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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 |
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