Follow-up_Annually - Clinical-reported

Administrative Data
Beschrijving

Administrative Data

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

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

Datatype

integer

Alias
UMLS CUI [1]
C1269815
Patient's last name:
Beschrijving

The patients' name will not be shared with ICHOM.  INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical

Datatype

text

Alias
UMLS CUI [1]
C1299487
Time Relative to Baseline
Beschrijving

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_AT (After treatment); VARIABLEID_AS (After surgery); VARIABLEID_UPDATE (Update at least annually), etc.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Tumor factors
Beschrijving

Tumor factors

Alias
UMLS CUI-1
C0475752
Indicate if the patient carries a genetic mutation predisposing breast cancer:
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Baseline and after 1 year REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0026882
Treatment variables
Beschrijving

Treatment variables

Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 0 = No treatment
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0087111
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 1 = Surgery
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0543467
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 2 = Surgery to axilla
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0004454
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 3 = Delayed reconstruction
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0085076
UMLS CUI [1,3]
C0524865
UMLS CUI [1,4]
C0205421
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 4 = Radiotherapy
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 5 = Chemotherapy
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0392920
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 6 = Hormonal therapy
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0279025
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 7 = Targeted therapy
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2985566
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 8 = Best supportive care
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0344211
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 999 = Unknown
Beschrijving

INCLUSION CRITERIA: All patients TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answers

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439673
Indicate whether the patient received surgery during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "surgery" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C4086728
Provide the date of surgery:
Beschrijving

INCLUSION CRITERIA: If answered "surgery" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1624150
DD/MM/YYYY
Indicate whether the patient received surgery to the axilla during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "surgery to axilla" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C1624150
UMLS CUI [1,2]
C4086728
Please provide the date of surgery to the axilla (DD/MM/YYYY):
Beschrijving

INCLUSION CRITERIA: If answered "surgery to axilla" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0004454
UMLS CUI [1,2]
C1624150
DD/MM/YYYY
Indicate whether the patient received axillary clearance due to lymph node involvement after sentinel lymph node biopsy during the last year:
Beschrijving

INCLUSION CRITERIA: If answered " sentinel lymph node biopsy" or "axillary sampling on surgery axilla [SURGERYAX] [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0337383
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C4086728
Please provide the date of axillary clearance (DD/MM/YYYY):
Beschrijving

INCLUSION CRITERIA: If answered "yes" on axillary clearance [SURGERYAX2] IMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0337383
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate whether the patient received a delayed reconstruction during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "delayed reconstruction" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0085076
UMLS CUI [1,2]
C4086728
Please provide the date of delayed reconstruction (DD/MM/YYYY):
Beschrijving

INCLUSION CRITERIA: If "yes" on reconstruction TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085076
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate whether the patient received radiotherapy during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C4086728
Indicate location/type of radiotherapy: 0 = Breast
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0006141
Indicate location/type of radiotherapy: 1 = Chest wall
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0205076
Indicate location/type of radiotherapy: 2 = Axillary nodal irradiation
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0729594
Indicate location/type of radiotherapy: 3 = Supraclavicular irradiation
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0589496
Indicate location/type of radiotherapy: 4 = Internal mammary node irradiation
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0229755
Indicate location/type of radiotherapy: 5 = Tumor bed boost
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C3640144
UMLS CUI [2,2]
C1511253
Indicate location/type of radiotherapy: 6 = Brain metastases
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0220650
Indicate location/type of radiotherapy: 7 = Bone metastases
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0153690
Indicate location/type of radiotherapy: 8 = Any metastatic site
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0280457
Indicate location/type of radiotherapy: 9 = Other
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0205394
Indicate location/type of radiotherapy: 999 = Unknown
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0439673
Please provide the start date of radiotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C0436382
DD/MM/YYYY
Please provide the stop date of radiotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C0436385
DD/MM/YYYY
Indicate whether the patient received chemotherapy neoadjuvant or adjuvant:
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0392920
Indicate what type of chemotherapy (select all that apply) 0 = Anthracycline containing
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0282564
Indicate what type of chemotherapy (select all that apply) 1 = Taxane containing
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0215136
Indicate what type of chemotherapy (select all that apply) 2 = Platinum containing
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0032207
Indicate what type of chemotherapy (select all that apply) 3 = Other
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0205394
Indicate what type of chemotherapy (select all that apply) 999 = Unknown
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0439673
Please provide the start date of chemotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C3173309
DD/MM/YYYY
Please provide the stop date of chemotherapy, if applicable:
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: Update at least annually REPORTING SOURCE: Clinical

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate whether the patient received hormonal therapy neoadjuvant or adjuvant:
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1]
C0279025
Indicate what type of hormonal therapy (select all that apply) 0 = Aromatase inhibitor
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0593802
Indicate what type of hormonal therapy (select all that apply) 1 = Selective estrogen-receptor modulator (e.g. Tamoxifen)
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0732611
UMLS CUI [3]
C0039286
Indicate what type of hormonal therapy (select all that apply) 2 = Oophorectomy
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0029936
Indicate what type of hormonal therapy (select all that apply) 3 = LHRH agonist
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C1518041
Indicate what type of hormonal therapy (select all that apply) 4 = Other
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0205394
Indicate what type of hormonal therapy (select all that apply) 999 = Unknown
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Multiple answer Separate multiple entries with "";""

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332307
UMLS CUI [2]
C0439673
Please provide the start date of hormonal therapy:
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0808070
DD/MM/YYYY
Please provide the stop date of hormonal therapy, if applicable:
Beschrijving

INCLUSION CRITERIA: If answered "hormonal therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0806020
DD/MM/YYYY
Indicate what type of targeted therapy:
Beschrijving

INCLUSION CRITERIA: If answered "targeted therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C2985566
Please provide the start date of targeted therapy:
Beschrijving

INCLUSION CRITERIA: If answered "targeted therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C3173309
DD/MM/YYYY
Please provide the stop date of targeted therapy, if applicable:
Beschrijving

INCLUSION CRITERIA: If answered "targeted therapy" on treatment [TREATMENT] TIMING: Update at least annually REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C1531784
DD/MM/YYYY
Disutility of care
Beschrijving

Disutility of care

Indicate if the patient has undergone a reoperation due to involved margins after primary surgery:
Beschrijving

INCLUSION CRITERIA: Only if the patient received surgery/radiotherapy. TIMING: Update at least 6 months after treatment REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0229985
Please provide the date of the reoperation due to positive margins:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on reoperation [REOP] TIMING: Update at least 6 months after treatment REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0558347
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  0 = No
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0009566
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  1 = Complication requiring intervention (surgical, radiological, endoscopic)
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0205483
UMLS CUI [5]
C0014245
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  2 = Complication leading to prolonged hospitalization ( >14days)
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0745041
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  3 = Complication leading to unplanned readmission
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2,1]
C0030700
UMLS CUI [2,2]
C3854240
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  4 = Complication leading to ICU admission
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0583239
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  5 = Complication leading to discontinuing of treatment
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2,1]
C1444662
UMLS CUI [2,2]
C0087111
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  6 = Complication leading to reduced dosing
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C1707814
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  7 = Complication leading to death
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0011065
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  8 = Complication, but did not result in any of the abovementioned
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0009566
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  999 = Unknown
Beschrijving

These response options are based on the Clavien-Dindo classification for surgical complications and the Common Terminology Criteria version 4 (CTCAE v4). To collect the most severe complications, grade 3 -5 of both classification systems are included in the Standard Set. INCLUSION CRITERIA: Only if the patient received treatment. TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Multiple Answer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0439673
Please provide the date of death:
Beschrijving

INCLUSION CRITERIA: If answered "Complication leading to death" on experience of complication [COMPLIMPACT] TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0009566
DD/MM/YYYY
Indicate whether the complication is attributable to breast cancer treatment:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on experience of complication [COMPLIMPACT] TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0596130
UMLS CUI [1,3]
C0920425
Please indicate the type of complication:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on complication attributable to breast cancer treatment [COMPLTX] TIMING: Updated at least 6 months after treatment completion, except for patients with hormonal therapy which will be updated at least 6 months and 1 year after treatment initiation REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1]
C3258281
Survival and Disease control
Beschrijving

Survival and Disease control

Indicate whether there is evidence of local, regional or distant recurrence.
Beschrijving

INCLUSION CRITERIA: Only if the intent of treatment is curative   TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1]
C0034897
Provide method of confirmation:
Beschrijving

INCLUSION CRITERIA: Only if answered "yes" on recurrence [RECUR] TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0332307
Provide the date of the recurrence:
Beschrijving

INCLUSION CRITERIA: Only if answered "yes" on recurrence [RECUR] TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C0807712
DD/MM/YYYY
Indicate whether the patient has died
Beschrijving

INCLUSION CRITERIA: All patients TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

Alias
UMLS CUI [1]
C0011065
Indicate whether the patient has died
Beschrijving

INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY; Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate whether the patient has died
Beschrijving

INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0596130
UMLS CUI [1,3]
C0678222

Similar models

Follow-up_Annually - Clinical-reported

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Patient's last name
Item
Patient's last name:
text
C1299487 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Tumor factors
C0475752 (UMLS CUI-1)
Item
Indicate if the patient carries a genetic mutation predisposing breast cancer:
integer
C0026882 (UMLS CUI [1])
Code List
Indicate if the patient carries a genetic mutation predisposing breast cancer:
CL Item
No mutation (0)
C1298908 (UMLS CUI-1)
C0026882 (UMLS CUI-2)
(Comment:en)
CL Item
BRCA 1 (1)
C1511022 (UMLS CUI-1)
(Comment:en)
CL Item
BRCA 2 (2)
C1511024 (UMLS CUI-1)
(Comment:en)
CL Item
Other mutation (3)
C0205394 (UMLS CUI-1)
C0026882 (UMLS CUI-2)
(Comment:en)
CL Item
Not tested (4)
C3640292 (UMLS CUI-1)
(Comment:en)
Item Group
Treatment variables
Treatment: No
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 0 = No treatment
boolean
C1298908 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment: Surgery
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 1 = Surgery
boolean
C0087111 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Treatment: Surgery to axilla
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 2 = Surgery to axilla
boolean
C0087111 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0004454 (UMLS CUI [1,3])
Treatment: Delayed reconstruction
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 3 = Delayed reconstruction
boolean
C0087111 (UMLS CUI [1,1])
C0085076 (UMLS CUI [1,2])
C0524865 (UMLS CUI [1,3])
C0205421 (UMLS CUI [1,4])
Treatment: Radiotherapy
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 4 = Radiotherapy
boolean
C1522449 (UMLS CUI [1])
Treatment: Chemotherapy
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 5 = Chemotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Treatment: Hormonal therapy
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 6 = Hormonal therapy
boolean
C0087111 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Treatment: Targeted therapy
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 7 = Targeted therapy
boolean
C0087111 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Treatment: Best supportive care
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 8 = Best supportive care
boolean
C0087111 (UMLS CUI [1,1])
C0344211 (UMLS CUI [1,2])
Treatment: Unknown
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply) 999 = Unknown
boolean
C0087111 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item
Indicate whether the patient received surgery during the last year:
integer
C0543467 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Code List
Indicate whether the patient received surgery during the last year:
CL Item
Breast conserving surgery (BCS) (0)
C0917927 (UMLS CUI-1)
(Comment:en)
CL Item
BCS with mammoplasty  (1)
C0917927 (UMLS CUI-1)
C0085076 (UMLS CUI-2)
(Comment:en)
CL Item
Mastectomy without immediate reconstruction (2)
C0024881 (UMLS CUI-1)
C0332288 (UMLS CUI-2)
C0085076 (UMLS CUI-3)
(Comment:en)
CL Item
Mastectomy with immediate reconstruction (direct/staged implant) (3)
C0024881 (UMLS CUI-1)
C0332283 (UMLS CUI-2)
C0085076 (UMLS CUI-3)
C0021102 (UMLS CUI-4)
(Comment:en)
CL Item
Mastectomy with immediate reconstruction (autologous) (4)
C0024881 (UMLS CUI-1)
C0332283 (UMLS CUI-2)
C0085076 (UMLS CUI-3)
C0439859 (UMLS CUI-4)
(Comment:en)
CL Item
Mastectomy with immediate reconstruction (direct/staged implant and autologous) (5)
C0024881 (UMLS CUI-1)
C0332283 (UMLS CUI-2)
C0085076 (UMLS CUI-3)
C0021102 (UMLS CUI-4)
C0439859 (UMLS CUI-5)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Surgery date
Item
Provide the date of surgery:
date
C1624150 (UMLS CUI [1])
Item
Indicate whether the patient received surgery to the axilla during the last year:
integer
C1624150 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Code List
Indicate whether the patient received surgery to the axilla during the last year:
CL Item
Sentinel lymph node biopsy (0)
C0796693 (UMLS CUI-1)
(Comment:en)
CL Item
Axillary sampling (1)
C0004454 (UMLS CUI-1)
C0441621 (UMLS CUI-2)
(Comment:en)
CL Item
Axillary clearance (2)
C0337383 (UMLS CUI-1)
C0729594 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Surgery axilla date
Item
Please provide the date of surgery to the axilla (DD/MM/YYYY):
date
C0004454 (UMLS CUI [1,1])
C1624150 (UMLS CUI [1,2])
Item
Indicate whether the patient received axillary clearance due to lymph node involvement after sentinel lymph node biopsy during the last year:
integer
C0337383 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C4086728 (UMLS CUI [1,3])
Code List
Indicate whether the patient received axillary clearance due to lymph node involvement after sentinel lymph node biopsy during the last year:
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Axillary clearance date
Item
Please provide the date of axillary clearance (DD/MM/YYYY):
date
C0337383 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate whether the patient received a delayed reconstruction during the last year:
integer
C0085076 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Code List
Indicate whether the patient received a delayed reconstruction during the last year:
CL Item
Delayed reconstruction (direct/staged implant) (0)
C0021102 (UMLS CUI-1)
(Comment:en)
CL Item
Delayed reconstruction ( autologous) (1)
C0439859 (UMLS CUI-1)
(Comment:en)
CL Item
Delayed reconstruction (implant/autologous) (2)
C0021102 (UMLS CUI-1)
C0439859 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Reconstruction date
Item
Please provide the date of delayed reconstruction (DD/MM/YYYY):
date
C0085076 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate whether the patient received radiotherapy during the last year:
integer
C1522449 (UMLS CUI [1,1])
C4086728 (UMLS CUI [1,2])
Code List
Indicate whether the patient received radiotherapy during the last year:
CL Item
Neoadjuvant (0)
C1298676 (UMLS CUI-1)
(Comment:en)
CL Item
Adjuvant (1)
C1298675 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Radiotherapy type
Item
Indicate location/type of radiotherapy: 0 = Breast
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0006141 (UMLS CUI [2])
Radiotherapy type: Chest wall
Item
Indicate location/type of radiotherapy: 1 = Chest wall
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205076 (UMLS CUI [2])
Radiotherapy type: Axillary nodal irradiation
Item
Indicate location/type of radiotherapy: 2 = Axillary nodal irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0729594 (UMLS CUI [2])
Radiotherapy type: Supraclavicular irradiation
Item
Indicate location/type of radiotherapy: 3 = Supraclavicular irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0589496 (UMLS CUI [2])
Radiotherapy type: Internal mammary node irradiation
Item
Indicate location/type of radiotherapy: 4 = Internal mammary node irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0229755 (UMLS CUI [2])
Radiotherapy type: Tumor bed boost
Item
Indicate location/type of radiotherapy: 5 = Tumor bed boost
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3640144 (UMLS CUI [2,1])
C1511253 (UMLS CUI [2,2])
Radiotherapy type: Brain metastases
Item
Indicate location/type of radiotherapy: 6 = Brain metastases
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Radiotherapy type: Bone metastases
Item
Indicate location/type of radiotherapy: 7 = Bone metastases
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
Radiotherapy type: Any metastatic site
Item
Indicate location/type of radiotherapy: 8 = Any metastatic site
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0280457 (UMLS CUI [2])
Radiotherapy type: Other
Item
Indicate location/type of radiotherapy: 9 = Other
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Radiotherapy type: Unknown
Item
Indicate location/type of radiotherapy: 999 = Unknown
boolean
C1522449 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2])
Start of radiotherapy
Item
Please provide the start date of radiotherapy:
date
C0436382 (UMLS CUI [1])
End of radiotherapy
Item
Please provide the stop date of radiotherapy:
date
C0436385 (UMLS CUI [1])
Item
Indicate whether the patient received chemotherapy neoadjuvant or adjuvant:
integer
C0392920 (UMLS CUI [1])
Code List
Indicate whether the patient received chemotherapy neoadjuvant or adjuvant:
CL Item
Neoadjuvant (0)
C1298676 (UMLS CUI-1)
(Comment:en)
CL Item
Adjuvant (1)
C1298675 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Type of chemotherapy: Anthracycline containing
Item
Indicate what type of chemotherapy (select all that apply) 0 = Anthracycline containing
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
Type of chemotherapy: Taxane containing
Item
Indicate what type of chemotherapy (select all that apply) 1 = Taxane containing
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2])
Type of chemotherapy: Platinum containing
Item
Indicate what type of chemotherapy (select all that apply) 2 = Platinum containing
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0032207 (UMLS CUI [2])
Type of chemotherapy: Other
Item
Indicate what type of chemotherapy (select all that apply) 3 = Other
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Type of chemotherapy: Unknown
Item
Indicate what type of chemotherapy (select all that apply) 999 = Unknown
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2])
Start of chemotherapy
Item
Please provide the start date of chemotherapy:
date
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
End of chemotherapy
Item
Please provide the stop date of chemotherapy, if applicable:
date
C1302181 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate whether the patient received hormonal therapy neoadjuvant or adjuvant:
integer
C0279025 (UMLS CUI [1])
Code List
Indicate whether the patient received hormonal therapy neoadjuvant or adjuvant:
CL Item
Neoadjuvant (0)
C1298676 (UMLS CUI-1)
(Comment:en)
CL Item
Adjuvant (1)
C1298675 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Hormonal therapy type: Aromatase inhibitor
Item
Indicate what type of hormonal therapy (select all that apply) 0 = Aromatase inhibitor
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2])
Hormonal therapy type: Selective estrogen-receptor modulator
Item
Indicate what type of hormonal therapy (select all that apply) 1 = Selective estrogen-receptor modulator (e.g. Tamoxifen)
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0732611 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
Hormonal therapy type: Oophorectomy
Item
Indicate what type of hormonal therapy (select all that apply) 2 = Oophorectomy
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0029936 (UMLS CUI [2])
Hormonal therapy type: LHRH agonist
Item
Indicate what type of hormonal therapy (select all that apply) 3 = LHRH agonist
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518041 (UMLS CUI [2])
Hormonal therapy type: Other
Item
Indicate what type of hormonal therapy (select all that apply) 4 = Other
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Hormonal therapy type: Unknown
Item
Indicate what type of hormonal therapy (select all that apply) 999 = Unknown
boolean
C0279025 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0439673 (UMLS CUI [2])
Start of hormonal therapy
Item
Please provide the start date of hormonal therapy:
date
C0279025 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop of hormonal therapy
Item
Please provide the stop date of hormonal therapy, if applicable:
date
C0279025 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate what type of targeted therapy:
integer
C2985566 (UMLS CUI [1])
Code List
Indicate what type of targeted therapy:
CL Item
Her-2 targeting therapy (0)
C1512413 (UMLS CUI-1)
C2985566 (UMLS CUI-2)
(Comment:en)
CL Item
Other (1)
C0205394 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start of targeted therapy
Item
Please provide the start date of targeted therapy:
date
C2985566 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
Stop of targeted therapy
Item
Please provide the stop date of targeted therapy, if applicable:
date
C2985566 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
Item Group
Disutility of care
Item
Indicate if the patient has undergone a reoperation due to involved margins after primary surgery:
integer
C1314939 (UMLS CUI [1,1])
C0229985 (UMLS CUI [1,2])
Code List
Indicate if the patient has undergone a reoperation due to involved margins after primary surgery:
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, breast conserving therapy (1)
C0917927 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, mastectomy (2)
C0024881 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Positive margins reoperation date
Item
Please provide the date of the reoperation due to positive margins:
date
C0558347 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Complications: No
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  0 = No
boolean
C1298908 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Complications: Complication requiring intervention
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  1 = Complication requiring intervention (surgical, radiological, endoscopic)
boolean
C0009566 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0205483 (UMLS CUI [4])
C0014245 (UMLS CUI [5])
Complications: leading to prolonged hospitalization
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  2 = Complication leading to prolonged hospitalization ( >14days)
boolean
C0009566 (UMLS CUI [1])
C0745041 (UMLS CUI [2])
Complications: unplanned readmission
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  3 = Complication leading to unplanned readmission
boolean
C0009566 (UMLS CUI [1])
C0030700 (UMLS CUI [2,1])
C3854240 (UMLS CUI [2,2])
Complications: ICU admission
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  4 = Complication leading to ICU admission
boolean
C0009566 (UMLS CUI [1])
C0583239 (UMLS CUI [2])
Complications: discontinuing of treatment
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  5 = Complication leading to discontinuing of treatment
boolean
C0009566 (UMLS CUI [1])
C1444662 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Complications: reduced dosing
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  6 = Complication leading to reduced dosing
boolean
C0009566 (UMLS CUI [1])
C1707814 (UMLS CUI [2])
Complications: death
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  7 = Complication leading to death
boolean
C0009566 (UMLS CUI [1])
C0011065 (UMLS CUI [2])
Complications, did not result in any of the abovementioned
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  8 = Complication, but did not result in any of the abovementioned
boolean
C0205394 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Complications: Unknown
Item
Indicate whether the patient experienced a complication while on treatment or 90 days following treatment (multiple answers possible):  999 = Unknown
boolean
C0009566 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Death of complication
Item
Please provide the date of death:
date
C0007465 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
Item
Indicate whether the complication is attributable to breast cancer treatment:
integer
C0009566 (UMLS CUI [1,1])
C0596130 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Code List
Indicate whether the complication is attributable to breast cancer treatment:
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Please indicate the type of complication:
integer
C3258281 (UMLS CUI [1])
Code List
Please indicate the type of complication:
CL Item
Wound infection (0)
C0043241 (UMLS CUI-1)
(Comment:en)
CL Item
Seroma/hematoma (1)
C0018944 (UMLS CUI-1)
(Comment:en)
CL Item
Hemorrhage (2)
C0019080 (UMLS CUI-1)
(Comment:en)
CL Item
Mastectomy skin flap necrosis (3)
C0024881 (UMLS CUI-1)
C0151799 (UMLS CUI-2)
(Comment:en)
CL Item
Partial autologous graft loss (4)
C0728938 (UMLS CUI-1)
C0439859 (UMLS CUI-2)
C0877042 (UMLS CUI-3)
C0728938 (UMLS CUI-4)
(Comment:en)
CL Item
Total autologous graft loss (5)
C0439810 (UMLS CUI-1)
C0439859 (UMLS CUI-2)
C0877042 (UMLS CUI-3)
(Comment:en)
CL Item
Loss of implant (6)
C0021102 (UMLS CUI-1)
C1517945 (UMLS CUI-2)
(Comment:en)
CL Item
Thromboembolic event (7)
C0040038 (UMLS CUI-1)
(Comment:en)
CL Item
Nerve damage (8)
C0161479 (UMLS CUI-1)
(Comment:en)
CL Item
Delay wound healing/dehiscence (9)
C0259768 (UMLS CUI-1)
(Comment:en)
CL Item
Skin toxicity (10)
C1167791 (UMLS CUI-1)
(Comment:en)
CL Item
Pneumonia (11)
C0032285 (UMLS CUI-1)
(Comment:en)
CL Item
Neutropenic sepsis (12)
C0853697 (UMLS CUI-1)
C0243026 (UMLS CUI-2)
(Comment:en)
CL Item
unkown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item Group
Survival and Disease control
Item
Indicate whether there is evidence of local, regional or distant recurrence.
integer
C0034897 (UMLS CUI [1])
Code List
Indicate whether there is evidence of local, regional or distant recurrence.
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, local recurrence (1)
C0027643 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, regional recurrence (2)
C0521158 (UMLS CUI-1)
C0205147 (UMLS CUI-2)
(Comment:en)
CL Item
Yes, distant recurrence (3)
C0521158 (UMLS CUI-1)
C0443203 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Provide method of confirmation:
integer
C0034897 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Provide method of confirmation:
CL Item
Radiological diagnosis (0)
C0043299 (UMLS CUI-1)
(Comment:en)
CL Item
Histological diagnosis (1)
C0679557 (UMLS CUI-1)
(Comment:en)
CL Item
Radiological and histological diagnosis (2)
C0043299 (UMLS CUI-1)
C0679557 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (3)
C0439673 (UMLS CUI-1)
(Comment:en)
Recurrence date
Item
Provide the date of the recurrence:
date
C0807712 (UMLS CUI [1])
Item
Indicate whether the patient has died
integer
C0011065 (UMLS CUI [1])
Code List
Indicate whether the patient has died
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Date of death
Item
Indicate whether the patient has died
date
C1148348 (UMLS CUI [1])
Item
Indicate whether the patient has died
integer
C0007465 (UMLS CUI [1,1])
C0596130 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Code List
Indicate whether the patient has died
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)