FDA Adverse Event Reporting System (AERS) Report:
FDA Adverse Event Reporting System (AERS) Freedom of Information (FOI) Report:
Date: 10/17/03
ISR (Individual Safety Report) Number: 4214435-3
Report Type: Expedited (15-Day)
Company Report #: TPG2003A00337
Age: 85 YR
Gender: Male
Outcome: Death
Preferred Term: Death
Report Source: Health Professional
Product: Trenantone (Leuprolide Acetate) (11.25 Milligram, Injection)
Role: Primary Suspect
Manufacturer: TAKEDA CHEMICAL INDUST
Product: Flutamide 250 mg, Nitrosorbon Retard 60 (Isosorbide Dinitrate) Sustained Release, Aquaphor 40 (Xipamide), acetylsalicylic Acid 100 mg, Enalapril 10 mg Unknown, Molsidomin, Acc Long (Acetylcysteine 600 mg) (Nos)
Role: Concomitant
Route of Primary Suspect: SUBCUTANEOUS
Dose of Primary Suspect: 11.25 MG (11.25 MG, 1 IN 3 M)
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