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  1. 1. Guidlines
  2. 2. Patient Details
  3. 3. Adverse Event
  4. 4. Suspected Drug
  5. 5. Reporting


1. GUIDELINES TO FILL SERIOUS ADVERSE EVENT REPORT FORM





An adverse event is “Serious”, if it
• Is life threatening • Results in permanent disability
• Results in hospitalization • Is associated with death
• Prolongation of hospitalization • Causes a birth defect
• Causes malignancy • Causes a relevant organ toxicity
• Is an overdose resulting in clinically Relevant signs and / or symptoms



An adverse drug event can be a manifestation of various etiologies such as
• Complication of an underlying disease                                               • Intercurrent disease
• Coincidental accident • Drug associated effect
• Concomitant medication


                                                                                                                                                                                                 

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