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Page 1

0 6 MAY 2004

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A15778-001

A15778 event description: part 1
PROactive Centre number Patient initials Patient number
49013 014
Reason for alert report:
(tick all that apply)
Complete pages 001 and 002 for all events, complete additional pages as indicated
Serious 1
or adverse
event
Episode of chest
pain / discomfort
Coronary
revascularisation
Cerebrovascular
event
Amputation /
revascularisation
of the leg
complete page 003 complete page 004 complete page 004
Other hospitalisation 2
see note 2
Medical event (diagnosis) 3 benign tumor of the urinary bladder
Seriousness
(tick all that apply)
Date of onset
day month year
10 10 04
Fatal Complete death
report in CRF
Life-threatening Relationship to study medication 4
(tick only one)
Required or prolonged hospitalisation Definite
Persistent or significant disability or incapacity Probable
Congenital anomaly Possible
Important medical event Unlikely / unrelated
Does not meet definition of serious adverse event
Study Medication
Medication ongoing
at onset of event?
yes → Date first
started
day month year
05 11 04
→ Current dose
at event onset
no → Date first
started
day month year 45 mg 30 mg 15 mg
not yet started → Date
stopped
Details (Please write in English)
(include relevant medical history, course of the event, diagnostic evaluations and management)
10/10/04 - 10/12/04 v. Hospitalisation because of an tumor
of the urinary bladder: 16/12/04 or surgery
Histology: Benign tumor