ADR/SERIOUS ADVERSE EVENT FORM - Stop TB



ADVERSE DRUG REACTION/SERIOUS ADVERSE EVENT FORM

EVENT: CHECK ALL THAT APPLY

SERIOUS ADVERSE EVENT NON-SERIOUS ADVERSE DRUG REACTION

No of PAGES: INITIAL REPORT FOLLOW-UP REPORT

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|ADR/SAE | |

|DESCRIPTI|Please describe the ADR/SAE (Describe the course of events, timing and suspected causes): |

|ON |……………………………………………………………………………………………………………………..…………………………………………….. |

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NON-SERIOUS ADVERSE DRUG REACTION/SERIOUS ADVERSE EVENT FORM

(continued)

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| Initial Report Follow-up Report | | | | | |

|Patient|Sex: |Height: |Weight: |Date of Birth: |

| | Male | | |

| |Female | | |

|Onset | | | |

|ADR/SAE| Serious AE/ADR Non-Serious | Serious AE/ADR Non-Serious | Serious AE/ADR Non-Serious |

|Serious|please specify category ADR |please specify category ADR |please specify category ADR |

|ness |Death1 |Death1 |Death1 |

|Categor|Hospitalization required2 |Hospitalization required2 |Hospitalization required2 |

|y |Prolonged hospitalization |Prolonged hospitalization |Prolonged hospitalization |

| |Life threatening |Life threatening |Life threatening |

| |Persistent/significant disability |Persistent/significant disability |Persistent/significant disability |

| |Congenital anomaly/birth defect |Congenital anomaly/birth defect |Congenital anomaly/birth defect |

| |Other medically important condition |Other medically important condition |Other medically important condition |

|Relatio|ONLY APPLICABLE FOR |ONLY APPLICABLE FOR |ONLY APPLICABLE FOR |

|n to |SERIOUS AE’s/ADR’s |SERIOUS AE’s/ADR’s |SERIOUS AE’s/ADR’s |

|the |Not Related Possible |Not Related Possible |Not Related Possible |

|medicin|Doubtful Probable |Doubtful Probable |Doubtful Probable |

|e |Very likely |Very likely |Very likely |

|Outcome| Recovered/ Recovered/resolved | Recovered/ Recovered/resolved | Recovered/ Recovered/resolved |

| |resolved with sequelae |resolved with sequelae |resolved with sequelae |

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1 Record further death information on the following page in the ’SAE General’ section.

2 Record hospital admission date on the following page in the ’SAE General’ section.

NON-SERIOUS ADVERSE DRUG REACTION/SERIOUS ADVERSE EVENT FORM

(continued)

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| Initial Report Follow-up Report | | | | | |

|SAE | | | | |

|General| | | | |

| |Date of | | | | | | | |Primary cause of death (if known): …………………………………………………………………………… |

| |Death | | | | | | | |Was autopsy performed? |

| | | | | | | | | |No Yes (If yes, attach copy of report if available) |

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| | |d |d |M |O |N |y |y | |

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| |Hospital Admission Date | | | | |

|DOSING | | | | |

|OF THE | | | | |

|MEDICIN| | | | |

|E | | | | |

| | NAME OF MEDICINE |Batch/Lot No. |Dose |Unit |Frequency |Route |

| | |………………………………. |……………… |……………… |……………… |……..……………… |

|REPORTIN| |

|G |Reporter’s Statement |

| |Note: Please ensure Page 4 is completed prior to signing |

| |I have verified the data on this ADR/SAE report and have determined they are accurate and compatible with clinical notes. |

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| |Reporter’s Name: …………………………………………………………………………… (Please print) |

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| |Signature (required): ………………………………………………………………….……. | |

CONTINUE ON THE NEXT PAGE

ADVERSE DRUG REACTION/SERIOUS ADVERSE EVENT FORM (continued)

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| Initial Report Follow-up Report | | | | | |

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|MEDIC|Briefly describe disease and concurrent illness: |

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|HISTO| |

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|CONCO|Relevant Concomitant medications (include medications taken within 2 weeks prior to the first event): |

|MITAN| |

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|MEDIC| |

|ATION| |

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| |Drug |Dose |Frequency |Route |Start Date |End Date |Indication |

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|LAB |Test |Unit |Ref Range |Date |Result |

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PLEASE COMPLETE ALL PAGES AND EMAIL/FAX WITHIN 24 HOURS OF BECOMING AWARE OF A SERIOUS ADVERSE EVENT OR ADVERSE DRUG REACTION TO:

Global Drug Facility: gdf@

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