Baseline Clinical Form

1 forms
  1. StudyEvent: ODM
    1. Baseline Clinical Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Item Group
Demographic Factors
C1704791 (UMLS CUI-1)
Date of birth
Item
What is your date of birth?
date
C0421451 (UMLS CUI [1])
Height
Item
Indicate height in centimeters or inches
float
C0005890 (UMLS CUI [1])
Item
Indicate units of height
integer
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Height units
Code List
Indicate units of height
CL Item
centimeters (1)
C0475210 (UMLS CUI-1)
(Comment:en)
CL Item
inches (2)
C0439204 (UMLS CUI-1)
(Comment:en)
Weight
Item
Indicate weight in kilograms or pounds
float
C0005910 (UMLS CUI [1])
Item
Indicate units of weight
integer
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Pathological tumor stage
Code List
Indicate units of weight
CL Item
kilograms (1)
C0439209 (UMLS CUI-1)
(Comment:en)
CL Item
pounds (2)
C0439219 (UMLS CUI-1)
(Comment:en)
Item Group
Baseline Clinical Factors
C0449440 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Hemoglobin level at APC diagnosis
Item
Indicate hemoglobin level at time of APC diagnosis
float
C0518015 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item Group
Baseline Tumor Factors
C0475752 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
PSA level at APC diagnosis
Item
Indicate PSA value at time of APC diagnosis
float
C0201544 (UMLS CUI [1])
Item
Indicate the clinical tumor stage (per AJCC 7th)
integer
C0600139 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Clinical tumor stage
Code List
Indicate the clinical tumor stage (per AJCC 7th)
CL Item
cT0  (0)
C1275863 (UMLS CUI-1)
C0475371 (UMLS CUI-2)
(Comment:en)
CL Item
cT1 (1)
C1275863 (UMLS CUI-1)
C0475372 (UMLS CUI-2)
(Comment:en)
CL Item
cT1a (2)
C1275863 (UMLS CUI-1)
C0475383 (UMLS CUI-2)
(Comment:en)
CL Item
cT1b (3)
C1275863 (UMLS CUI-1)
C0475385 (UMLS CUI-2)
(Comment:en)
CL Item
cT1c (4)
C1275863 (UMLS CUI-1)
C0475386 (UMLS CUI-2)
(Comment:en)
CL Item
cT2  (5)
C1275863 (UMLS CUI-1)
C0475373 (UMLS CUI-2)
(Comment:en)
CL Item
cT2a (6)
C1275863 (UMLS CUI-1)
C0475387 (UMLS CUI-2)
(Comment:en)
CL Item
cT2b  (7)
C1275863 (UMLS CUI-1)
C0475387 (UMLS CUI-2)
(Comment:en)
CL Item
cT2c  (8)
C1275863 (UMLS CUI-1)
C0475389 (UMLS CUI-2)
(Comment:en)
CL Item
cT3  (9)
C1275863 (UMLS CUI-1)
C0475374 (UMLS CUI-2)
(Comment:en)
CL Item
cT3a (10)
C1275863 (UMLS CUI-1)
C0475390 (UMLS CUI-2)
(Comment:en)
CL Item
cT3b (11)
C1275863 (UMLS CUI-1)
C0475391 (UMLS CUI-2)
(Comment:en)
CL Item
cT4 (12)
C1275863 (UMLS CUI-1)
C0475751 (UMLS CUI-2)
(Comment:en)
CL Item
cTX (13)
C1275863 (UMLS CUI-1)
C0332377 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C1275863 (UMLS CUI-1)
C0439673 (UMLS CUI-2)
(Comment:en)
Item
Indicate the clinical nodal stage (per AJCC 7th)
integer
C0600139 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Clinical nodal stage
Code List
Indicate the clinical nodal stage (per AJCC 7th)
CL Item
N0  (0)
C1275865 (UMLS CUI-1)
C0441959 (UMLS CUI-2)
(Comment:en)
CL Item
N1  (1)
C1275865 (UMLS CUI-1)
C0441962 (UMLS CUI-2)
(Comment:en)
CL Item
NX  (2)
C1275865 (UMLS CUI-1)
C0445085 (UMLS CUI-2)
(Comment:en)
CL Item
Unknown (999)
C1275865 (UMLS CUI-1)
C0439673 (UMLS CUI-2)
(Comment:en)
Item
Indicate the pathological tumor stage (per AJCC 7th)
integer
C0600139 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C1521733 (UMLS CUI [1,3])
Pathological tumor stage
Code List
Indicate the pathological tumor stage (per AJCC 7th)
CL Item
pT2  (1)
C0332392 (UMLS CUI-1)
(Comment:en)
CL Item
pT2a  (2)
C2732270 (UMLS CUI-1)
(Comment:en)
CL Item
pT2b  (3)
C2733080 (UMLS CUI-1)
(Comment:en)
CL Item
pT2c  (4)
C2733081 (UMLS CUI-1)
(Comment:en)
CL Item
pT3 (5)
C0332393 (UMLS CUI-1)
(Comment:en)
CL Item
pT3a  (6)
C2733390 (UMLS CUI-1)
(Comment:en)
CL Item
pT3b  (7)
C2732522 (UMLS CUI-1)
(Comment:en)
CL Item
pT4  (8)
C0332394 (UMLS CUI-1)
(Comment:en)
CL Item
pTX (9)
C0332395 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
C1272834 (UMLS CUI-2)
(Comment:en)
Item
Indicate the pathological nodal stage (per AJCC 7th)
integer
C0600139 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
C1521733 (UMLS CUI [1,3])
Pathological nodal stage
Code List
Indicate the pathological nodal stage (per AJCC 7th)
CL Item
pN0  (0)
C0332396 (UMLS CUI-1)
(Comment:en)
CL Item
pN1 (1)
C0332397 (UMLS CUI-1)
(Comment:en)
CL Item
pNX (2)
C0332401 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
C1272833 (UMLS CUI-2)
(Comment:en)
Item
Indicate if a Gleason score was recorded at time of initial diagnosis
integer
C0332326 (UMLS CUI [1])
Pathological nodal stage
Code List
Indicate if a Gleason score was recorded at time of initial diagnosis
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)
Gleason score at time of initial diagnosis: Primary
Item
If yes, indicate the primary Gleason score at time of initial diagnosis
integer
C0332326 (UMLS CUI [1,1])
C1273604 (UMLS CUI [1,2])
Gleason score at time of initial diagnosis: Secondary
Item
If yes, indicate the secondary Gleason score at time of initial diagnosis
integer
C0332326 (UMLS CUI [1,1])
C1273605 (UMLS CUI [1,2])
Item
Provide site of metastatic disease
integer
C0807944 (UMLS CUI [1])
Site of metastatic disease
Code List
Provide site of metastatic disease
CL Item
No metastasis (0)
C0027627 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
CL Item
Bone only (1)
C0153690 (UMLS CUI-1)
C0205171 (UMLS CUI-2)
(Comment:en)
CL Item
Lymph node only (2)
C0806692 (UMLS CUI-1)
C0205171 (UMLS CUI-2)
(Comment:en)
CL Item
Visceral only (3)
C0027627 (UMLS CUI-1)
C0442045 (UMLS CUI-2)
C0205171 (UMLS CUI-3)
(Comment:en)
CL Item
Combination (4)
C0205195 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
(Comment:en)
Item
Provide extent of metastatic disease
integer
C0449279 (UMLS CUI [1])
Extent of metastatic disease
Code List
Provide extent of metastatic disease
CL Item
No metastasis (0)
C0027627 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
CL Item
Low burden (1)
C0027627 (UMLS CUI-1)
C1449699 (UMLS CUI-2)
C0205251 (UMLS CUI-3)
(Comment:en)
CL Item
High burden (2)
C0027627 (UMLS CUI-1)
C1449699 (UMLS CUI-2)
C0205250 (UMLS CUI-3)
(Comment:en)
Item Group
Treatment Factors
C0679853 (UMLS CUI-1)
Item
Indicate if the patient has had a prior prostatectomy
integer
C1514463 (UMLS CUI [1,1])
C0033573 (UMLS CUI [1,2])
Question 2 of additional libido and use of sexual aids questions
Code List
Indicate if the patient has had a prior prostatectomy
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of prior prostatectomy
Item
Indicate date of prostatectomy
date
C1514463 (UMLS CUI [1,1])
C0033573 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate if the patient has had prior radiation as primary treatment for prostate cancer (prostate bed, not palliative radiation)
integer
C0279134 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
Prior radiation therapy: Primary treatment
Code List
Indicate if the patient has had prior radiation as primary treatment for prostate cancer (prostate bed, not palliative radiation)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, 1-3 years ago (1)
C3843820 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, > 3 years ago (2)
C3843819 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient has had prior radiation as adjuvant / salvage therapy for prostate cancer (prostate bed, not palliative radiation)
integer
C0279134 (UMLS CUI [1,1])
C1706721 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0085405 (UMLS CUI [2,2])
Prior radiation therapy: Primary treatment
Code List
Indicate if the patient has had prior radiation as adjuvant / salvage therapy for prostate cancer (prostate bed, not palliative radiation)
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, 1-3 years ago (1)
C3843820 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, > 3 years ago (2)
C3843819 (UMLS CUI-1)
(Comment:en)
Item
Indicate if the patient has had treatment with ADT
integer
C0279492 (UMLS CUI [1])
Prior radiation therapy: Primary treatment
Code List
Indicate if the patient has had treatment with ADT
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, with bilateral orchiectomies (1)
C1705108 (UMLS CUI-1)
C3698192 (UMLS CUI-2)
(Comment:en)
CL Item
Yes, with LHRH or GnRH agonist or antagonist in the past (2)
C1705108 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1518041 (UMLS CUI-3)
C0023610 (UMLS CUI-4)
C0003139 (UMLS CUI-5)
C2267073 (UMLS CUI-6)
C1268855 (UMLS CUI-7)
(Comment:en)
CL Item
Yes, with LHRH or GnRH agonist or antagonist currently (3)
C1705108 (UMLS CUI-1)
C0521116 (UMLS CUI-2)
C1518041 (UMLS CUI-3)
C0023610 (UMLS CUI-4)
C0003139 (UMLS CUI-5)
C2267073 (UMLS CUI-6)
C1268855 (UMLS CUI-7)
(Comment:en)
Item
Indicate systemic therapies used in the past other than ADT
integer
C1515119 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Prior radiation therapy: Primary treatment
Code List
Indicate systemic therapies used in the past other than ADT
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, 1 therapy used (1)
C1705108 (UMLS CUI-1)
C1515119 (UMLS CUI-2)
C0205447 (UMLS CUI-3)
(Comment:en)
CL Item
Yes, 2 therapies used (2)
C1705108 (UMLS CUI-1)
C1515119 (UMLS CUI-2)
C0205448 (UMLS CUI-3)
(Comment:en)
CL Item
Yes, ≥ 3 therapies used (3)
C1705108 (UMLS CUI-1)
C1515119 (UMLS CUI-2)
C0205449 (UMLS CUI-3)
C1524031 (UMLS CUI-4)
(Comment:en)
Item
Indicate the receipt of anti-resorptive medications or denosumab
integer
C0012544 (UMLS CUI [1])
C3839270 (UMLS CUI [2])
Question 2 of additional libido and use of sexual aids questions
Code List
Indicate the receipt of anti-resorptive medications or denosumab
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
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