ID

33138

Descrizione

ADVANCED PROSTATE CANCER DATA COLLECTION Version 2.3.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Conditions: All patients with advanced prostate cancer, either having metastatic disease or biochemical recurrence progressing after salvage treatment or ineligible for salvage treatment. Patients with biochemical recurrence treated with salvage therapy are referred to the localized prostate cancer set. Treatment Approaches: Hormonal Therapy | Chemotherapy | Immunotherapy | Radiopharmaceuticals | Radiation | Interventions for Complications of Local Progression This form contains clinical and administrative variables. To be assessed 1 year post (initial) treatment and annually for life from then on. Questionnaires used in this standard set: 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 (according to ICHOM). 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-C30): For use of the EORTC QLQ-C30 a license is needed, therefore the questions will not be part of this version of the standard set. (eortc.be) The following paper has been published about development of this standard set: Morgans AK, van Bommel ACM, Stowell C, Abrahm JL, Basch E, Bekelman JE, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015 Nov;68(5):891–8. For the standard set ICHOM has been supported by the Movember Foundation.

collegamento

http://www.ichom.org/

Keywords

  1. 29/11/18 29/11/18 - Sarah Riepenhausen
  2. 30/04/20 30/04/20 - Sarah Riepenhausen
Titolare del copyright

ICHOM

Caricato su

29 novembre 2018

DOI

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Licenza

Creative Commons BY-NC 3.0

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ICHOM Advanced Prostate Cancer

Follow-Up Clinical Form

Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Indicate the patient's medical record number
Descrizione

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 RESPONSE OPTIONS: According to institution

Tipo di dati

integer

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

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.

Tipo di dati

text

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

Treatment Variables

Alias
UMLS CUI-1
C0087111
Indicate if the patient received Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0279492
Indicate date patient started Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on Androgen Deprivation Therapy (ADTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Indicate date patient stopped Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on Androgen Deprivation Therapy (ADTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate if Androgen Deprivation Therapy is ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on Androgen Deprivation Therapy (ADTX), and no end date is entered (ADTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0549178
Indicate if the patient received hormonal treatment other than Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0279025
Indicate date patient started hormonal treatment other than Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on hormonal therapy (HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Indicate date patient stopped hormonal treatment other than Androgen Deprivation Therapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on hormonal therapy (HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate if hormonal therapy is ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on hormonal therapy (HORMONTX), and no end date is entered (HORMONTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0549178
Indicate if the patient received chemotherapy
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0392920
Indicate date patient started chemotherapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on chemotherapy (CHEMOTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3173309
DD/MM/YYYY
Indicate date patient stopped chemotherapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on chemotherapy (CHEMOTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate if chemotherapy is ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on chemotherapy (CHEMOTX), and no end date is entered (CHEMOTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0392920
Indicate if the patient received immunotherapy
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0021083
Indicate date patient started immunotherapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on immunotherapy (IMMUNOTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Indicate date patient stopped immunotherapy
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on immunotherapy (IMMUNOTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate if immunotherapy is ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on immunotherapy (IMMUNOTX), and no end date is entered (IMMUNOTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0549178
Indicate if the patient received radiopharmaceuticals
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0182638
Indicate date patient started radiopharmaceuticals
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on radiopharmaceuticals (RADIOPHARM) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C3173309
DD/MM/YYYY
Indicate date patient stopped radiopharmaceuticals
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on radiopharmaceuticals (RADIOPHARM) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C1531784
DD/MM/YYYY
Indicate if radiotherapy is ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on radiotherapy (RADIOTX), and no end date is entered (RADIOTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0549178
Indicate if the patient received interventions for complications due to local progression 1 = TURP (transurethral resection of the prostate)
Descrizione

Could be one of the following procedures: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C1947913
UMLS CUI [2]
C0040771
Indicate if the patient received interventions for complications due to local progression 2 = Ureteral stent
Descrizione

Could be one of the following procedures: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C1947913
UMLS CUI [2]
C0183518
Indicate if the patient received interventions for complications due to local progression 3 = Percutaneous nephrostomy tube
Descrizione

Could be one of the following procedures: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C1947913
UMLS CUI [2]
C0564457
Indicate if the patient received interventions for complications due to local progression 4 = Suprapubic catheter placement
Descrizione

Could be one of the following procedures: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C1947913
UMLS CUI [2]
C0150798
Indicate if the patient received interventions for complications due to local progression 5 = Chronic foley catheter / self intermittent catheterization
Descrizione

Could be one of the following procedures: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0178874
UMLS CUI [1,3]
C1947913
UMLS CUI [2]
C0179804
UMLS CUI [3]
C0473154
Indicate date patient received TURP intervention for complications due to for local progression
Descrizione

INCLUSION CRITERIA: All patients, If answered 'TURP' on interventions for complications due to local progression (LOCPROGTX_1) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0040771
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date patient received ureteral stent intervention for complications due to for local progression
Descrizione

INCLUSION CRITERIA: All patients, If answered 'ureteral stent' on interventions for complications due to local progression (LOCPROGTX_2) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0183518
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date patient received percutaneous nephrostomy tube intervention for complications due to for local progression
Descrizione

INCLUSION CRITERIA: All patients, If answered 'percutaneous nephrostomy tube' on interventions for complications due to local progression (LOCPROGTX_3) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0564457
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date patient received suprapubic catheter placement intervention for complications due to for local progression
Descrizione

INCLUSION CRITERIA: All patients, If answered 'suprapubic catheter placement' on interventions for complications due to local progression (LOCPROGTX_4) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0150798
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date patient received chronic foley catheter / self intermittent catheterization intervention for complications due to for local progression
Descrizione

INCLUSION CRITERIA: All patients, If answered 'chronic foley catheter / self intermittent catheterization' on interventions for complications due to local progression (LOCPROGTX_5) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0179804
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0473154
UMLS CUI [2,2]
C0011008
DD/MM/YYYY
Indicate if the patient received bisphosphonates or denosumab
Descrizione

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C1690432
Indicate date patient started bisphosphonates or denosumab
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on bisphosphonates or denosumab (BISPHOSTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C1690432
UMLS CUI [2,2]
C0808070
DD/MM/YYYY
Indicate date patient stopped bisphosphonates or denosumab
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on bisphosphonates or denosumab (BISPHOSTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1690432
UMLS CUI [2,2]
C0806020
DD/MM/YYYY
Indicate if bisphosphonates or denosumab are ongoing
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on bisphosphonates or denosumab (BISPHOSTX), and no end date is entered (BISPHOSTXSTOPDATE) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C1690432
UMLS CUI [2,2]
C0549178
Acute Complications of Treatment
Descrizione

Acute Complications of Treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0009566
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 0 = No grade III-IV toxicity
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C1515119
UMLS CUI [1,4]
C1516728
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 1 = Cytopenias (anemia, neutropenia, thrombocytopenia)
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1516728
UMLS CUI [1,4]
C0010828
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 2 = Infection, any primary site
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1516728
UMLS CUI [1,4]
C3714514
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 3 = Vomiting, diarrhea, constipation, other GI toxicity
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1516728
UMLS CUI [1,4]
C0521362
UMLS CUI [1,5]
C0013221
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 4 = Neuropathy, any type
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1516728
UMLS CUI [1,4]
C0442874
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 5 = Cardiovascular toxicity (heart attack, heart failure, arrhythmia)
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C1516728
UMLS CUI [1,4]
C0007226
UMLS CUI [1,5]
C0013221
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 888 = Other (free text)
Descrizione

A CTCAE v 4 grace III complication or higher means that the patient had to be admitted to the hospital. See http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf for a list of domains and grades of complications INCLUSION CRITERIA: Patients with systemic therapy, If answered 'yes' on chemotherapy, immunotherapy or hormonaltherapy (CHEMOTX or IMMUNOTX or HORMONTX) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C1515119
UMLS CUI [1,4]
C1516728
Indicate the CTCAE v 4.0 grade III-IV complication the patient experienced
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered 'Other' on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_888) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Free Text RESPONSE OPTIONS: CTCAE grade III-IV complication due to systemic therapy (excluding ADT)

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C1515119
UMLS CUI [1,4]
C1516728
Indicate date of cytopenias
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Cytopenias on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_1) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0010828
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date of infection
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Infection on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_2) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C2316983
DD/MM/YYYY
Indicate date of vomiting, diarrhea, constipation, or other GI toxicity
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Vomiting, diarrhea, constipation, other GI toxicity on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_3) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0521362
UMLS CUI [1,2]
C0013221
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate date of neuropathy
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Neuropathy on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_4) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate date of cardiovascular toxicity
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Cardiovascular toxicity on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_ 5) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0013221
UMLS CUI [1,3]
C2316983
DD/MM/YYYY
Indicate date of other complication
Descrizione

INCLUSION CRITERIA: Patients with systemic therapy, If answered Other on CTCAE grade III-IV complications due to systemic therapy (excluding ADT) (COMPLSYS_888) TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Degree of Health
Descrizione

Degree of Health

Alias
UMLS CUI-1
C0018759
Indicate the ECOG/WHO performance status
Descrizione

ECOG / WHO scale: - PS = 0 normal activity level; - PS = 1 restricted with strenuous activity, but can do light activity; - PS = 2 active >/= 50% of day; - PS = 3 spends >50% of day in chair or bed; - PS = 4 totally confined to bed INCLUSION CRITERIA: All patients TIMING: Baseline, 1 year post initiation of treatment, Tracked ongoing annually for life REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C1298650
Survival and disease control
Descrizione

Survival and disease control

Alias
UMLS CUI-1
C1148433
UMLS CUI-2
C0920467
Indicate if patient received any of the following procedures for local progression: 0 = None of the procedures
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0549184
Indicate if patient received any of the following procedures for local progression: 1 = TURP (transurethral resection of the prostate)
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0040771
Indicate if patient received any of the following procedures for local progression: 2 = Ureteral stent
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0183518
Indicate if patient received any of the following procedures for local progression: 3 = Percutaneous nephrostomy tube
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0564457
Indicate if patient received any of the following procedures for local progression: 4 = Suprapubic catheter placement
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0150798
Indicate if patient received any of the following procedures for local progression: 5 = Chronic foley catheter / self intermittent catheterization
Descrizione

procedures for local progression: - TURP (transurethral resection of the prostate) - Ureteral stent - Percutaneous nephrostomy tube - Suprapubic catheter placement - Chronic foley catheter / self intermittent catheterization INCLUSION CRITERIA: All patients, If answered 'yes' on procedures needed for local progression (LOCPROGTX) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Multiple Answer

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0449258
UMLS CUI [1,3]
C0179804
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0449258
UMLS CUI [2,3]
C0473154
Indicate if the patient has a symptomatic fracture, cord compression or need for surgery or radiation to bone
Descrizione

INCLUSION CRITERIA: All patients TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0153690
UMLS CUI [1,3]
C0231220
Indicate date of Symptomatic Skeletal Related Event
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on symptomatic skeletal related event (SSRE) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life, (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate if the patient was diagnosed with metastatic disease
Descrizione

INCLUSION CRITERIA: Patients without known metastasis TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Single Answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C2939420
Indicate date of metastasis
Descrizione

INCLUSION CRITERIA: Patients without known metastasis, If answered 'yes' on development of metastasis (METADEV) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
DD/MM/YYYY
Indicate if the patient was diagnosed with castration resistant disease
Descrizione

Castration-resistant disease is defined as two successive PSA rises at least one week apart, or the development or progression of radiographically proven metastatic lesions, in the setting of castrate levels of testosterone (<50 ng/mL) INCLUSION CRITERIA: Patients that are not yet castration resistant TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Single answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C3658267
Indicate date of castration-resistant disease
Descrizione

INCLUSION CRITERIA: Patients that are not yet castration resistant, If answered 'yes' on development of castration-resistant disease (CRPCDATE) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C3658267
UMLS CUI [1,2]
C2316983
DD/MM/YYYY
Indicate if the patient has died
Descrizione

INCLUSION CRITERIA: All patients TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer

Tipo di dati

integer

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

INCLUSION CRITERIA: All patients, If answered 'yes' on overall survival (OVERALLSURV) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Administrative data (Death registry) TYPE: Date by DD/MM/YYYY

Tipo di dati

date

Unità di misura
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate if death is noted to be directly attributable to prostate cancer
Descrizione

INCLUSION CRITERIA: All patients, If answered 'yes' on overall survival (OVERALLSURV) TIMING: 1 year post initiation of treatment, Tracked ongoing annually for life (when hospital is able to track this ongoing) REPORTING SOURCE: Administrative data (Death registry) TYPE: Single answer

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0596130
UMLS CUI [1,3]
C0600139

Similar models

Follow-Up Clinical Form

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (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 if the patient received Androgen Deprivation Therapy
integer
C0279492 (UMLS CUI [1])
Code List
Indicate if the patient received Androgen Deprivation Therapy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of Androgen Deprivation Therapy
Item
Indicate date patient started Androgen Deprivation Therapy
date
C0279492 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop of Androgen Deprivation Therapy
Item
Indicate date patient stopped Androgen Deprivation Therapy
date
C0279492 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if Androgen Deprivation Therapy is ongoing
integer
C0279492 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if Androgen Deprivation Therapy is ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient received hormonal treatment other than Androgen Deprivation Therapy
integer
C0279025 (UMLS CUI [1])
Code List
Indicate if the patient received hormonal treatment other than Androgen Deprivation Therapy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of hormonal therapy
Item
Indicate date patient started hormonal treatment other than Androgen Deprivation Therapy
date
C0279025 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop of hormonal therapy
Item
Indicate date patient stopped hormonal treatment other than Androgen Deprivation Therapy
date
C0279025 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if hormonal therapy is ongoing
integer
C0279025 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if hormonal therapy is ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient received chemotherapy
integer
C0392920 (UMLS CUI [1])
Code List
Indicate if the patient received chemotherapy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of chemotherapy
Item
Indicate date patient started chemotherapy
date
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Stop of chemotherapy
Item
Indicate date patient stopped chemotherapy
date
C1302181 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if chemotherapy is ongoing
integer
C0549178 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Code List
Indicate if chemotherapy is ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient received immunotherapy
integer
C0021083 (UMLS CUI [1])
Code List
Indicate if the patient received immunotherapy
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of immunotherapy
Item
Indicate date patient started immunotherapy
date
C0021083 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop of immunotherapy
Item
Indicate date patient stopped immunotherapy
date
C0021083 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if immunotherapy is ongoing
integer
C0021083 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if immunotherapy is ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient received radiopharmaceuticals
integer
C0182638 (UMLS CUI [1])
Code List
Indicate if the patient received radiopharmaceuticals
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of treatment with radiopharmaceuticals
Item
Indicate date patient started radiopharmaceuticals
date
C0182638 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Stop of treatment with radiopharmaceuticals
Item
Indicate date patient stopped radiopharmaceuticals
date
C0182638 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
Item
Indicate if radiotherapy is ongoing
integer
C0182638 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Indicate if radiotherapy is ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Interventions for complications of local progression: TURP
Item
Indicate if the patient received interventions for complications due to local progression 1 = TURP (transurethral resection of the prostate)
boolean
C0184661 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
C0040771 (UMLS CUI [2])
Interventions for complications of local progression: Ureteral Stent
Item
Indicate if the patient received interventions for complications due to local progression 2 = Ureteral stent
boolean
C0184661 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
C0183518 (UMLS CUI [2])
Interventions for complications of local progression: Percutaneous nephrostomy tube
Item
Indicate if the patient received interventions for complications due to local progression 3 = Percutaneous nephrostomy tube
boolean
C0184661 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
C0564457 (UMLS CUI [2])
Interventions for complications of local progression: Suprapubic catheter placement
Item
Indicate if the patient received interventions for complications due to local progression 4 = Suprapubic catheter placement
boolean
C0184661 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
C0150798 (UMLS CUI [2])
Interventions for complications of local progression: Chronic foley catheter / self intermittent catheterization
Item
Indicate if the patient received interventions for complications due to local progression 5 = Chronic foley catheter / self intermittent catheterization
boolean
C0184661 (UMLS CUI [1,1])
C0178874 (UMLS CUI [1,2])
C1947913 (UMLS CUI [1,3])
C0179804 (UMLS CUI [2])
C0473154 (UMLS CUI [3])
Date of TURP intervention needed for local progression
Item
Indicate date patient received TURP intervention for complications due to for local progression
date
C0040771 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of ureteral stent intervention needed for local progression
Item
Indicate date patient received ureteral stent intervention for complications due to for local progression
date
C0183518 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of percutaneous nephrostomy tube intervention needed for local progression
Item
Indicate date patient received percutaneous nephrostomy tube intervention for complications due to for local progression
date
C0564457 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of suprapubic catheter placement intervention needed for local progression
Item
Indicate date patient received suprapubic catheter placement intervention for complications due to for local progression
date
C0150798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of chronic foley catheter / self intermittent catheterization intervention needed for local progression
Item
Indicate date patient received chronic foley catheter / self intermittent catheterization intervention for complications due to for local progression
date
C0179804 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0473154 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Indicate if the patient received bisphosphonates or denosumab
integer
C0012544 (UMLS CUI [1])
C1690432 (UMLS CUI [2])
Code List
Indicate if the patient received bisphosphonates or denosumab
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of bisphosphonates or denosumab
Item
Indicate date patient started bisphosphonates or denosumab
date
C0012544 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1690432 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Stop of bisphosphonates or denosumab
Item
Indicate date patient stopped bisphosphonates or denosumab
date
C0012544 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1690432 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Indicate if bisphosphonates or denosumab are ongoing
integer
C0012544 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1690432 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Code List
Indicate if bisphosphonates or denosumab are ongoing
CL Item
Treatment ongoing (1)
C0549178 (UMLS CUI-1)
(Comment:en)
Item Group
Acute Complications of Treatment
C0087111 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): No
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 0 = No grade III-IV toxicity
boolean
C1298908 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): Cytopenia
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 1 = Cytopenias (anemia, neutropenia, thrombocytopenia)
boolean
C0009566 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0010828 (UMLS CUI [1,4])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): Infection
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 2 = Infection, any primary site
boolean
C0009566 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C3714514 (UMLS CUI [1,4])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): GI toxicity
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 3 = Vomiting, diarrhea, constipation, other GI toxicity
boolean
C0009566 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0521362 (UMLS CUI [1,4])
C0013221 (UMLS CUI [1,5])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): Neuropathy
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 4 = Neuropathy, any type
boolean
C0009566 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0442874 (UMLS CUI [1,4])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): cardiovascular toxicity
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 5 = Cardiovascular toxicity (heart attack, heart failure, arrhythmia)
boolean
C0009566 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0007226 (UMLS CUI [1,4])
C0013221 (UMLS CUI [1,5])
CTCAE grade III-IV complications due to systemic therapy (excluding ADT): other
Item
Indicate whether the patient experienced a CTCAE v 4.0 grade III-IV complication while on therapy and within 6 months after initiating treatment 888 = Other (free text)
boolean
C0205394 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
CTCAE grade III-IV complication due to systemic therapy (excluding ADT) other than those explicitly listed
Item
Indicate the CTCAE v 4.0 grade III-IV complication the patient experienced
text
C0205394 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
Date of cytopenias
Item
Indicate date of cytopenias
date
C0010828 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of infection
Item
Indicate date of infection
date
C0009450 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Date of vomiting, diarrhea, constipation, or other GI toxicity
Item
Indicate date of vomiting, diarrhea, constipation, or other GI toxicity
date
C0521362 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of neuropathy
Item
Indicate date of neuropathy
date
C0442874 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date of cardiovascular toxicity
Item
Indicate date of cardiovascular toxicity
date
C0007226 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Date of other complication
Item
Indicate date of other complication
date
C0009566 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Degree of Health
C0018759 (UMLS CUI-1)
Item
Indicate the ECOG/WHO performance status
integer
C1520224 (UMLS CUI [1,1])
C1298650 (UMLS CUI [1,2])
Code List
Indicate the ECOG/WHO performance status
CL Item
0 (0)
C1828078 (UMLS CUI-1)
(Comment:en)
CL Item
1 (1)
C1827388 (UMLS CUI-1)
(Comment:en)
CL Item
2 (2)
C1828242 (UMLS CUI-1)
(Comment:en)
CL Item
3 (3)
C1827126 (UMLS CUI-1)
(Comment:en)
CL Item
4 (4)
C1827528 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
C1520224 (UMLS CUI-2)
(Comment:en)
Item Group
Survival and disease control
C1148433 (UMLS CUI-1)
C0920467 (UMLS CUI-2)
Procedures needed for local progression: None
Item
Indicate if patient received any of the following procedures for local progression: 0 = None of the procedures
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0549184 (UMLS CUI [1,3])
Procedures needed for local progression: TURP
Item
Indicate if patient received any of the following procedures for local progression: 1 = TURP (transurethral resection of the prostate)
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0040771 (UMLS CUI [1,3])
Procedures needed for local progression: Ureteral Stent
Item
Indicate if patient received any of the following procedures for local progression: 2 = Ureteral stent
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0183518 (UMLS CUI [1,3])
Procedures needed for local progression: Percutaneous nephrostomy tube
Item
Indicate if patient received any of the following procedures for local progression: 3 = Percutaneous nephrostomy tube
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0564457 (UMLS CUI [1,3])
Procedures needed for local progression: Suprapubic catheter
Item
Indicate if patient received any of the following procedures for local progression: 4 = Suprapubic catheter placement
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0150798 (UMLS CUI [1,3])
Procedures needed for local progression: Chronic foley catheter / self intermittent catheterization
Item
Indicate if patient received any of the following procedures for local progression: 5 = Chronic foley catheter / self intermittent catheterization
boolean
C0184661 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0179804 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C0449258 (UMLS CUI [2,2])
C0473154 (UMLS CUI [2,3])
Item
Indicate if the patient has a symptomatic fracture, cord compression or need for surgery or radiation to bone
integer
C0242656 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
Code List
Indicate if the patient has a symptomatic fracture, cord compression or need for surgery or radiation to bone
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of symptomatic skeletal related event
Item
Indicate date of Symptomatic Skeletal Related Event
date
C0153690 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate if the patient was diagnosed with metastatic disease
integer
C0242656 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
Code List
Indicate if the 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)
Date of diagnosed metastasis
Item
Indicate date of metastasis
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Item
Indicate if the patient was diagnosed with castration resistant disease
integer
C0242656 (UMLS CUI [1,1])
C3658267 (UMLS CUI [1,2])
Code List
Indicate if the patient was diagnosed with castration resistant disease
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of castration-resistant disease
Item
Indicate date of castration-resistant disease
date
C3658267 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Item
Indicate if the patient has died
integer
C0011065 (UMLS CUI [1])
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])
C0596130 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Code List
Indicate if death is noted to be directly attributable to prostate cancer
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)

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