|GLOBAL ADVERSE EVENT DATA COLLECTION FORM |Report Type Initial Follow-Up | |dd |mmm |yyyy |
| |Total # of pages: | Completed by: |J&J first notified | | | |
|Report # | |(print clearly) | | | | |
| |Vendor #: | | | | | |
|Vendor: | | | | | | |
| | | | Date of report: | | | |

|Serio| Serious Criteria | Death |
|us |Check all that apply |Disability |
| | |Life-Threatening |

|Initi| Initial Reporter: Consumer Physician Specialization: Pharmacist Nurse Lawyer Anonymous |
|al |Other (Dentist, etc.) Language: English Other |
|Repor| |
|ter | |
| |Title: First Name: Family Name: |
| |Address City: |
| |State/Province/Region: Postal Code: Country: Ph: |
| |Fax: E-mail address: @ Practice Name: |
| | Physician aware of event : Yes No U N/A Not Asked Permission to contact physician: Yes No U N/A Not Asked |
|Patie| Is this report solicited : JNJ Program number: |Reporter is Patient Initials: Anonymous Unknown |
|nt | | |
| |Date of |dd | | Sex: Age: Age at time of AE onset: Ethnicity: |
| |Birth: |mmm | |Height: in cm Weight at time of AE onset: lbs kg |
| | |yyyy | | |
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| | Enter Medical History and | |Pregnancy: Not Asked |Pregnancy: Last Menstrual |dd |
| |Concomitant Medications on Page | |N/A |Period: |mmm |
| |2 | |U No Yes | |yyyy |
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| | | | | |Start Date |Stop Date |
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|QA | |Was a Product Quality Complaint associated with this AE? Yes No If yes, describe in narrative; and enter reference number here: |
|Adver|Even|Serious |
|se |t(s)| |
|Event|– | |
|(AE) |List| |
|Descr|and | |
|iptio|Desc| |
|n |ribe| |
| |In | |
| |Narr| |
| |ativ| |
| |e | |
| |Form| |
|Narra| | Narrative description of course of events including body site & severity & outcome. Include pertinent details in chronological order: (if more space needed |
|tive | |continue on pg 2 –addtl info) |
| | | |

| |Concomitant Medications : Not Asked Refused U None Yes |
|Concom| |
|itant | |
|Medica| |
|tions | |
| | Product name (generic/trade): | Indication: | Dose/ Formulation/Strength/ |Therapy Dates |
| | | |Frequency/Route | |
| | | | |Start Date |Stop Date |
| | |
|Medic|Allergies: Not Asked Refused No Known Allergies No Known Drug Allergies Yes: |
|al |Drug Abuse/Illicit Drug Use: Not Asked Refused U No Yes specify: |
| |Alcohol: Not Asked Refused U No Yes drinks: (indicate: per day, week, month) |
| |Smoking: Not Asked Refused U No Yes cigarettes: (indicate: per day, week, month) |
|Diagn|Diagnostic Data : Not Asked Refused U None Yes |
|ostic| |
|Data | |
| | Lab Test (Including: Diagnostic |Date |Results |
| |Imaging, ECG, Biopsy, etc.) | | |
| | |dd |mmm |yyyy | |
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|Other| Other Contact: If Other Contact, complete remainder of section, otherwise leave blank: |
|Repor|Physician Pharmacist Nurse Lawyer Anonymous Consumer Company Rep Other(Dentist, etc) |
|ter/ |Language: English Other |
|Conta|Title: First Name: Family Name: |
|ct |Address: City: |
| |State/Province/Region: Postal Code: Country: Ph: |
| |Fax: E-mail address: @ Practice Name: |
|Addit|Use if additional space is needed for any field/section of page 1 or 2 |
|ional| |
|Infor| |
|matio| |
|n | |

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