ID

40545

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 6 months after primary treatment initiation. Surveys 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. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Link

www.ichom.org

Keywords

  1. 8/22/18 8/22/18 - Sarah Riepenhausen
  2. 8/22/18 8/22/18 - Sarah Riepenhausen
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
  4. 9/20/21 9/20/21 -
Copyright Holder

ICHOM

Uploaded on

April 30, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

ICHOM Localized Prostate Cancer

Clinical Form within 6 months after treatment initiation

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 the primary treatment modalities used for this patient 1 = Watchful waiting
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1]
C1298659
Indicate the primary treatment modalities used for this patient 2 = Active surveillance
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1827061
Indicate the primary treatment modalities used for this patient 3 = Radical prostatectomy
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0194810
Indicate the primary treatment modalities used for this patient 4 = External beam radiation therapy (primary treatment or adjuvant following surgery)
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1517033
Indicate the primary treatment modalities used for this patient 5 = Brachytherapy
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0006098
Indicate the primary treatment modalities used for this patient 6 = Androgen deprivation therapy
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0279492
Indicate the primary treatment modalities used for this patient 7 = Focal therapy
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205234
Indicate the primary treatment modalities used for this patient 888 = Other
Description

INCLUSION CRITERIA: All patients TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
Indicate the type of focal therapy used for this patient
Description

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 TYPE: Free text

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205234
Indicate date watchful waiting initiated
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1298659
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Inidicate date active surveillance initiated
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1827061
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Indicate date of primary radical prostatectomy
Description

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

Data type

date

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

float

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

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

Data type

date

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

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

Data type

date

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

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

Data type

text

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

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

Data type

date

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

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

Data type

date

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

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

Data type

integer

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

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

Data type

integer

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

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

Data type

date

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

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

Data type

date

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

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

Data type

integer

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

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0808070
DD/MM/YYYY
Indicate stop date of primary focal therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0806020
DD/MM/YYYY
Indicate if primary focal therapy is ongoing
Description

INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0549178
Indicate the other primary treatment modality used
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
Indicate start date of other primary therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0808070
DD/MM/YYYY
Indicate stop date of other primary therapy
Description

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

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0806020
DD/MM/YYYY
Indicate if other primary therapy is ongoing
Description

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

Data type

integer

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0549178
Acute Complications of Treatment
Description

Acute Complications of Treatment

Alias
UMLS CUI-1
C0679861
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]
C4055231
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

Similar models

Clinical Form within 6 months after treatment initiation

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)
Treatment modalities used: Watchful waiting
Item
Indicate the primary treatment modalities used for this patient 1 = Watchful waiting
boolean
C1298659 (UMLS CUI [1])
Treatment modalities used: Active surveillance
Item
Indicate the primary treatment modalities used for this patient 2 = Active surveillance
boolean
C0920425 (UMLS CUI [1,1])
C1827061 (UMLS CUI [1,2])
Treatment modalities used: Radical prostatectomy
Item
Indicate the primary treatment modalities used for this patient 3 = Radical prostatectomy
boolean
C0920425 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
Treatment modalities used: External beam radiation therapy
Item
Indicate the primary treatment modalities used for this patient 4 = External beam radiation therapy (primary treatment or adjuvant following surgery)
boolean
C0920425 (UMLS CUI [1,1])
C1517033 (UMLS CUI [1,2])
Treatment modalities used: Brachytherapy
Item
Indicate the primary treatment modalities used for this patient 5 = Brachytherapy
boolean
C0920425 (UMLS CUI [1,1])
C0006098 (UMLS CUI [1,2])
Treatment modalities used: Androgen deprivation therapy
Item
Indicate the primary treatment modalities used for this patient 6 = Androgen deprivation therapy
boolean
C0920425 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
Treatment modalities used: Focal therapy
Item
Indicate the primary treatment modalities used for this patient 7 = Focal therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Treatment modalities used: Other
Item
Indicate the primary treatment modalities used for this patient 888 = Other
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Type of focal therapy
Item
Indicate the type of focal therapy used for this patient
text
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Date watchful waiting initiated
Item
Indicate date watchful waiting initiated
date
C1298659 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date active surveillance initiated
Item
Inidicate date active surveillance initiated
date
C1827061 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of primary radical prostatectomy
Item
Indicate date of primary radical prostatectomy
date
C0194810 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate if the primary surgical approach was nerve-sparing or non-nerve-sparing
integer
C1514120 (UMLS CUI [1,1])
C1512698 (UMLS CUI [1,2])
Code List
Indicate if the primary 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)
Primary external Beam Radiation Therapy: Dose (Gray)
Item
Indicate the total dose of primary External Beam Radiation Therapy
integer
C1517033 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Primary external Beam Radiation Therapy: Average dose per fraction (Gray)
Item
Indicate the average dose per fraction of primary External Beam Radiation Therapy
float
C0860348 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264633 (UMLS CUI [1,3])
Start date of primary external beam radiation therapy
Item
Indicate start date of primary external beam radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary external beam radiation therapy
Item
Indicate stop date of primary external radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary external beam radiation therapy is ongoing
text
C1517033 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if primary external beam radiation therapy is ongoing
CL Item
Treatment ongoing (1)
C1517033 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of primary brachytherapy
Item
Indicate start date of primary brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary brachytherapy
Item
Indicate stop date of primary brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary brachytherapy is ongoing
integer
C0006098 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if primary 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])
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 primary androgen deprivation therapy
Item
Indicate start date of primary androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary androgen deprivation therapy
Item
Indicate stop date of primary androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary androgen deprivation therapy is ongoing
integer
C0279492 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if primary androgen deprivation therapy is ongoing
CL Item
Treatment ongoing (1)
C0279492 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of primary focal therapy
Item
Indicate start date of primary focal therapy
date
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of primary focal therapy
Item
Indicate stop date of primary focal therapy
date
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if primary focal therapy is ongoing
integer
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Code List
Indicate if primary focal therapy is ongoing
CL Item
Treatment ongoing (1)
C0920425 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
Primary treatment modality other than those explicitly listed
Item
Indicate the other primary treatment modality used
text
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date of other primary therapy
Item
Indicate start date of other primary therapy
date
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of other primary therapy
Item
Indicate stop date of other primary therapy
date
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if other primary therapy is ongoing
integer
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Code List
Indicate if other primary 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)
Item
Indicate whether patient experienced a Clavien grade III-V complication
integer
C0009566 (UMLS CUI [1,1])
C4055231 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial