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Case Report Form (HIPEC) Visit 13

1 forms  
Visit 13: Fifth cycle of post-OP Chemotherapy
Description

Visit 13: Fifth cycle of post-OP Chemotherapy

Patient ID
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C1269815
CRF number
Description

CRF number

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0449788
Date of visit
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Status of Patient and recording of CTCAE
Description

Status of Patient and recording of CTCAE

Has patient appeared for the planned visit?
Description

Patient Visit

Data type

boolean

Alias
UMLS CUI [1]
C1512346
If patient didn´t come for the scheduled visit, please call the patient and try to verify the reason why.
Description

Patient visit

Data type

text

Alias
UMLS CUI [1]
C1512346
Is the Patient deceased?
Description

Patient deceased

Data type

boolean

Alias
UMLS CUI [1]
C1555024
Please specify the date the patient died
Description

Date of death

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011065
Has a progressive disease been diagnosed?
Description

Progressive disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
Please give the date, the progression was diagnosed
Description

Progressive Disease date

Data type

date

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0011008
Recurrent Disease
Description

Relapse

Data type

boolean

Alias
UMLS CUI [1]
C0277556
Please give the date, the relapse was diagnosed
Description

Date of relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
Description

CTCAE

Data type

boolean

Alias
UMLS CUI [1]
C1516728
Postoperative intravenous chemotherapy
Description

Postoperative intravenous chemotherapy

Postoperative chemotherapy will be continued
Description

Postoperative chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0392920
Please specify the reason why, if chemotherapy will be discontinued
Description

Postoperative chemotherapy

Data type

text

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0392920
If chemotherapy will be continued, please specify the nature of the regimen used
Description

Postoperative chemotherapy

Data type

text

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0392920
Please specify the agent used for chemotherapy
Description

Postoperative chemotherapy

Data type

text

Alias
UMLS CUI [1,1]
C0032790
UMLS CUI [1,2]
C0392920
Please specify other chemotherapeutic agent used
Description

Other antineoplastic agent

Data type

text

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
Dose of Carboplatin administered
Description

Carboplatin

Data type

float

Measurement units
  • AUC
Alias
UMLS CUI [1]
C0079083
AUC
Dose of Paclitaxel administered
Description

Paclitaxel

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1]
C0144576
mg/m2
Dose of Gemcitabine administered
Description

Gemcitabine

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1]
C0045093
mg/m2
Dose of Doxorubicin liposome administered
Description

Doxorubicin liposome

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1]
C0717726
mg/m2
Dose of other antineoplastic agent administered
Description

Other antineoplastic agent

Data type

float

Measurement units
  • mg/m2
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
mg/m2
Course of chemotherapy cycle
Description

Course of chemotherapy cycle

Date of third chemotherapy cycle
Description

Date of third chemotherapy

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0392920
Total dose of Carboplatin administered
Description

Total dose of antineoplastic agent

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0178602
mg
Has the dose been modified?
Description

Dose modification

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Please specify what kind of dose modification was used
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Please specify the reason for the dose modification
Description

The reason for dose modification is an AE that has to be documented appropriately on the AE form.

Data type

text

Alias
UMLS CUI [1]
C1707811
Total dose of Paclitaxel administered
Description

Total dose of antineoplastic agent

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0178602
mg
Has the dose been modified?
Description

Dose modification

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Please specify what kind of dose modification was used
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Please specify the reason for the dose modification
Description

The reason for dose modification is an AE that has to be documented appropriately on the AE form.

Data type

text

Alias
UMLS CUI [1]
C1707811
Total dose of Gemcitabine administered
Description

Gemcitabine has to be administered on day 1 or day 8 of chemotherapy cycle.

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0178602
mg
Has the dose been modified?
Description

Dose modification

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Please specify what kind of dose modification was used
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Please specify the reason for the dose modification
Description

The reason for dose modification is an AE that has to be documented appropriately on the AE form.

Data type

text

Alias
UMLS CUI [1]
C1707811
Total dose of doxorubicin liposome administered
Description

Total dose of antineoplastic agent

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0178602
mg
Has the dose been modified?
Description

Dose modification

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Please specify what kind of dose modification has been used
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Please specify the reason for the dose modification
Description

The reason for dose modification is an AE that has to be documented appropriately on the AE form.

Data type

text

Alias
UMLS CUI [1]
C1707811
Total dose of other chemotherapeutic agent administered
Description

Total dose of antineoplastic agent

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0178602
mg
Has the dose been modified?
Description

Dose modification

Data type

boolean

Alias
UMLS CUI [1]
C1707811
Please specify what kind of dose modification has been used
Description

Dose modification

Data type

text

Alias
UMLS CUI [1]
C1707811
Please specify the reason for the dose modification
Description

The reason for dose modification is an AE that has to be documented appropriately on the AE form.

Data type

text

Alias
UMLS CUI [1]
C1707811
Any further oncologic treatments?
Description

Further antineoplastic treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1517331
Please specify any further antineoplastic treatments that have been carried out.
Description

Further antineoplastic treatment

Data type

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1517331
Confirmation of correctness
Description

Confirmation of correctness

Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date of completion of this form
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Case Report Form (HIPEC) Visit 13

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit 13: Fifth cycle of post-OP Chemotherapy
Patient ID
Item
Patient ID
integer
C1269815 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item Group
Status of Patient and recording of CTCAE
Patient Visit
Item
Has patient appeared for the planned visit?
boolean
C1512346 (UMLS CUI [1])
Patient visit
Item
If patient didn´t come for the scheduled visit, please call the patient and try to verify the reason why.
text
C1512346 (UMLS CUI [1])
Patient deceased
Item
Is the Patient deceased?
boolean
C1555024 (UMLS CUI [1])
Date of death
Item
Please specify the date the patient died
date
C0011008 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Progressive disease
Item
Has a progressive disease been diagnosed?
boolean
C1335499 (UMLS CUI [1])
Progressive Disease date
Item
Please give the date, the progression was diagnosed
date
C1335499 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Relapse
Item
Recurrent Disease
boolean
C0277556 (UMLS CUI [1])
Date of relapse
Item
Please give the date, the relapse was diagnosed
boolean
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
CTCAE
Item
Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form
boolean
C1516728 (UMLS CUI [1])
Item Group
Postoperative intravenous chemotherapy
Postoperative chemotherapy
Item
Postoperative chemotherapy will be continued
boolean
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Postoperative chemotherapy
Item
Please specify the reason why, if chemotherapy will be discontinued
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Item
If chemotherapy will be continued, please specify the nature of the regimen used
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Postoperative chemotherapy
Code List
If chemotherapy will be continued, please specify the nature of the regimen used
CL Item
monotherapy (1)
CL Item
combination therapy (2)
Item
Please specify the agent used for chemotherapy
text
C0032790 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Postoperative chemotherapy
Code List
Please specify the agent used for chemotherapy
CL Item
Carboplatin (1)
CL Item
Paclitaxel (2)
CL Item
Gemcitabine (used on first or eighth day of cycle) (3)
CL Item
Doxorubicin liposome (4)
CL Item
other (5)
Other antineoplastic agent
Item
Please specify other chemotherapeutic agent used
text
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Carboplatin
Item
Dose of Carboplatin administered
float
C0079083 (UMLS CUI [1])
Paclitaxel
Item
Dose of Paclitaxel administered
float
C0144576 (UMLS CUI [1])
Gemcitabine
Item
Dose of Gemcitabine administered
float
C0045093 (UMLS CUI [1])
Doxorubicin liposome
Item
Dose of Doxorubicin liposome administered
float
C0717726 (UMLS CUI [1])
Other antineoplastic agent
Item
Dose of other antineoplastic agent administered
float
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Course of chemotherapy cycle
Date of third chemotherapy
Item
Date of third chemotherapy cycle
date
C0011008 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Total dose of antineoplastic agent
Item
Total dose of Carboplatin administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify what kind of dose modification was used
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify the reason for the dose modification
CL Item
hematologic toxicity  (1)
CL Item
hypersensitivity  (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of Paclitaxel administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify what kind of dose modification was used
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify the reason for the dose modification
CL Item
hematologic toxicity  (1)
CL Item
hypersensitivity  (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of Gemcitabine administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification was used
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify what kind of dose modification was used
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify the reason for the dose modification
CL Item
hematologic toxicity  (1)
CL Item
hypersensitivity  (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of doxorubicin liposome administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification has been used
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify what kind of dose modification has been used
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify the reason for the dose modification
CL Item
hematologic toxicity  (1)
CL Item
hypersensitivity  (2)
CL Item
other (3)
Total dose of antineoplastic agent
Item
Total dose of other chemotherapeutic agent administered
integer
C0003392 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Dose modification
Item
Has the dose been modified?
boolean
C1707811 (UMLS CUI [1])
Item
Please specify what kind of dose modification has been used
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify what kind of dose modification has been used
CL Item
Dose reduction (1)
CL Item
Delay/Deceleration (2)
CL Item
Discontinuation (3)
Item
Please specify the reason for the dose modification
text
C1707811 (UMLS CUI [1])
Dose modification
Code List
Please specify the reason for the dose modification
CL Item
hematologic toxicity  (1)
CL Item
hypersensitivity  (2)
CL Item
other (3)
Further antineoplastic treatment
Item
Any further oncologic treatments?
boolean
C0920425 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Further antineoplastic treatment
Item
Please specify any further antineoplastic treatments that have been carried out.
text
C0920425 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
Item Group
Confirmation of correctness
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
Signature
Item
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
text
C1519316 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
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