ID
40523
Descripción
LOCALIZED PROSTATE CANCER DATA COLLECTION Version 2.0.5 Revised: April 7th , 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. 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 annually after salvage 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 . ICHOM was supported for the Localized Prostate Cancer Standard Set by the Movember Foundation. Publication: Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460‐467. doi:10.1016/j.eururo.2014.08.075 For this version of the standard set, semantic annotation with UMLS CUIs has been added.
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Versiones (3)
- 22/8/18 22/8/18 - Sarah Riepenhausen
- 30/4/20 30/4/20 - Sarah Riepenhausen
- 20/9/21 20/9/21 -
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ICHOM
Subido en
30 de abril de 2020
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Creative Commons BY-NC 4.0
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ICHOM Localized Prostate Cancer
Clinical Form annually after treatment initiation
- StudyEvent: ODM
Descripción
Treatment Variables
Alias
- UMLS CUI-1
- C0087111
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C4086728
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0194810
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C1517033
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0006098
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0279492
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205234
Descripción
INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205394
Descripción
INCLUSION CRITERIA: All patients, If answered '888 = Other' on salvage treatment modalities used (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Free text
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205394
Descripción
INCLUSION CRITERIA: All patients, If answered 'Radical prostatectomy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0194810
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered '1 = Radical prostatectomy' on salvage treatment modalities (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single Answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1514120
- UMLS CUI [1,2]
- C1512698
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered '2 = External beam radiation therapy (salvage treatment or adjuvant following surgery)' on salvage treatment modalities (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value
Tipo de datos
integer
Unidades de medida
- Gy
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C2986497
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered '4 = External beam radiation therapy' on salvage treatment modalities (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value
Tipo de datos
float
Unidades de medida
- Gy
Alias
- UMLS CUI [1,1]
- C0860348
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C1264633
- UMLS CUI [1,4]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (SALVAGETX), and no end date is entered (SVEBRTTXSTOPDATE) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1517033
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (SALVAGETX), and no end date is entered (SVBRACHYTXSTOPDATE) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered '3 = Brachytherapy' on salvage treatment modalities (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0006098
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (SALVAGETX), and no end date is entered (SVADTTXSTOPDATE) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0279492
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C0085405
Descripción
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0808070
Descripción
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0806020
Descripción
INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (SALVAGETX), and no end date is entered (SVFOCTXSTOPDATE) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0549178
Descripción
INCLUSION CRITERIA: All patients, If answered 'Other' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Descripción
INCLUSION CRITERIA: All patients, If answered 'Other' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Descripción
INCLUSION CRITERIA: All patients, If answered 'Other' (SALVAGETX), and no end date is entered (SVOTHERTXONGOING) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0085405
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Descripción
Acute Complications of Treatment
Alias
- UMLS CUI-1
- C0679861
- UMLS CUI-2
- C0085405
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C0009566
- UMLS CUI [1,2]
- C4055231
Descripción
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 de datos
integer
Alias
- UMLS CUI [1]
- C1516728
Descripción
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 de datos
boolean
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0549184
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0015672
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0034561
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0011991
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0000737
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C1328588
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0033246
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0600142
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0010692
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0080274
Descripción
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 de datos
integer
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0205394
Descripción
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 de datos
text
Alias
- UMLS CUI [1,1]
- C1516728
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2699044
Descripción
Survival and Disease Control
Alias
- UMLS CUI-1
- C1148433
- UMLS CUI-2
- C0920467
Descripción
INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0011065
Descripción
INCLUSION CRITERIA: All patients, If answered 'yes' on overall survival (OVERALLSURV) TIMING: Collected for life, reported annually REPORTING SOURCE: Administrative data (Death registry) TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1]
- C1148348
Descripción
INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0600139
Descripción
INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0600139
Descripción
INCLUSION CRITERIA: Patients without known metastasis, If answered 'yes' on development of metastasis (METADEV) TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0027627
- UMLS CUI [1,2]
- C0600139
- UMLS CUI [1,3]
- C2316983
Descripción
Biochemical recurrence is defined as: - Per AUA definition, PSA>0.2 ng/mL after surgery, with a second confirmatory level of >0.2 ng/ml - Phoenix criteria (nadir + 2 ng/mL) after radiation Recommended that PSA is measured at least annually and providers record all PSA values and dates to accommodate future changes to definitions INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Single answer
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0278838
- UMLS CUI [1,2]
- C0205474
Descripción
INCLUSION CRITERIA: All patients, If answered 'yes' on biochemical recurrence (BIOCHEM) TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
Tipo de datos
date
Unidades de medida
- DD/MM/YYYY
Alias
- UMLS CUI [1,1]
- C0278838
- UMLS CUI [1,2]
- C0205474
- UMLS CUI [1,3]
- C0011008
Descripción
INCLUSION CRITERIA: All patients, If answered 'yes' on biochemical recurrence (BIOCHEM) TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Numerical value
Tipo de datos
float
Unidades de medida
- ng/mL
Alias
- UMLS CUI [1,1]
- C0278838
- UMLS CUI [1,2]
- C0205474
- UMLS CUI [1,3]
- C0138741
Similar models
Clinical Form annually after treatment initiation
- StudyEvent: ODM
C1442488 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
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])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C1512698 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0445089 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C2986497 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1264633 (UMLS CUI [1,3])
C0085405 (UMLS CUI [1,4])
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0549178 (UMLS CUI-2)
(Comment:en)
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0549178 (UMLS CUI-2)
(Comment:en)
C0178602 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
(Comment:en)
(Comment:en)
(Comment:en)
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
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])
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)
C0085405 (UMLS CUI-2)
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])
C0920467 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0600139 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
C0600139 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0600139 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C0205474 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0205474 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0205474 (UMLS CUI [1,2])
C0138741 (UMLS CUI [1,3])