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)