SERIOUS ADVERSE EVENT FORM - Universitätsklinikum Essen

EUDRACT No. : 2011-006204-13 SAE-REPORT Page 1 of 2
PROTOCOL IDENTIFICATION: PredCH
INDICATION: Cluster-Kopfschmerz
SPONSOR: Universitätsklinikum Essen, Hufelandstr.55, 45122 Essen
PLEASE TYPE OR PRINT LEGIBLY USING BLACK BALL-POINT PEN AND COMPLETE ALL INFORMATION
PATIENT CHARACTERISTICS
Patient No.
Sex
Age (years)) Height (cm) Weight (kg) SAE No.
M
F
REPORT INFORMATION
INITIAL REPORT
Date:
FOLLOW-UP REPORT
Date:
NAME OF INVESTIGATOR:
SITE NO.:
INSTITUTION:
E-MAIL:
COUNTRY:
TELEPHON:
FAX:
SERIOUSNESS CRITERIA OR REPORTABLE REASON
results in death
life-threatening
requires inpatient hospitalization / or prolongation
results in persistent or significant disability/incapacity
congenital anomaly / birth defect
other medically important condition
SERIOUS ADVERSE EVENT (SAE)
SAE: Diagnosis (if possible) including symptoms
Onset date of SAE
(DD/MM/YYYY)
Date of resolution
(DD/MM/YYYY)
Date of death
(if applicable)
(DD/MM/YYYY)
SEVERITY or CTC-GRADE
CTC-grade: CTC grade 1 CTC grade 2 CTC grade 3 CTC grade 4 CTC grade 5
or
Intensity: mild moderate severe
INVESTIGATIONAL DRUG(S) UNBLINDING: not applicable no yes
1.
Brand Name ® / Active Substance Name
Batch No.
Batch No.:
Date of first
administration
Time interval (incl. unit)
between last drug
administration and start
of event
Relatedness: related probably possibly unlikely not related not assessable
2.
Batch No.:
Relatedness: related probably possibly unlikely not related not assessable
3.
Batch No.:
Relatedness: related probably possibly unlikely not related not assessable
Daily dose, unit,
route of administration

PLEASE TYPE OR PRINT LEGIBLY USING BLACK BALL-POINT PEN AND COMPLETE ALL INFORMATION
PATIENT INFORMATION
Patient- No. Age (years) SAE No. INITIAL REPORT Date:
FOLLOW-UP Date:
RELEVANT MEDICAL HISTORY (pre-existing / concurrent conditions) Start date Stop date
1.
2.
3.
RELEVANT CONCOMITANT MEDICATION
Indication
Daily dose, unit,
route of
administration
Date of first
administration
Date of last
administration
1.
2.
3.
RELEVANT LAB FINDINGS OR INVESTIGATIONS
Normal range Date Result
1.
2.
3.
4.
TREATMENT OF SAE ACTION TAKEN WITH TRIAL MEDICATION OUTCOME OF SAE
none
drug treatment
others
Specify:
COMMENT:
dose not changed
dose reduced
dose increased
drug withdrawn, date: ___________
Has a rechallenge been done?
yes no unknown
Did reaction recur on readministration?
yes no unknown
unknown
not applicable
recovered / resolved
recovering / resolving
not recovered / not resolved
recovered / resolved with sequelae
fatal
cause of death:
autopsy? yes no
unknown
INVESTIGATOR SIGNATURE
Name Signature Date (DD/MM/YYYY)
FAX WITHIN 24 Hours TO PD. Dr. M. Obermann: FAX No. 0201-723-5542