Information:
Fel:
ID
43998
Beskrivning
NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster
Nyckelord
Versioner (2)
- 2016-07-08 2016-07-08 -
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC-ND 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
SAE Form RICH study NCT02669589
SAE Form RICH study NCT02669589
- StudyEvent: ODM
Similar models
SAE Form RICH study NCT02669589
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
CL Item
Inititial report (Inititial report)
CL Item
Follow-up report (Follow-up report)
Patient ID
Item
ID of patient
text
C2348585 (UMLS CUI [1])
Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Age
Item
Age at onset of SAE
float
C0001779 (UMLS CUI [1])
CL Item
male (male)
CL Item
female (female)
Weight
Item
Weight:
float
C0005910 (UMLS CUI [1])
Height
Item
Height:
float
C0005890 (UMLS CUI [1])
Sponsor
Item
Sponsor's Case No. (please leave empty)
text
C2347796 (UMLS CUI [1])
CL Item
Results in death (Results in death)
CL Item
Results in persistent or significant disability/incapacity (Results in persistent or significant disability/incapacity)
CL Item
Life-threatening (Life-threatening)
CL Item
Congenital anomaly/ birth defect (Congenital anomaly/ birth defect)
CL Item
Caused/prolonged inpatient hospitalisation (Caused/prolonged inpatient hospitalisation)
CL Item
Other medically important condition (Other medically important condition)
Date of death
Item
If SAE results in death: Date of death
date
C1148348 (UMLS CUI [1])
CL Item
Yes (if yes: Please attach copy of autopsy report) (Yes (if yes: Please attach copy of autopsy report))
CL Item
No (No)
Cause of death
Item
Cause of death (As given in certifiate of death):
text
C0007465 (UMLS CUI [1])
SAE: Diagnosis
Item
SAE: Diagnosis - only one diagnosis if possible - multiple entries only if signs, symptoms, or diagnoses cannot be merged to one diagnosis - multiple entries: rank by relevance. Enter most importnant sign, symptoms or diagnosis in first place
text
C2919019 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Severity
Item
CTCAE grade (Maximal grade)
text
C0439793 (UMLS CUI [1])
Onset date
Item
Onset date (if exact time is relevant: Please include it in the detailed description)
date
C0574845 (UMLS CUI [1])
CL Item
Recovered/resolved (1)
CL Item
Recovering/resolving (2)
CL Item
Not recovered/ resolved (3)
CL Item
Recovered/resolved with sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
End date
Item
End date (if ongoing, enter "cont.")
date
C0806020 (UMLS CUI [1])
Item
Possible explanation(s) for SAE (please check as many as apply, please add details on next pages)
text
C0392360 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Code List
Possible explanation(s) for SAE (please check as many as apply, please add details on next pages)
CL Item
Investigational treatment (1)
CL Item
Concomitant medication (2)
CL Item
Underlying disease (3)
CL Item
Pre-existing condition, concomitant/ intercurrent disease (4)
CL Item
other explanation (e.g. surgery/ radiotherapy) (5)
SAE: description
Item
SAE: Detailed description including symptoms
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
CL Item
None (None )
CL Item
Drug treatment (Drug treatment)
CL Item
Others (Others)
Treatment of SAE: Specification
Item
Treatment of SAE: Specification
text
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Drugs (Investigational drug/device - this is essential and mandatory information; Relevant concomitant medication - please do not enter any treatment of the SAE - Enter only drugs the patient started before the SAE)
C0013216 (UMLS CUI-1)
Brand name
Item
Brand name
text
C0592503 (UMLS CUI [1])
Active substance
Item
Active substance
text
C1254351 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
CL Item
Reasonable possibility (1)
CL Item
No reasonable possibility (2)
Therapy duration
Item
Therapy dates (from - to) (If ongoing: Enter "cont.")
text
C0444921 (UMLS CUI [1])
Total daily dose and unit
Item
Total daily dose and unit
text
C2348070 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Route of administration
Item
Route of administration (e.g. oral, iv, sc)
text
C0013153 (UMLS CUI [1])
Total absolute cumulative dose and unit
Item
Total absolute cumulative dose and unit: (if relevant; from first administration until last administration prior to SAE; only relevant for investigational drug/device)
text
C2986497 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Item
Action taken in response to SAE (if pateinte was already off therapy with this drug prior to SAE: Enter 6)
text
C0441472 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Code List
Action taken in response to SAE (if pateinte was already off therapy with this drug prior to SAE: Enter 6)
CL Item
Dose not changed (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug withdrawal (4)
CL Item
Unknown (5)
CL Item
Not applicable (6)
Item
If drug was withdrawn: Has drug been re-administered? (Only for investigational drug/device)
text
C0376495 (UMLS CUI [1])
Code List
If drug was withdrawn: Has drug been re-administered? (Only for investigational drug/device)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
If drug was re-administered: Did reaction recur on re-administration? (Only for investigational drug/device)
text
C0376495 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
C0443286 (UMLS CUI [1,2])
Code List
If drug was re-administered: Did reaction recur on re-administration? (Only for investigational drug/device)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item Group
Relevant Medical History - Information pertinent to understanding the case: e.g. underlying disease, pre-existing condition, concomitant/ intercurrent disease, surgery
C0262926 (UMLS CUI-1)
Disease
Item
Condition/ disease:
text
C0012634 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
CL Item
Reasonable possibility (1)
CL Item
No reasonable possibility (2)
Item Group
Relevant results of tests and procedures - attach results/ findings, if appropriate
C0392366 (UMLS CUI-1)
C0184661 (UMLS CUI-2)
C0184661 (UMLS CUI-2)
Tests and procedures
Item
Tests and procedures:
text
C0392366 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0184661 (UMLS CUI [2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Result
Item
Result:
text
C2826772 (UMLS CUI [1])
Unit
Item
Unit of measurement
text
C1519795 (UMLS CUI [1])
Normal range - lower limit
Item
Normal range - lower limit
float
C1518030 (UMLS CUI [1])
Normal range - upper limit
Item
Normal range - upper limit
float
C1519815 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Family name
Item
Family name
text
C1301584 (UMLS CUI [1])
First name
Item
First name
text
C1443235 (UMLS CUI [1])
Institution address
Item
Address of institution:
text
C1301943 (UMLS CUI [1,1])
C0376649 (UMLS CUI [1,2])
C0376649 (UMLS CUI [1,2])
Telephone
Item
Telephone
text
C1515258 (UMLS CUI [1])
Fax
Item
Fax
text
C1549619 (UMLS CUI [1])
E-Mail
Item
E-Mail
text
C1705961 (UMLS CUI [1])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])