Adverse Event Form Product Safety Adverse Event Form Initial Report Follow-Up Report Date of Receipt Report No Information about the patient who experienced the event: Initial Country Date of Birth Age Sex Reaction Onset Details of the reaction (including relevant Tests/Lab Data): What happened to the patient? Patient Dead Yes No Life-threatening Yes No Patient Hospitalized Yes No Significant Disability or Incapacity Yes No Which AGP drug involved: Brand / Generic Name Formulation Batch Number Daily dose Route of administration Did Reaction abate after stopping drug? Yes No NA Indication for Use Therapy Dates (From/ To) Therapy Duration Concomitant Drugs & Date of Administration (Exclude those used to treat reactions): Who reported the Adverse Event? Name Address Phone Email Physician Consumer Other Specify Submit
