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ID
5474
Description
CWS-2007-HR: A randomised phase-III trial of the Cooperative Soft-Tissue-Study-Group for localised high-risk rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults http://clinicaltrials.gov/show/NCT00876031 http://www.cws.olgahospital-stuttgart.de
Link
http://clinicaltrials.gov/show/NCT00876031
Keywords
Versions (1)
- 8/6/14 8/6/14 - Martin Dugas
Uploaded on
August 6, 2014
DOI
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License
Creative Commons BY 4.0
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CWS-2007-HR B5 - Therapieabschlussbogen DRKS00003774
B5 - Therapieabschlussbogen
- StudyEvent: SE
Similar models
B5 - Therapieabschlussbogen
- StudyEvent: SE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Dummy item in ItemGroup 'Display patient'
Item
Patient
text
Ende Beobachtungszeitraum bei protokollgerechtem Ablauf (berechneter Richtwert)
Item
End of protocol compliant observation time (computed point of refereence)l
date
Therapie(Arm B) bzw. Beobachtungszeitraum (Arm A) beendet am
Item
Therapy( arm B) / surveillance (arm A) completed
date
CL Item
yes, per protocol (1)
CL Item
no, abortion because of toxicity (2)
CL Item
no, abortion because of relapse (3)
CL Item
no, abortion b. patient's decision (4)
CL Item
no, death (5)
CL Item
no, refusal of randomisation result (6)
CL Item
no, other reason (7)
anderer Abbruchgrund
Item
Detailed description
text
CL Item
no (2)
CL Item
yes (1)
Beschreibung des Events/Toxizität
Item
Description AE
text
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Beginn AE
Item
Start AE
date
Ende AE
Item
End AE
date
CL Item
not recovered/resolved (1)
CL Item
resolving (2)
CL Item
resolved with sequelae (3)
CL Item
resolved without sequelae (4)
CL Item
Death (5)
CL Item
Death, but not in relation SAE (6)
CL Item
unknown (7)
Bemerkung AE
Item
Notes
text
Therapie(Arm B) bzw. Beobachtungszeitraum (Arm A) beendet am
Item
Therapy( arm B) / surveillance (arm A) completed
date
CL Item
yes, per protocol (1)
CL Item
no, abortion because of toxicity (2)
CL Item
no, abortion because of relapse (3)
CL Item
no, abortion b. patient's decision (4)
CL Item
no, death (5)
CL Item
no, refusal of randomisation result (6)
CL Item
no, other reason (7)
anderer Abbruchgrund
Item
Detailed description
text
Item
Was any other additional treatment performed during CWS-2007-HR?
integer
CL Item
no (2)
CL Item
yes (1)
CL Item
no (2)
CL Item
yes (1)
CL Item
no (2)
CL Item
yes (1)
CL Item
no (2)
CL Item
yes (1)
Datum OP
Item
Date of surgery
date
CL Item
Biopsy (1)
CL Item
Resection of primary tumour (2)
CL Item
Resection of lymph nodes (3)
CL Item
Resection of metastases (4)
CL Item
Other surgery (5)
Sonstige OP
Item
Other Surgery, description
text
Beginn der primären Radiotherape
Item
Start radiotherapy
date
Radiotherapie-Ende
Item
End radiotherapy
date
Bestralungs-Einzeldosis
Item
Dose [Gy] / day
float
Anzahl Fraktionierung
Item
Fractionation /d
integer
Gesamtdosis
Item
Cumulative dose [Gy]
float
Art der Sonstigen Therapie
Item
Type of therapy
text
CL Item
Remission (1)
CL Item
Progression (3)
CL Item
Relapse (4)
CL Item
death (5)
Datum letzte Untersuchung
Item
Last examination
date