ID

44327

Description

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.

Link

www.ichom.org

Keywords

Versions (3)
  1. 8/22/18 8/22/18 - Sarah Riepenhausen
  2. 4/30/20 4/30/20 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
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ICHOM

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September 20, 2021

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Creative Commons BY-NC 4.0
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ICHOM Localized Prostate Cancer

English

Clinical Form annually after treatment initiation

1 forms  
Patient ID
Description

Patient ID

Alias
UMLS CUI-1
C1269815
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Time Relative to Baseline (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
Description

This Item does not exist in the original standard set, instead it is asked to do the following: 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. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Treatment Variables
Description

Treatment Variables

Alias
UMLS CUI-1
C0087111
Indicate whether the patient has undergone salvage therapy in the last year
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C4086728
Indicate which treatment modalities were used for salvage therapy 1 = Radical prostatectomy
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0194810
Indicate which treatment modalities were used for salvage therapy 2 = External beam radiation therapy
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C1517033
Indicate which treatment modalities were used for salvage therapy 3 = Brachytherapy
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0006098
Indicate which treatment modalities were used for salvage therapy 4 = Androgen deprivation therapy
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0279492
Indicate which treatment modalities were used for salvage therapy 5 = Focal therapy
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205234
Indicate which treatment modalities were used for salvage therapy 888 = Other
Description

INCLUSION CRITERIA: All patients TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205394
Indicate the other salvage treatment modality used
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205394
Indicate date of radical prostatectomy
Description

INCLUSION CRITERIA: All patients, If answered 'Radical prostatectomy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate if the surgical approach was nerve-sparing or non-nerve-sparing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C1514120
UMLS CUI [1,2]
C1512698
UMLS CUI [1,3]
C0085405
Indicate the total dose of External Beam Radiation Therapy
Description

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

Data type

integer

Measurement units
  • Gy
Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0085405
Gy
Indicate the average dose per fraction of External Beam Radiation Therapy
Description

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

Data type

float

Measurement units
  • Gy
Alias
UMLS CUI [1,1]
C0860348
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264633
UMLS CUI [1,4]
C0085405
Gy
Indicate start date of external beam radiation therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate stop date of external radiation therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate if external beam radiation therapy is ongoing
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0085405
Indicate start date of brachytherapy
Description

INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate stop date of brachytherapy
Description

INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate if brachytherapy is ongoing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0085405
Indicate whether high-dose or low-dose brachytherapy was given
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0006098
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0085405
Indicate start date of androgen deprivation therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate stop date of androgen deprivation therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C0085405
DD/MM/YYYY
Indicate if androgen deprivation therapy is ongoing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0085405
Indicate start date of focal therapy
Description

INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0808070
DD/MM/YYYY
Indicate stop date of focal therapy
Description

INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0806020
DD/MM/YYYY
Indicate if focal therapy is ongoing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0549178
Indicate start date of other therapy
Description

INCLUSION CRITERIA: All patients, If answered 'Other' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
DD/MM/YYYY
Indicate stop date of other therapy
Description

INCLUSION CRITERIA: All patients, If answered 'Other' (SALVAGETX) TIMING: Annually after salvage treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0806020
DD/MM/YYYY
Indicate if other therapy is ongoing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0085405
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0549178
Acute Complications of Treatment
Description

Acute Complications of Treatment

Alias
UMLS CUI-1
C0679861
UMLS CUI-2
C0085405
Indicate whether patient experienced a Clavien grade III-V complication
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: Occurring within 6 months after primary or salvage radical prostatectomy REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C4524868
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
Description

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

Data type

integer

Alias
UMLS CUI [1]
C1516728
If yes, note domain and grade 0 = No grade 3 or 4 toxicity
Description

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)

Data type

boolean

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0549184
If yes, note domain and grade 1/2 = Fatigue grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0015672
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0034561
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0011991
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0000737
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C1328588
If yes, note domain and grade 11/12 = Proctitis grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0033246
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0600142
If yes, note domain and grade 15/16 = Cystitis grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0010692
If yes, note domain and grade 17/18 = Urinary retention
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0080274
If yes, note domain and grade 19/20 = Other grade 3/4
Description

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)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0205394
Indicate the CTCAE domain of the grade 3 or 4 complication
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2699044
Survival and Disease Control
Description

Survival and Disease Control

Alias
UMLS CUI-1
C1148433
UMLS CUI-2
C0920467
Indicate if the patient has died
Description

INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0011065
Indicate date of death
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate if death is noted to be directly attributable to prostate cancer
Description

INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0600139
Indicate if patient was diagnosed with metastatic disease
Description

INCLUSION CRITERIA: All patients TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0600139
Indicate date of metastasis
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C2316983
DD/MM/YYYY
Indicate whether patient has biochemical recurrence
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0278838
UMLS CUI [1,2]
C0205474
Indicate date of recurrence
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0278838
UMLS CUI [1,2]
C0205474
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate PSA value
Description

INCLUSION CRITERIA: All patients, If answered 'yes' on biochemical recurrence (BIOCHEM) TIMING: Collected for life, reported annually REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

float

Measurement units
  • ng/mL
Alias
UMLS CUI [1,1]
C0278838
UMLS CUI [1,2]
C0205474
UMLS CUI [1,3]
C0138741
ng/mL
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Similar models

Clinical Form annually after treatment initiation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient ID
C1269815 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Treatment Variables
C0087111 (UMLS CUI-1)
Item
Indicate whether the patient has undergone salvage therapy in the last year
integer
C0085405 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Salvage treatment initiated (within last year?)
Code List
Indicate whether the patient has undergone salvage therapy in the last year
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Salvage treatment modalities used: Radical prostatectomy
Item
Indicate which treatment modalities were used for salvage therapy 1 = Radical prostatectomy
boolean
C0085405 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
Salvage treatment modalities used: External beam radiation therapy
Item
Indicate which treatment modalities were used for salvage therapy 2 = External beam radiation therapy
boolean
C0085405 (UMLS CUI [1,1])
C1517033 (UMLS CUI [1,2])
Salvage treatment modalities used: Brachytherapy
Item
Indicate which treatment modalities were used for salvage therapy 3 = Brachytherapy
boolean
C0085405 (UMLS CUI [1,1])
C0006098 (UMLS CUI [1,2])
Salvage treatment modalities used: Androgen deprivation therapy
Item
Indicate which treatment modalities were used for salvage therapy 4 = Androgen deprivation therapy
boolean
C0085405 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
Salvage treatment modalities used: Focal therapy
Item
Indicate which treatment modalities were used for salvage therapy 5 = Focal therapy
boolean
C0085405 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Salvage treatment modalities used: Other
Item
Indicate which treatment modalities were used for salvage therapy 888 = Other
boolean
C0085405 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Salvage treatment modality other than those explicitly listed
Item
Indicate the other salvage treatment modality used
text
C0085405 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Date of radical prostatectomy
Item
Indicate date of radical prostatectomy
date
C0194810 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Item
Indicate if the surgical approach was nerve-sparing or non-nerve-sparing
integer
C1514120 (UMLS CUI [1,1])
C1512698 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Primary nerve sparing status
Code List
Indicate if the surgical approach was nerve-sparing or non-nerve-sparing
CL Item
Non-nerve-sparing (1)
C0033573 (UMLS CUI-1)
C0445089 (UMLS CUI-2)
(Comment:en)
CL Item
Nerve-sparing (2)
C1514120 (UMLS CUI-1)
(Comment:en)
External Beam Radiation Therapy: Dose (Gray)
Item
Indicate the total dose of External Beam Radiation Therapy
integer
C1517033 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
External Beam Radiation Therapy: Average dose per fraction (Gray)
Item
Indicate the average dose per fraction of External Beam Radiation Therapy
float
C0860348 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264633 (UMLS CUI [1,3])
C0085405 (UMLS CUI [1,4])
Start date of external beam radiation therapy
Item
Indicate start date of external beam radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Stop date of external beam radiation therapy
Item
Indicate stop date of external radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Item
Indicate if external beam radiation therapy is ongoing
text
C1517033 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Ongoing primary external beam radiation therapy
Code List
Indicate if external beam radiation therapy is ongoing
CL Item
Treatment ongoing (1)
C1517033 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of brachytherapy
Item
Indicate start date of brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Stop date of brachytherapy
Item
Indicate stop date of brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Item
Indicate if brachytherapy is ongoing
integer
C0006098 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Ongoing primary brachytherapy
Code List
Indicate if brachytherapy is ongoing
CL Item
Treatment ongoing (1)
C0006098 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Item
Indicate whether high-dose or low-dose brachytherapy was given
integer
C0006098 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Primary brachytherapy dose
Code List
Indicate whether high-dose or low-dose brachytherapy was given
CL Item
Low dose (1)
C0454271 (UMLS CUI-1)
(Comment:en)
CL Item
High dose (2)
C0454270 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start date of androgen deprivation therapy
Item
Indicate start date of androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Stop date of androgen deprivation therapy
Item
Indicate stop date of androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Item
Indicate if androgen deprivation therapy is ongoing
integer
C0279492 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0085405 (UMLS CUI [1,3])
Ongoing primary androgen deprivation therapy
Code List
Indicate if androgen deprivation therapy is ongoing
CL Item
Treatment ongoing (1)
C0279492 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of focal therapy
Item
Indicate start date of focal therapy
date
C0085405 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of focal therapy
Item
Indicate stop date of focal therapy
date
C0085405 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if focal therapy is ongoing
integer
C0085405 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Ongoing primary focal therapy
Code List
Indicate if focal therapy is ongoing
CL Item
Treatment ongoing (1)
C0920425 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
Start date of other therapy
Item
Indicate start date of other therapy
date
C0085405 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of other therapy
Item
Indicate stop date of other therapy
date
C0085405 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if other therapy is ongoing
integer
C0085405 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Ongoing other therapy
Code List
Indicate if other therapy is ongoing
CL Item
Treatment ongoing (1)
C0920425 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
Item Group
Acute Complications of Treatment
C0679861 (UMLS CUI-1)
C0085405 (UMLS CUI-2)
Item
Indicate whether patient experienced a Clavien grade III-V complication
integer
C0009566 (UMLS CUI [1,1])
C4524868 (UMLS CUI [1,2])
Clavien complication (maximum grade)
Code List
Indicate whether patient experienced a Clavien grade III-V complication
CL Item
No (0)
C4032686 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, grade 3 (1)
C4050000 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, grade 4 (2)
C4050001 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
integer
C1516728 (UMLS CUI [1])
CTCAE grade 3 or 4 complication during treatment or within 6 months after completing treatment
Code List
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CTCAE domain and grade: None
Item
If yes, note domain and grade 0 = No grade 3 or 4 toxicity
boolean
C1516728 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item
If yes, note domain and grade 1/2 = Fatigue grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
CTCAE domain and grade: Fatigue
Code List
If yes, note domain and grade 1/2 = Fatigue grade 3/4
CL Item
No fatigue grade 3 or 4 toxicity (0)
C1556365 (UMLS CUI-1)
C1556364 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Fatigue grade 3 (1)
C1556364 (UMLS CUI-1)
(Comment:en)
CL Item
Fatigue grade 4 (2)
C1556365 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0034561 (UMLS CUI [1,2])
CTCAE domain and grade: Dermatitis
Code List
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
CL Item
No Dermatitis grade 3 or 4 toxicity (0)
C1298908 (UMLS CUI-1)
C1519275 (UMLS CUI-2)
C1517874 (UMLS CUI-3)
C0011603 (UMLS CUI-4)
(Comment:en)
CL Item
Dermatitis grade 3 (3)
C1519275 (UMLS CUI-1)
C0011603 (UMLS CUI-2)
(Comment:en)
CL Item
Dermatitis grade 4 (4)
C1517874 (UMLS CUI-1)
C0011603 (UMLS CUI-2)
(Comment:en)
Item
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])
CTCAE domain and grade: Diarrhea
Code List
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
CL Item
No Diarrhea grade 3 or 4 toxicity (0)
C1559310 (UMLS CUI-1)
C1559311 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Diarrhea grade 3 (5)
C1559310 (UMLS CUI-1)
(Comment:en)
CL Item
Diarrhea grade 4 (6)
C1559311 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0000737 (UMLS CUI [1,2])
CTCAE domain and grade: Abdominal Pain
Code List
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
CL Item
No Abdominal pain grade 3 or 4 toxicity (0)
C1557401 (UMLS CUI-1)
C1557400 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Abdominal pain grade 3 (7)
C1557400 (UMLS CUI-1)
(Comment:en)
CL Item
Abdominal pain grade 4 (8)
C1557401 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C1328588 (UMLS CUI [1,2])
CTCAE domain and grade: Rectal mucositis
Code List
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
CL Item
No Rectal mucositis grade 3 or 4 toxicity (0)
C1556390C1556391 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
CL Item
Rectal mucositis grade 3 (9)
C1556390 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal mucositis grade 4 (10)
C1556391 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 11/12 = Proctitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0033246 (UMLS CUI [1,2])
CTCAE domain and grade: Proctitis
Code List
If yes, note domain and grade 11/12 = Proctitis grade 3/4
CL Item
No Proctitis grade 3 or 4 toxicity (0)
C1559353 (UMLS CUI-1)
C1559354 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Proctitis grade 3 (11)
C1559353 (UMLS CUI-1)
(Comment:en)
CL Item
Proctitis grade 4 (12)
C1559354 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0600142 (UMLS CUI [1,2])
CTCAE domain and grade: Hot flashes
Code List
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
CL Item
No grade 3 or 4 toxicity (0)
C1559217 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
C0600142 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
CL Item
Hot flashes grade 3 (13)
C1559217 (UMLS CUI-1)
(Comment:en)
CL Item
Hot flashes grade 4 (14)
C1517874 (UMLS CUI-1)
C0600142 (UMLS CUI-2)
(Comment:en)
Item
If yes, note domain and grade 15/16 = Cystitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0010692 (UMLS CUI [1,2])
CTCAE domain and grade: Cystitis
Code List
If yes, note domain and grade 15/16 = Cystitis grade 3/4
CL Item
No Cystitis grade 3 or 4 toxicity (0)
C1557813 (UMLS CUI-1)
C1557814 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Cystitis non-infective grade 3 (15)
C1557813 (UMLS CUI-1)
(Comment:en)
CL Item
Cystitis non-infective grade 4 (16)
C1557814 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 17/18 = Urinary retention
integer
C1516728 (UMLS CUI [1,1])
C0080274 (UMLS CUI [1,2])
CTCAE domain and grade: Urinary retention
Code List
If yes, note domain and grade 17/18 = Urinary retention
CL Item
No Urinary retention grade 3 or 4 toxicity (0)
C1558145 (UMLS CUI-1)
C1558144 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Urinary retention grade 3 (17)
C1558144 (UMLS CUI-1)
(Comment:en)
CL Item
Urinary retention grade 4 (18)
C1558145 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 19/20 = Other grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
CTCAE domain and grade: Other
Code List
If yes, note domain and grade 19/20 = Other grade 3/4
CL Item
No other grade 3 or 4 toxicity (0)
C1519275 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
CL Item
Other grade 3 (19)
C1519275 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
CL Item
Other grade 4 (20)
C1517874 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
CTCAE domain other than those explicitly listed
Item
Indicate the CTCAE domain of the grade 3 or 4 complication
text
C1516728 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2699044 (UMLS CUI [1,3])
Item Group
Survival and Disease Control
C1148433 (UMLS CUI-1)
C0920467 (UMLS CUI-2)
Item
Indicate if the patient has died
integer
C0011065 (UMLS CUI [1])
Death: Patient died
Code List
Indicate if the patient has died
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Death: Date of death
Item
Indicate date of death
date
C1148348 (UMLS CUI [1])
Item
Indicate if death is noted to be directly attributable to prostate cancer
integer
C0007465 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Cause of death: Death attributable to localized prostate cancer
Code List
Indicate if death is noted to be directly attributable to prostate cancer
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate if patient was diagnosed with metastatic disease
integer
C0027627 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Disease control: Metastasis
Code List
Indicate if patient was diagnosed with metastatic disease
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Disease control: Date metastasis identified
Item
Indicate date of metastasis
date
C0027627 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Item
Indicate whether patient has biochemical recurrence
integer
C0278838 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
Disease control: Biochemical recurrence
Code List
Indicate whether patient has biochemical recurrence
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Disease control: Date biochemical recurrence identified
Item
Indicate date of recurrence
date
C0278838 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Disease control: Biochemical recurrence PSA value
Item
Indicate PSA value
float
C0278838 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0138741 (UMLS CUI [1,3])
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