Download serious adverse experience - Mectizan Donation Program

SERIOUS ADVERSE EXPERIENCE
REPORT
for the
Onchocerciasis Treatment Program
A serious adverse experience (SAE) is defined as an adverse experience following treatment with a drug that
results in any of the following:
 death
 life-threatening adverse drug experience
 in-patient hospitalization or prolongation of an existing hospitalization
 persistent or significant disability/incapacity
 congenital anomaly or birth defect
 cancer
 overdose (accidental or intentional)
Important medical events that may not result in death, be life-threatening, or require hospitalization may be
considered a serious adverse drug experience when, based upon appropriate medical judgment, they may
jeopardize the patient or subject, and may require medical or surgical intervention to prevent one of the
outcomes listed in the definition above: such events should also be reported.
COMPLETE THIS FORM ONLY IF THE
ADVERSE EXPERIENCE MEETS
THE ABOVE CRITERIA
and
send it promptly to:
Mectizan Donation Program
325 Swanton Way
Decatur, GA 30030
USA
TEL: +1-404-371-1460
FAX: +1-404-371-1138
E-mail: [email protected]
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Annex VI-D May08
Serious Adverse Experience (SAE) Report
Onchocerciasis Treatment Program
Country:
Date of Report:
/
/
(Day/Month/Year)
1. Patient Information
Name (First/Middle/Last)
Age (yr.)
Village
District
Sex (M/F)
Province
2. Pre-existing Conditions
Health Status before treatment with Mectizan (including any CNS disability):
Parasitic Infections
1. Onchocerciasis

2. Loiasis

If Loiasis is confirmed 
Confirmed
Suspected
mf/ml (blood):
Unknown
… or mf/smear:
Other parasitic infections, known or suspected (e.g. Malaria)
Negative
Details
mf/ml (CSF):

Other medications being taken (currently or recently)

Is patient pregnant?
Yes
No
Unknown
Alcohol: a) Consumption of alcohol within 24hrs of taking Mectizan


b) History of Chronic Alcoholism
3. Information on Recent Mectizan Treatment
Date of treatment (Day/Month/Year):
Source of treatment:
Community treatment program
Clinic or physician treatment
Other method
/
/
Dose of Mectizan
administered
(no. of tablets)
Was this a first treatment with Mectizan?
Yes
Patient’s height
(cm)
No
Patient’s weight
(kg)
Unknown
If “No”, explain when and circumstances of past treatment(s):
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Annex VI-D May08
4. Description of the Serious* Adverse Experience (SAE)
/
/
hours OR
Date of onset (Day/Month/Year)
days
How long after Mectizan was taken?
Clinical signs and symptoms

Were there signs of acute alcohol intoxication on initial examination ?:
Yes
No
Unknown
Dates of tests
(Day/Month/Year)
Laboratory results
/
/
/
/
/
/
Case management, clinical course, drugs used (e.g. Hospitalization – provide date of admission and
summarize the reason for admission):
a) Hospitalization:
If “Yes”, indicate:
Yes
No
Date of admission (Day/Month/Year):
/
/
Date of discharge (Day/Month/Year) :
/
/
(Attach any relevant reports)
b) Drug treatments administered:
*A serious adverse drug experience is an adverse experience occurring at any dose that results in any of the following
outcomes: death, a life-threatening adverse drug experience, in-patient hospitalization or prolongation of an existing
hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, a cancer, or an overdose
(whether accidental or intentional).
Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a
serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject
and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
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Annex VI-D May08
5. Condition/Outcome at time of last observation
Full recovery:
Yes
No
Unknown
Ongoing illness:
Yes
No
Unknown
Persistent/Significant Disability/Incapacity:
Yes
No
Unknown
If “Yes”, describe:
Death:
Yes
Date of death
(day/month/year)
No
If “Yes”, indicate
/
Cause of death
/
In fatal cases please provide circumstances at the time of death in detail below. Report any autopsy
findings made including tissues taken for histopathology and any additional studies done or requested
(use additional pages necessary to complete your answers):
Presumptive diagnosis:
6. Conclusions
Do you think the treatment with Mectizan was a causative possible factor in this SAE?
Yes
No
Not sure
If “Yes”, explain:
If “No”, or “Not sure”, what do you believe was the cause of the event?
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Annex VI-D May08
7. Source (reporter(s) of the data in this form)
Name of person making the report 
Title 
Organization 
Address 
Telephone number 
Fax number 
Please send this report to the following:
Mectizan Donation Program
325 Swanton Way
Decatur, GA 30030
USA
TEL: +1-404-371-1460
FAX: +1-404-371-1138
E-mail: [email protected]
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Annex VI-D May08