL 18FEB2009SPM 907 / Overactive BladderFinal Safety Update (Final)