Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Birthdate
Item
Patient date of birth
date
C0421451 (UMLS CUI [1])
Visit number
Item
At which visit has the SAE occurred?
integer
C1549755 (UMLS CUI [1])
Item
Patient Gender
text
C0079399 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Date of occurrence
Item
When did the SAE occur? Please note day/month/year
date
C0011008 (UMLS CUI [1,1])
C2697887 (UMLS CUI [1,2])
Description of SAE
Item
Please describe anything relevant to this specific event: clinically relevant findings,laboratory results, medical history and comorbidities
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Medication
Item
Applied medication with lot number, please include also the investigational product.
text
C0013227 (UMLS CUI [1])
Daily dose
Item
Daily dose of medication
float
C2348070 (UMLS CUI [1])
Drug application route
Item
Drug application route (i.e: i.v, s.c, i.m,oral,...)
text
C0013153 (UMLS CUI [1])
Medication use start date
Item
Medication use start date
date
C0240320 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication use end date
Item
Medication use end date
date
C0240320 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Is the SAE related to the pharmaceutical product?
text
C0013227 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Code List
Is the SAE related to the pharmaceutical product?
CL Item
no correlation (1)
CL Item
inconclusive/insufficent data (5)
Lifethreatening
Item
Lifethreatening adverse event
boolean
C1517874 (UMLS CUI [1])
Hospitalization
Item
Event resulted in a hospitalization
boolean
C0019993 (UMLS CUI [1])
Date of hospital admission
Item
Date of hospital admission
date
C0806429 (UMLS CUI [1])
Treatment methods
Item
Please describe treatment (i.e chronological sequence, determining factors, discontinuation of medication, clinical condition of the patient at this point)
text
C0679624 (UMLS CUI [1])
Attached documents
Item
Please describe any attached documents (hospital report, lab results or other tests contributing to the diagnosis)
text
C1999228 (UMLS CUI [1])
Item
What ist the result of the reported SAE?
text
C1547647 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
What ist the result of the reported SAE?
CL Item
Recovered with persisting sequelae (2)
Death Related to Adverse Event
Item
Death related to Serious Adverse Event
boolean
C1705232 (UMLS CUI [1])
Death context to trial substance
Item
Death of the patient is not related to the trial substance
boolean
C2983596 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])