ID
31443
Descrizione
LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 2017 www.ichom.org ICHOM Localized Prostate Cancer Standard Set was made possible only through the support of the Movember Foundation, an organization changing the face of men’s health. Conditions: Localized prostate cancer Treatment Approaches: Active Surveillance | Watchful Waiting | Radical Prostatectomy* | External Beam Radiation Therapy* | Androgen Deprivation Therapy (ADT)* | Focal Therapy* | Other* * These should also be collected as salvage treatments where necessary This ODM-file contains a Clinical Form to be used 6 months after primary treatment initiation. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: Expanded Prostate Cancer Index Composite (EPIC-26): The EPIC-26 is free for all health care organizations, and a license is not needed. The scoring guide may be found at http://www.med.umich.edu/urology/research/EPIC/EPIC-26-Scoring-1.2007.pdf ; Wei J, Dunn R, Litwin M, Sandler H, and Sanda M. "Development and Validation of the Expanded Prostate Cancer Index Composite (EPIC) for Comprehensive Assessment of Health-Related Quality of Life in Men with Prostate Cancer", Urology. 56: 899-905, 2000. For registries choosing to implement the EPIC-CP rather than the EPIC-26, we recommend using the same variable IDs as the corresponding EPIC-26 questions. This means that only questions 2, 3, 4a, 4b, 4d, 4e, 5, 6e, 6b, 7, 8b, 9, 12, 13a, 13c, and 13d of the EPIC-26 are administered. Utilization of Sexual Medications/Devices: The Utilization of Sexual Medications/Devices is free for all health care organizations, and a license is not needed. Refer to http://dx.doi.org/10.1016/j.urology.2006.01.077 for more information European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ- PR25): The EORTC QLQ-PR25 is free for all health care organizations, but a license is needed for use. Therefore it will not be integrated in this Version of the questionnaire. For more information, please visit http://groups.eortc.be/qol/eortc-qlq-c30 .
collegamento
Keywords
versioni (4)
- 22/08/18 22/08/18 - Sarah Riepenhausen
- 22/08/18 22/08/18 - Sarah Riepenhausen
- 30/04/20 30/04/20 - Sarah Riepenhausen
- 20/09/21 20/09/21 -
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ICHOM
Caricato su
22 agosto 2018
DOI
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Licenza
Creative Commons BY-NC 3.0
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ICHOM Localized Prostate Cancer
Clinical Form within 6 months after treatment initiation
- StudyEvent: ODM
Descrizione
Treatment Variables
Alias
- UMLS CUI-1
- C0087111
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1298659
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1827061
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0194810
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1517033
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0006098
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0279492
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205234
Descrizione
INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Multiple answer
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205394
Descrizione
INCLUSION CRITERIA: All patients If answered '7 = Focal therapy' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical or patient-reported TYPE: Free text
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205234
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Watchful waiting' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1298659
- UMLS CUI [1,2]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Active surveillance' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1827061
- UMLS CUI [1,2]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Radical prostatectomy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0194810
- UMLS CUI [1,2]
- C0011008
Descrizione
INCLUSION CRITERIA: All patients, If answered '3 = Radical prostatectomy' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single Answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1514120
- UMLS CUI [1,2]
- C1512698
Descrizione
INCLUSION CRITERIA: All patients, If answered '4 = External beam radiation therapy (primary treatment or adjuvant following surgery)' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value
Tipo di dati
integer
Unità di misura
- Gy
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C2986497
Descrizione
INCLUSION CRITERIA: All patients, If answered '4 = External beam radiation therapy (primary treatment or adjuvant following surgery)' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value
Tipo di dati
float
Unità di misura
- Gy
Alias
- UMLS CUI [1,1]
- C0860348
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1264633
Descrizione
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0806020
Descrizione
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX), and no end date is entered (PREBRTTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0549178
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0806020
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX), and no end date is entered (PRBRACHYTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0549178
Descrizione
INCLUSION CRITERIA: All patients, If answered '3 = Brachytherapy' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0178602
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0806020
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX), and no end date is entered (PRADTTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0549178
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0806020
Descrizione
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0549178
Descrizione
INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Free text
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205394
Descrizione
INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Descrizione
INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo di dati
date
Unità di misura
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Descrizione
INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Descrizione
Acute Complications of Treatment
Alias
- UMLS CUI-1
- C0679861
Descrizione
INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: Occurring within 6 months after primary or salvage radical prostatectomy REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0009566
- UMLS CUI [1,2]
- C4055231
Descrizione
INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Single answer
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C1516728
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Fatigue - Grade 1: Fatigue relieved by rest - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL - Grade 3: Fatigue not relieved by rest, limiting self care ADL - Grade 4: N/A Dermatitis radiation - Grade 1: Faint erythema or dry desquamation - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Diarrhea - Grade 1: Increase of less than 4 stools per day over baseline; mild increase in ostomy output compared to baseline - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline - Grade 3: Increase of 7 or more stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Abdominal pain - Grade 1: Mild pain - Grade 2: Moderate pain; limiting instrumental ADL - Grade 3: Severe pain; limiting self care ADL - Grade 4: N/A Rectal mucositis - Grade 1: Asymptomatic or mild symptoms; intervention not indicated - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: Life-threatening consequences; urgent operative intervention indicated Proctitis - Grade 1: Rectal discomfort, intervention not indicated - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Hot flashes - Grade 1: Mild symptoms; intervention not indicated - Grade 2: Moderate symptoms; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: N/A Cystitis non-infective - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated Urinary retention - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0549184
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Fatigue - Grade 1: Fatigue relieved by rest - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL - Grade 3: Fatigue not relieved by rest, limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0015672
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Dermatitis radiation - Grade 1: Faint erythema or dry desquamation - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0034561
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Diarrhea - Grade 1: Increase of less than 4 stools per day over baseline; mild increase in ostomy output compared to baseline - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline - Grade 3: Increase of 7 or more stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0011991
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Abdominal pain - Grade 1: Mild pain - Grade 2: Moderate pain; limiting instrumental ADL - Grade 3: Severe pain; limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0000737
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Rectal mucositis - Grade 1: Asymptomatic or mild symptoms; intervention not indicated - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: Life-threatening consequences; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C1328588
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Proctitis - Grade 1: Rectal discomfort, intervention not indicated - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0033246
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Hot flashes - Grade 1: Mild symptoms; intervention not indicated - Grade 2: Moderate symptoms; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0600142
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Cystitis non-infective - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0010692
Descrizione
The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Urinary retention - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0080274
Descrizione
INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0205394
Descrizione
INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy, If answered '19 = Other grade 3' or '20 = Other grade 4' on CTCAE domain and grade (COMPLRADDOMGRA) TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Free text
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2699044
Similar models
Clinical Form within 6 months after treatment initiation
- StudyEvent: ODM
C1442488 (UMLS CUI [1,2])
C1827061 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,2])
C1517033 (UMLS CUI [1,2])
C0006098 (UMLS CUI [1,2])
C0279492 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1512698 (UMLS CUI [1,2])
C0445089 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C2986497 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C1264633 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI-2)
(Comment:en)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI-2)
(Comment:en)
C0178602 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI-2)
(Comment:en)
C0205234 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0205234 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
C4055231 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0549184 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C1556364 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C0034561 (UMLS CUI [1,2])
C1519275 (UMLS CUI-2)
C1517874 (UMLS CUI-3)
C0011603 (UMLS CUI-4)
(Comment:en)
C0011603 (UMLS CUI-2)
(Comment:en)
C0011603 (UMLS CUI-2)
(Comment:en)
C0011991 (UMLS CUI [1,2])
C1559311 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C0000737 (UMLS CUI [1,2])
C1557400 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C1328588 (UMLS CUI [1,2])
C1298908 (UMLS CUI-2)
(Comment:en)
(Comment:en)
(Comment:en)
C0033246 (UMLS CUI [1,2])
C1559354 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C0600142 (UMLS CUI [1,2])
C1517874 (UMLS CUI-2)
C0600142 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
(Comment:en)
C0600142 (UMLS CUI-2)
(Comment:en)
C0010692 (UMLS CUI [1,2])
C1557814 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C0080274 (UMLS CUI [1,2])
C1558144 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
(Comment:en)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C1517874 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
C0205394 (UMLS CUI-2)
(Comment:en)
C0205394 (UMLS CUI-2)
(Comment:en)
C0205394 (UMLS CUI [1,2])
C2699044 (UMLS CUI [1,3])