English

Clinical Form within 6 months after treatment initiation

1 forms  
Patient ID
Description

Patient ID

Alias
UMLS CUI-1
C1269815
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

Data type

integer

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

This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc.

Data type

text

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

Treatment Variables

Alias
UMLS CUI-1
C0087111
Indicate the primary treatment modalities used for this patient 1 = Watchful waiting
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

INCLUSION CRITERIA: All patients If answered '7 = Focal therapy' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Free text

Data type

text

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

INCLUSION CRITERIA: All patients, If answered 'Watchful waiting' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Active surveillance' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Radical prostatectomy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered '3 = Radical prostatectomy' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered '4 = External beam radiation therapy (primary treatment or adjuvant following surgery)' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered '4 = External beam radiation therapy (primary treatment or adjuvant following surgery)' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Numerical value

Data type

float

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

INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'External beam radiation therapy' (PRIMARYTX), and no end date is entered (PREBRTTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

text

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

INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Brachytherapy' (PRIMARYTX), and no end date is entered (PRBRACHYTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered '3 = Brachytherapy' on primary treatment modalities (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Androgen deprivation therapy' (PRIMARYTX), and no end date is entered (PRADTTXSTOPDATE) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered 'Focal therapy' (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

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

Data type

integer

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

INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Free text

Data type

text

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

INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY

Data type

date

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

INCLUSION CRITERIA: All patients, If answered '888 = Other' on primary treatment modalities used (PRIMARYTX) TIMING: Within 6 months after primary treatment initiation REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

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

Acute Complications of Treatment

Alias
UMLS CUI-1
C0679861
Indicate whether patient experienced a Clavien grade III-V complication
Description

INCLUSION CRITERIA: Patients who undergo surgical interventions TIMING: Occurring within 6 months after primary or salvage radical prostatectomy REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C4055231
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
Description

INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Single answer

Data type

integer

Alias
UMLS CUI [1]
C1516728
If yes, note domain and grade 0 = No grade 3 or 4 toxicity
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Fatigue - Grade 1: Fatigue relieved by rest - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL - Grade 3: Fatigue not relieved by rest, limiting self care ADL - Grade 4: N/A Dermatitis radiation - Grade 1: Faint erythema or dry desquamation - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated Diarrhea - Grade 1: Increase of less than 4 stools per day over baseline; mild increase in ostomy output compared to baseline - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline - Grade 3: Increase of 7 or more stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Abdominal pain - Grade 1: Mild pain - Grade 2: Moderate pain; limiting instrumental ADL - Grade 3: Severe pain; limiting self care ADL - Grade 4: N/A Rectal mucositis - Grade 1: Asymptomatic or mild symptoms; intervention not indicated - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: Life-threatening consequences; urgent operative intervention indicated Proctitis - Grade 1: Rectal discomfort, intervention not indicated - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated Hot flashes - Grade 1: Mild symptoms; intervention not indicated - Grade 2: Moderate symptoms; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: N/A Cystitis non-infective - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated Urinary retention - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

boolean

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0549184
If yes, note domain and grade 1/2 = Fatigue grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Fatigue - Grade 1: Fatigue relieved by rest - Grade 2: Fatigue not relieved by rest; limiting instrumental ADL - Grade 3: Fatigue not relieved by rest, limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0015672
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Dermatitis radiation - Grade 1: Faint erythema or dry desquamation - Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema - Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion - Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0034561
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Diarrhea - Grade 1: Increase of less than 4 stools per day over baseline; mild increase in ostomy output compared to baseline - Grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline - Grade 3: Increase of 7 or more stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0011991
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Abdominal pain - Grade 1: Mild pain - Grade 2: Moderate pain; limiting instrumental ADL - Grade 3: Severe pain; limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0000737
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Rectal mucositis - Grade 1: Asymptomatic or mild symptoms; intervention not indicated - Grade 2: Symptomatic; medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: Life-threatening consequences; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C1328588
If yes, note domain and grade 11/12 = Proctitis grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Proctitis - Grade 1: Rectal discomfort, intervention not indicated - Grade 2: Symptoms (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL - Grade 3: Severe symptoms; fecal urgency or stool incontinence; limiting self care ADL - Grade 4: Life-threatening consequences; urgent intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0033246
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Hot flashes - Grade 1: Mild symptoms; intervention not indicated - Grade 2: Moderate symptoms; limiting instrumental ADL - Grade 3: Severe symptoms; limiting self care ADL - Grade 4: N/A INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0600142
If yes, note domain and grade 15/16 = Cystitis grade 3/4
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Cystitis non-infective - Grade 1: Microscopic hematuria; minimal increase in frequency, urgency, dysuria, or nocturia; new onset of incontinence - Grade 2: Moderate hematuria; moderate increase in frequency, urgency, dysuria, nocturia or incontinence; urinary catheter placement or bladder irrigation indicated; limiting instrumental ADL - Grade 3: Gross hematuria; transfusion, IV medications or hospitalization indicated; elective endoscopic, radiologic or operative intervention indicated - Grade 4: Life-threatening consequences; urgent radiologic or operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0010692
If yes, note domain and grade 17/18 = Urinary retention
Description

The CTCAE defines Grade 3 and 4 complications for the following categories as follows: Urinary retention - Grade 1: Urinary, suprapubic or intermittent catheter placement not indicated; able to void with some residual - Grade 2: Placement of urinary, suprapubic or intermittent catheter placement indicated; medication indicated - Grade 3: Elective operative or radiologic intervention indicated; substantial loss of affected kidney function or mass - Grade 4: Life-threatening consequences; organ failure; urgent operative intervention indicated INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0080274
If yes, note domain and grade 19/20 = Other grade 3/4
Description

INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Multiple answer, Arrange as array (see sample questionnaire)

Data type

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0205394
Indicate the CTCAE domain of the grade 3 or 4 complication
Description

INCLUSION CRITERIA: All patients undergoing primary or salvage radiation therapy, If answered '19 = Other grade 3' or '20 = Other grade 4' on CTCAE domain and grade (COMPLRADDOMGRA) TIMING: During primary or salvage radiation therapy treatment and the 6 months following completion of therapy REPORTING SOURCE: Clinical TYPE: Free text

Data type

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2699044
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Similar models

Clinical Form within 6 months after treatment initiation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient ID
C1269815 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Treatment Variables
C0087111 (UMLS CUI-1)
Treatment modalities used: Watchful waiting
Item
Indicate the primary treatment modalities used for this patient 1 = Watchful waiting
boolean
C1298659 (UMLS CUI [1])
Treatment modalities used: Active surveillance
Item
Indicate the primary treatment modalities used for this patient 2 = Active surveillance
boolean
C0920425 (UMLS CUI [1,1])
C1827061 (UMLS CUI [1,2])
Treatment modalities used: Radical prostatectomy
Item
Indicate the primary treatment modalities used for this patient 3 = Radical prostatectomy
boolean
C0920425 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
Treatment modalities used: External beam radiation therapy
Item
Indicate the primary treatment modalities used for this patient 4 = External beam radiation therapy (primary treatment or adjuvant following surgery)
boolean
C0920425 (UMLS CUI [1,1])
C1517033 (UMLS CUI [1,2])
Treatment modalities used: Brachytherapy
Item
Indicate the primary treatment modalities used for this patient 5 = Brachytherapy
boolean
C0920425 (UMLS CUI [1,1])
C0006098 (UMLS CUI [1,2])
Treatment modalities used: Androgen deprivation therapy
Item
Indicate the primary treatment modalities used for this patient 6 = Androgen deprivation therapy
boolean
C0920425 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
Treatment modalities used: Focal therapy
Item
Indicate the primary treatment modalities used for this patient 7 = Focal therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Treatment modalities used: Other
Item
Indicate the primary treatment modalities used for this patient 888 = Other
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Type of focal therapy
Item
Indicate the type of focal therapy used for this patient
text
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Date watchful waiting initiated
Item
Indicate date watchful waiting initiated
date
C1298659 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date active surveillance initiated
Item
Inidicate date active surveillance initiated
date
C1827061 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Date of primary radical prostatectomy
Item
Indicate date of primary radical prostatectomy
date
C0194810 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate if the primary surgical approach was nerve-sparing or non-nerve-sparing
integer
C1514120 (UMLS CUI [1,1])
C1512698 (UMLS CUI [1,2])
Primary nerve sparing status
Code List
Indicate if the primary surgical approach was nerve-sparing or non-nerve-sparing
CL Item
Non-nerve-sparing (1)
C0033573 (UMLS CUI-1)
C0445089 (UMLS CUI-2)
(Comment:en)
CL Item
Nerve-sparing (2)
C1514120 (UMLS CUI-1)
(Comment:en)
Primary external Beam Radiation Therapy: Dose (Gray)
Item
Indicate the total dose of primary External Beam Radiation Therapy
integer
C1517033 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Primary external Beam Radiation Therapy: Average dose per fraction (Gray)
Item
Indicate the average dose per fraction of primary External Beam Radiation Therapy
float
C0860348 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264633 (UMLS CUI [1,3])
Start date of primary external beam radiation therapy
Item
Indicate start date of primary external beam radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary external beam radiation therapy
Item
Indicate stop date of primary external radiation therapy
date
C1517033 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary external beam radiation therapy is ongoing
text
C1517033 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Ongoing primary external beam radiation therapy
Code List
Indicate if primary external beam radiation therapy is ongoing
CL Item
Treatment ongoing (1)
C1517033 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of primary brachytherapy
Item
Indicate start date of primary brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary brachytherapy
Item
Indicate stop date of primary brachytherapy
date
C0006098 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary brachytherapy is ongoing
integer
C0006098 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Ongoing primary brachytherapy
Code List
Indicate if primary brachytherapy is ongoing
CL Item
Treatment ongoing (1)
C0006098 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Item
Indicate whether high-dose or low-dose brachytherapy was given
integer
C0006098 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Primary brachytherapy dose
Code List
Indicate whether high-dose or low-dose brachytherapy was given
CL Item
Low dose (1)
C0454271 (UMLS CUI-1)
(Comment:en)
CL Item
High dose (2)
C0454270 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Start date of primary androgen deprivation therapy
Item
Indicate start date of primary androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop date of primary androgen deprivation therapy
Item
Indicate stop date of primary androgen deprivation therapy
date
C0279492 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Indicate if primary androgen deprivation therapy is ongoing
integer
C0279492 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Ongoing primary androgen deprivation therapy
Code List
Indicate if primary androgen deprivation therapy is ongoing
CL Item
Treatment ongoing (1)
C0279492 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
(Comment:en)
Start date of primary focal therapy
Item
Indicate start date of primary focal therapy
date
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of primary focal therapy
Item
Indicate stop date of primary focal therapy
date
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if primary focal therapy is ongoing
integer
C0920425 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Ongoing primary focal therapy
Code List
Indicate if primary focal therapy is ongoing
CL Item
Treatment ongoing (1)
C0920425 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
Primary treatment modality other than those explicitly listed
Item
Indicate the other primary treatment modality used
text
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Start date of other primary therapy
Item
Indicate start date of other primary therapy
date
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Stop date of other primary therapy
Item
Indicate stop date of other primary therapy
date
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
Indicate if other primary therapy is ongoing
integer
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Ongoing other therapy
Code List
Indicate if other primary therapy is ongoing
CL Item
Treatment ongoing (1)
C0920425 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0549178 (UMLS CUI-3)
(Comment:en)
Item Group
Acute Complications of Treatment
C0679861 (UMLS CUI-1)
Item
Indicate whether patient experienced a Clavien grade III-V complication
integer
C0009566 (UMLS CUI [1,1])
C4055231 (UMLS CUI [1,2])
Clavien complication (maximum grade)
Code List
Indicate whether patient experienced a Clavien grade III-V complication
CL Item
No (0)
C4032686 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, grade 3 (1)
C4050000 (UMLS CUI-1)
(Comment:en)
CL Item
Yes, grade 4 (2)
C4050001 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
integer
C1516728 (UMLS CUI [1])
CTCAE grade 3 or 4 complication during treatment or within 6 months after completing treatment
Code List
Indicate whether the patient experienced a CTCAE grade 3 or 4 complication during treatment with radiation therapy or within the first 6 months following the completion of radiation therapy
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
CTCAE domain and grade: None
Item
If yes, note domain and grade 0 = No grade 3 or 4 toxicity
boolean
C1516728 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item
If yes, note domain and grade 1/2 = Fatigue grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
CTCAE domain and grade: Fatigue
Code List
If yes, note domain and grade 1/2 = Fatigue grade 3/4
CL Item
No fatigue grade 3 or 4 toxicity (0)
C1556365 (UMLS CUI-1)
C1556364 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Fatigue grade 3 (1)
C1556364 (UMLS CUI-1)
(Comment:en)
CL Item
Fatigue grade 4 (2)
C1556365 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0034561 (UMLS CUI [1,2])
CTCAE domain and grade: Dermatitis
Code List
If yes, note domain and grade 3/4 = Dermatitis grade 3/4
CL Item
No Dermatitis grade 3 or 4 toxicity (0)
C1298908 (UMLS CUI-1)
C1519275 (UMLS CUI-2)
C1517874 (UMLS CUI-3)
C0011603 (UMLS CUI-4)
(Comment:en)
CL Item
Dermatitis grade 3 (3)
C1519275 (UMLS CUI-1)
C0011603 (UMLS CUI-2)
(Comment:en)
CL Item
Dermatitis grade 4 (4)
C1517874 (UMLS CUI-1)
C0011603 (UMLS CUI-2)
(Comment:en)
Item
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])
CTCAE domain and grade: Diarrhea
Code List
If yes, note domain and grade 5/6 = Diarrhea grade 3/4
CL Item
No Diarrhea grade 3 or 4 toxicity (0)
C1559310 (UMLS CUI-1)
C1559311 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Diarrhea grade 3 (5)
C1559310 (UMLS CUI-1)
(Comment:en)
CL Item
Diarrhea grade 4 (6)
C1559311 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0000737 (UMLS CUI [1,2])
CTCAE domain and grade: Abdominal Pain
Code List
If yes, note domain and grade 7/8 = Abdominal pain grade 3/4
CL Item
No Abdominal pain grade 3 or 4 toxicity (0)
C1557401 (UMLS CUI-1)
C1557400 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Abdominal pain grade 3 (7)
C1557400 (UMLS CUI-1)
(Comment:en)
CL Item
Abdominal pain grade 4 (8)
C1557401 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C1328588 (UMLS CUI [1,2])
CTCAE domain and grade: Rectal mucositis
Code List
If yes, note domain and grade 9/10 = Rectal mucositis grade 3/4
CL Item
No Rectal mucositis grade 3 or 4 toxicity (0)
C1556390C1556391 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
(Comment:en)
CL Item
Rectal mucositis grade 3 (9)
C1556390 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal mucositis grade 4 (10)
C1556391 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 11/12 = Proctitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0033246 (UMLS CUI [1,2])
CTCAE domain and grade: Proctitis
Code List
If yes, note domain and grade 11/12 = Proctitis grade 3/4
CL Item
No Proctitis grade 3 or 4 toxicity (0)
C1559353 (UMLS CUI-1)
C1559354 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Proctitis grade 3 (11)
C1559353 (UMLS CUI-1)
(Comment:en)
CL Item
Proctitis grade 4 (12)
C1559354 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0600142 (UMLS CUI [1,2])
CTCAE domain and grade: Hot flashes
Code List
If yes, note domain and grade 13/14 = Hot flashes grade 3/4
CL Item
No grade 3 or 4 toxicity (0)
C1559217 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
C0600142 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
CL Item
Hot flashes grade 3 (13)
C1559217 (UMLS CUI-1)
(Comment:en)
CL Item
Hot flashes grade 4 (14)
C1517874 (UMLS CUI-1)
C0600142 (UMLS CUI-2)
(Comment:en)
Item
If yes, note domain and grade 15/16 = Cystitis grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0010692 (UMLS CUI [1,2])
CTCAE domain and grade: Cystitis
Code List
If yes, note domain and grade 15/16 = Cystitis grade 3/4
CL Item
No Cystitis grade 3 or 4 toxicity (0)
C1557813 (UMLS CUI-1)
C1557814 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Cystitis non-infective grade 3 (15)
C1557813 (UMLS CUI-1)
(Comment:en)
CL Item
Cystitis non-infective grade 4 (16)
C1557814 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 17/18 = Urinary retention
integer
C1516728 (UMLS CUI [1,1])
C0080274 (UMLS CUI [1,2])
CTCAE domain and grade: Urinary retention
Code List
If yes, note domain and grade 17/18 = Urinary retention
CL Item
No Urinary retention grade 3 or 4 toxicity (0)
C1558145 (UMLS CUI-1)
C1558144 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
(Comment:en)
CL Item
Urinary retention grade 3 (17)
C1558144 (UMLS CUI-1)
(Comment:en)
CL Item
Urinary retention grade 4 (18)
C1558145 (UMLS CUI-1)
(Comment:en)
Item
If yes, note domain and grade 19/20 = Other grade 3/4
integer
C1516728 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
CTCAE domain and grade: Other
Code List
If yes, note domain and grade 19/20 = Other grade 3/4
CL Item
No other grade 3 or 4 toxicity (0)
C1519275 (UMLS CUI-1)
C1517874 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C1298908 (UMLS CUI-4)
(Comment:en)
CL Item
Other grade 3 (19)
C1519275 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
CL Item
Other grade 4 (20)
C1517874 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
(Comment:en)
CTCAE domain other than those explicitly listed
Item
Indicate the CTCAE domain of the grade 3 or 4 complication
text
C1516728 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2699044 (UMLS CUI [1,3])
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