ID

31606

Beschrijving

COLORECTAL CANCER DATA COLLECTION Version 1.1.2 Revised: November 6th, 2017 http://www.ichom.org/ Conditions: All patients with newly pathologically diagnosed invasive colorectal cancer (stage I-IV) Excluded Conditions: Non-adenocarcinoma, non-primary colorectal tumors and patients with recurrent disease at baseline will be excluded. Treatment Approaches: Surgery | Radiotherapy | Chemotherapy | Targeted Therapy Forms: Baseline Patient-reported Form Baseline Clinical Form 6 Month post treatment administered Clinical Form 1 year post treatment, then annually up to 10 years administered Clinical Form Baseline, 6 months, annually up to 10 years administered patient-reported form ICHOM was supported by Alliance of Dedicated Cancer Centers (CZ, DICA, Bowel Cancer Australia) for this standard set.

Link

http://www.ichom.org/

Trefwoorden

Versies (2)
  1. 11-09-18 11-09-18 - Sarah Riepenhausen
  2. 30-04-20 30-04-20 - Sarah Riepenhausen
Houder van rechten

ICHOM

Geüploaded op

11 september 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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ICHOM Colorectal Cancer

Engels

Annual Clinical Form

1 Formulieren  
  1. StudyEvent: SE
    1. Annual Clinical Form
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 (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
Beschrijving

This Item does not exist in the original standard set. In other standard sets with multiple timepoints the following is requested to do: 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.

Datatype

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Survival and disease control
Beschrijving

Survival and disease control

Alias
UMLS CUI-1
C1148433
UMLS CUI-2
C4304384
Indicate whether there is evidence of local, regional or distant recurrence.
Beschrijving

INCLUSION CRITERIA: Only if the patient is treated with curative intent.  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, Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C0807712
DD/MM/YYYY
Indicate whether there is evidence of disease progression:
Beschrijving

INCLUSION CRITERIA: Only if the patient has advanced disease. TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0242656
Provide method of confirmation:
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0430022
Provide the date of the progression:
Beschrijving

INCLUSION CRITERIA: Only if answered "yes" on progression [PROGRESS] TIMING: 1 year post treatment, tracked annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0011008
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: Administrative TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0011065
Provide the date of the death:
Beschrijving

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

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate if death is attributable to colorectal cancer:
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1]
C0007465
Treatment Variables
Beschrijving

Treatment Variables

Alias
UMLS CUI-1
C0087111
Indicate whether the patient received one of the following treatment during the last year: (select all that apply)
Beschrijving

INCLUSION CRITERIA: All patients TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

integer

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

INCLUSION CRITERIA: If answered "surgery" on treatment [TREATMENT] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0543467
Indicate the method of the surgical procedure:
Beschrijving

INCLUSION CRITERIA: If yes answered "yes" on surgery [SURGERY] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0543467
Provide the date of surgery:
Beschrijving

INCLUSION CRITERIA: If yes answered "yes" on surgery [SURGERY] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1628561
DD/MM/YYYY
Indicate whether the patient received radiotherapy during the last year
Beschrijving

INCLUSION CRITERIA: If answered "radiotherapy" on treatment [TREATMENT] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C1522449
Indicate what type of radiotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on radiotherapy [RADIOTX] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Multiple answer

Datatype

integer

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1521902
Provide the start date of radiotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on radiotherapy [RADIOTX] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, Please enter "999" if date is unknown

Datatype

date

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

INCLUSION CRITERIA: If answered "yes" on radiotherapy [RADIOTX] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, 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 during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment [TREATMENT] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0392920
Indicate what type of chemotherapy:
Beschrijving

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

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

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, please enter "999" if date is unknown

Datatype

date

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

INCLUSION CRITERIA: If answered "chemotherapy" on treatment TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, please enter "999" if date is unknown

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 targeted therapy during the last year:
Beschrijving

INCLUSION CRITERIA: If answered "targeted therapy" on treatment [TREATMENT] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Single Answer

Datatype

integer

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

INCLUSION CRITERIA: If answered "yes on targeted therapy [TARGETTX] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, 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
Provide the stop date of targeted therapy, if applicable:
Beschrijving

INCLUSION CRITERIA: If answered "yes on targeted therapy [TARGETTX] TIMING: 6 months, update at least annually up to 10 years REPORTING SOURCE: Clinical TYPE: Date, 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
Quality of death
Beschrijving

Quality of death

Indicate where patient died as indicated on certificate of death: 
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1]
C0421611
Indicate whether patient was cared for by hospice at time of death:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually REPORTING SOURCE: Administrative or clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0085555
Indicate whether the preference for place of death was documented (the most recent documented place of death):
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0421611
UMLS CUI [1,2]
C0558295
Provide the date of documentation:
Beschrijving

INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually REPORTING SOURCE: Clinical TYPE: Date, Please enter "999" if date is unknown

Datatype

date

Maateenheden
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0920316
DD/MM/YYYY
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
Beschrijving

Emergency visits should not be included. INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0184666
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
Beschrijving

Emergency visits should not be included. INCLUSION CRITERIA: If answered "yes" on patient died [DEATH] TIMING: 1 year post treatment, tracked annually REPORTING SOURCE: Clinical TYPE: Single answer

Datatype

integer

Alias
UMLS CUI [1]
C0184666
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Similar models

Annual Clinical Form

1 Formulieren
  1. StudyEvent: SE
    1. Annual Clinical Form
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 (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Survival and disease control
C1148433 (UMLS CUI-1)
C4304384 (UMLS CUI-2)
Item
Indicate whether there is evidence of local, regional or distant recurrence.
integer
C0034897 (UMLS CUI [1])
Residual invasive cancer
Code List
Indicate whether there is evidence of local, regional or distant recurrence.
CL Item
No (0)
CL Item
Local recurrence (1)
CL Item
Unknown (999)
CL Item
Regional recurrence (2)
CL Item
Distant recurrence (3)
Item
Provide method of confirmation:
integer
C0034897 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Residual invasive cancer
Code List
Provide method of confirmation:
CL Item
Radiological diagnosis (0)
CL Item
Histological diagnosis (1)
CL Item
Unknown (999)
CL Item
Radiological and histological diagnosis (2)
Recurrence date
Item
Provide the date of the recurrence:
date
C0807712 (UMLS CUI [1])
Item
Indicate whether there is evidence of disease progression:
integer
C0242656 (UMLS CUI [1])
Disease progression
Code List
Indicate whether there is evidence of disease progression:
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (999)
Item
Provide method of confirmation:
integer
C0242656 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Disease progression
Code List
Provide method of confirmation:
CL Item
Laboratory diagnosis (0)
CL Item
Clinical diagnosis (1)
CL Item
Unknown (999)
CL Item
Radiological diagnosis (2)
CL Item
Histological diagnosis (3)
CL Item
Radiological and histological diagnosis (4)
Progression date
Item
Provide the date of the progression:
date
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate whether the patient has died
integer
C0011065 (UMLS CUI [1])
Death
Code List
Indicate whether the patient has died
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (999)
Date of death
Item
Provide the date of the death:
date
C1148348 (UMLS CUI [1])
Item
Indicate if death is attributable to colorectal cancer:
integer
C0007465 (UMLS CUI [1])
Weight units
Code List
Indicate if death is attributable to colorectal cancer:
CL Item
Yes  (1)
CL Item
No  (0)
CL Item
Unknown (999)
Item Group
Treatment Variables
C0087111 (UMLS CUI-1)
Item
Indicate whether the patient received one of the following treatment during the last year: (select all that apply)
integer
C0087111 (UMLS CUI [1])
Treatment
Code List
Indicate whether the patient received one of the following treatment during the last year: (select all that apply)
CL Item
No treatment (0)
CL Item
Surgery (1)
CL Item
Radiotherapy (2)
CL Item
Chemotherapy (3)
CL Item
Targeted therapy (4)
CL Item
Best supportive care (5)
CL Item
Unknown (999)
Item
Indicate whether the patient received surgery during the last year:
integer
C0543467 (UMLS CUI [1])
Treatment
Code List
Indicate whether the patient received surgery during the last year:
CL Item
Hemicolectomy right (1)
CL Item
Extended colectomy right (2)
CL Item
Transverse resection (3)
CL Item
Hemicolectomy left (4)
CL Item
Subtotal colectomy (5)
CL Item
Unknown (999)
CL Item
Total colectomy (6)
CL Item
Sigmoid resection (7)
CL Item
Anterior resection (8)
CL Item
Low anterior resection (LAR) (9)
CL Item
Abdomino-perineal resection (APR) (10)
CL Item
Proctectomy with coloanal (11)
CL Item
Other (12)
Item
Indicate the method of the surgical procedure:
integer
C0683312 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Treatment
Code List
Indicate the method of the surgical procedure:
CL Item
Endoscopic (for colon tumors) (1)
CL Item
Transabdominal open (2)
CL Item
Transabdominal minimally invasive (laparoscopic/robotic) (3)
CL Item
Transanal open (4)
CL Item
Transanal endoscopic (TEMS/SPTS)/minimally invasive (TAMIS) (5)
CL Item
Unknown (999)
CL Item
Other (6)
Surgery date
Item
Provide the date of surgery:
date
C1628561 (UMLS CUI [1])
Item
Indicate whether the patient received radiotherapy during the last year
integer
C1522449 (UMLS CUI [1])
Radiotherapy
Code List
Indicate whether the patient received radiotherapy during the last year
CL Item
Neoadjuvant  (1)
CL Item
Adjuvant  (2)
CL Item
Definitive (3)
CL Item
Unknown (999)
Item
Indicate what type of radiotherapy:
integer
C1522449 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Radiotherapy
Code List
Indicate what type of radiotherapy:
CL Item
Long course without chemotherapy  (1)
CL Item
Long course chemoradiation  (2)
CL Item
Brachytherapy  (3)
CL Item
Unknown (999)
CL Item
Short course  (0)
CL Item
Intraoperative radiation therapy (ORT)  (4)
CL Item
Other  (5)
Start of radiotherapy
Item
Provide the start date of radiotherapy:
date
C0436382 (UMLS CUI [1])
End of radiotherapy
Item
Provide the stop date of radiotherapy:
date
C0436385 (UMLS CUI [1])
Item
Indicate whether the patient received chemotherapy during the last year:
integer
C0392920 (UMLS CUI [1])
Chemotherapy
Code List
Indicate whether the patient received chemotherapy during the last year:
CL Item
Neoadjuvant (1)
CL Item
Adjuvant (2)
CL Item
Definitive (3)
CL Item
Unknown (999)
Item
Indicate what type of chemotherapy:
integer
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Chemotherapy
Code List
Indicate what type of chemotherapy:
CL Item
Capecitabine/oxaliplatin (1)
CL Item
Capecitabine (2)
CL Item
5-FU/leucovorin (3)
CL Item
Unknown (999)
CL Item
FOLFOX regimen (0)
CL Item
5-FU (4)
CL Item
Irinotecan (5)
CL Item
FOLFIRI (6)
CL Item
FOLFOXIRI (7)
CL Item
Uracil-tegafur (UFT)/leucovorin (8)
CL Item
Lonsurf (trifluridine and tipiracil) (9)
CL Item
Other (10)
Start of chemotherapy
Item
Provide the start date of chemotherapy:
date
C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
End of chemotherapy
Item
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 targeted therapy during the last year:
integer
C2985566 (UMLS CUI [1])
Targeted therapy
Code List
Indicate whether the patient received targeted therapy during the last year:
CL Item
Cetuximab (1)
CL Item
Bevacizumab (2)
CL Item
Panitumumab (3)
CL Item
Ramicurimab (4)
CL Item
Aflibercept (5)
CL Item
Regorafenib (6)
CL Item
Other (7)
CL Item
Unknown (999)
Start of targeted therapy
Item
Provide the start date of targeted therapy:
date
C2985566 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
End of targeted therapy
Item
Provide the stop date of targeted therapy, if applicable:
date
C2985566 (UMLS CUI [1,1])
C1531784 (UMLS CUI [1,2])
Item Group
Quality of death
Item
Indicate where patient died as indicated on certificate of death: 
integer
C0421611 (UMLS CUI [1])
Place of death
Code List
Indicate where patient died as indicated on certificate of death: 
CL Item
Home (1)
CL Item
Hospital (2)
CL Item
Nursing home/care home (including assisted living facilities) (3)
CL Item
other (4)
CL Item
Unknown (999)
Item
Indicate whether patient was cared for by hospice at time of death:
integer
C0085555 (UMLS CUI [1])
Weight units
Code List
Indicate whether patient was cared for by hospice at time of death:
CL Item
Yes  (1)
CL Item
No  (0)
CL Item
Unknown (999)
Item
Indicate whether the preference for place of death was documented (the most recent documented place of death):
integer
C0421611 (UMLS CUI [1,1])
C0558295 (UMLS CUI [1,2])
Preference of place of death
Code List
Indicate whether the preference for place of death was documented (the most recent documented place of death):
CL Item
No (0)
CL Item
Home (1)
CL Item
Hospital (2)
CL Item
Nursing home/care home (including assisted living facilities) (3)
CL Item
other (4)
CL Item
Unknown (999)
Date of documentation
Item
Provide the date of documentation:
date
C0011008 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
Item
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
integer
C0184666 (UMLS CUI [1])
Hospital admissions
Code List
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (999)
Item
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
integer
C0184666 (UMLS CUI [1])
Hospital admissions
Code List
Indicate whether the patient was admitted to the hospital > 1 time in the last 30 days of life:
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (999)
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