ID

30413

Beschrijving

Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Trefwoorden

Versies (2)
  1. 03-06-18 03-06-18 -
  2. 03-06-18 03-06-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 juni 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Oral GW786034 treatment for ovarian cancer NCT00281632

Engels

Additional Forms

1 Formulieren  
  1. StudyEvent: ODM
    1. Additional Forms
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
investigational product discontinuation
Beschrijving

investigational product discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Give primary reason Investigational Product was discontinued permanently
Beschrijving

reason drug discontinuation

Datatype

text

Alias
UMLS CUI [1,1]
C4288399
UMLS CUI [1,2]
C0392360
Other, please specify
Beschrijving

other reason for drug discontinuation

Datatype

text

Alias
UMLS CUI [1,1]
C4288399
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C3840932
PGx-Pharmacogenetic Research
Beschrijving

PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C0031325
Has informed consent been obtained for PGx-Pharmacogenetic research?
Beschrijving

consent for pgx-pharmacogenetic research

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Beschrijving

Informed consent if yes

Datatype

date

Alias
UMLS CUI [1,1]
C2985782
UMLS CUI [1,2]
C2347500
If no, pick one reason.
Beschrijving

if no in the item "consent for PGx-pharmacogenetic research", pick one reason. If Z = other, specify in the "other reason, specify" item.

Datatype

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Has a blood sample been collected for PGx-pharmacogenetic research?
Beschrijving

blood sample collection dna pharmacogenetic research

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
Record date sample taken
Beschrijving

date sample taken pharmacogenetic research

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C2347500
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

Withdrawal of consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347501
Has a request been made for sample destruction?
Beschrijving

Blood sample destruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
Reason for sample destruction
Beschrijving

Please specify if "Has a request been made for sample destruction?"=Yes

Datatype

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0370003
UMLS CUI [1,3]
C0392360
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Where any concomitant medications taken by the subject prior to screening and/or during the study?
Beschrijving

Concomitant Medications

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
If Yes to Concominant Medication
Beschrijving

If Yes to Concominant Medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name Preferred)
Beschrijving

Drug name

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Unit Dose
Beschrijving

Unit Dose

Datatype

float

Alias
UMLS CUI [1]
C2826646
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C2347852
Frequency
Beschrijving

Frequency concomitant medication

Datatype

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C2347852
Medical Condition
Beschrijving

Where appropriate, medical conditions should be recorded in the Significant Medical/Surgical History and Physical Examination section, utilizing the same terminology. Prior chemotherapy, biological, and immunotherapy should be recorded on pages 4 and 5. Record PM for prophylactic treatment with the Medical Condition for prophylactically administered medications.

Datatype

text

Alias
UMLS CUI [1]
C3843040
Start Date (be as precise as possible)
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
Taken Prior to Study?
Beschrijving

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
End Date
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2826257
UMLS CUI [1,3]
C2347852
Ongoing medication?
Beschrijving

Ongoing medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
NON-SERIOUS ADVERSE EVENTS (AE)
Beschrijving

NON-SERIOUS ADVERSE EVENTS (AE)

Did the subject experience any non-serious adverse events during the study?
Beschrijving

If Yes, record details below.

Datatype

text

Adverse events
Beschrijving

Record details of any new non-serious adverse events / serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events / Serious Adverse Events section.

Datatype

text

Alias
UMLS CUI [1]
C0877248
NON-SERIOUS ADVERSE EVENTS (AE)
Beschrijving

NON-SERIOUS ADVERSE EVENTS (AE)

Event
Beschrijving

Enter only the diagnosis (if known); otherwise enter sign or symptom. If a diagnosis subsequently becomes available, then this should be entered and the sign or symptom crossed out, initialled and dated by the investigator.

Datatype

text

Start Date
Beschrijving

Record the start date of the first occurrence of the AE.

Datatype

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschrijving

All AEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the AE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the AE was ongoing at the time of death, but was not the cause of death.

Datatype

integer

End Date
Beschrijving

Record the end date. This is the date the AE Recovered/Resolved. If the event Recovered/Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the AE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Datatype

date

Alias
UMLS CUI [1]
C0806020
Maximum Toxicity
Beschrijving

Maximum Toxicity

Datatype

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschrijving

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing).

Datatype

text

Did the subject withdraw from study as a result of this AE?
Beschrijving

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Datatype

text

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datatype

text

Serious adverse event
Beschrijving

Serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any serious adverse event between the previous contact and this contact?
Beschrijving

If 'yes, please complete the Serious Adverse Event form.

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Section 1
Beschrijving

Section 1

If fatal, was a post-mortem/autopsy performed?
Beschrijving

autopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0004398
UMLS CUI [2]
C1519255
Event
Beschrijving

Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. If a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE however if multiple SAEs which are temporally or clinically related are apparent at the time of initial reporting then these may be reported on the same page.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Start date
Beschrijving

Record the start date of the first occurrence of the SAE.

Datatype

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschrijving

All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was ’Recovered/Resolved’ or ’Recovered/Resolved with sequelae’. If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as ’Not recovered/Not resolved’ or ’Recovering/Resolving’. Also enter ’Not recovered/Not resolved’ if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beschrijving

Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/ Resolved with sequelae, enter the date the subject’s medical condition resolved or stabilised. Leave blank if the SAE is ’Not recovered/Not resolved’ or ’Recovering/Resolving’.

Datatype

date

Alias
UMLS CUI [1]
C0806020
Maximum Toxicity
Beschrijving

Maximum Toxicity

Datatype

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the SAE
Beschrijving

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced =Dose is reduced for one or more investigational product(s). Dose increased =Dose increased for one or more investigational product(s). Dose not changed=Investigational product(s) continues even though an adverse event has occurred. Dose interrupted=Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable=Subject was not receiving investigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).

Datatype

text

Alias
UMLS CUI [1]
C2826626
Did the subject withdraw from study as a result of this SAE?
Beschrijving

Indicate ’Yes’ if the event(s) were directly responsible for the subject’s withdrawal as indicated on the Study Conclusion page, otherwise indicate ’No’.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschrijving

It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
Section 2: Seriousness
Beschrijving

Section 2: Seriousness

[A] Results in death
Beschrijving

SAE results in death

Datatype

boolean

Alias
UMLS CUI [1]
C0011065
[B] Is life-threatening
Beschrijving

SAE is life-threatening

Datatype

boolean

Alias
UMLS CUI [1]
C2826244
[C] Requires hospitalisation or prolongation of existing hospitalisation
Beschrijving

SAE requires hospitalisation

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
[D] Results in disability/incapacity
Beschrijving

SAE results in disability/incapacity

Datatype

boolean

Alias
UMLS CUI [1]
C0231170
[E] Congenital anomaly/birth defect
Beschrijving

Congenital anomaly/birth defect

Datatype

boolean

Alias
UMLS CUI [1]
C0000768
[F] Other
Beschrijving

Óther SAE

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1880177
Other, specify
Beschrijving

Other SAE specificationn

Datatype

text

Alias
UMLS CUI [1]
C3845569
SECTION 3 Demography Data
Beschrijving

SECTION 3 Demography Data

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0011298
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4
Beschrijving

SECTION 4

If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered
Beschrijving

Recurring Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Section 5
Beschrijving

Section 5

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Possible Causes of SAE Other Than Investigational Product(s)
Beschrijving

Possible Causes of SAE Other Than Investigational Product(s)

Datatype

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
If "Medical condition(s)", specify:
Beschrijving

If

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0012634
If "Concomitant medication(s)", specify:
Beschrijving

If "Concomitant medication(s)", specify:

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C2347852
If "Other", specify:
Beschrijving

If "Other", specify:

Datatype

text

Alias
UMLS CUI [1]
C2348235
SECTION 6: RELEVANT Medical Conditions
Beschrijving

SECTION 6: RELEVANT Medical Conditions

Alias
UMLS CUI-1
C0262926
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
Beschrijving

Relevant Medical Conditions

Datatype

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1519255
Date of onset
Beschrijving

Date of onset

Datatype

date

Alias
UMLS CUI [1]
C0574845
Condition Present at Time of the SAE?
Beschrijving

continuation SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C1519255
If No, Date of Last Occurrence
Beschrijving

Date of Last Occurrence

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2745955
SECTION 7 Other RELEVANT Risk Factors
Beschrijving

SECTION 7 Other RELEVANT Risk Factors

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C0035648
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
Beschrijving

Risk Factors substance use disorder occupational hazard

Datatype

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0038586
UMLS CUI [1,3]
C0337074
SECTION 8 RELEVANT Concomitant Medications
Beschrijving

SECTION 8 RELEVANT Concomitant Medications

Alias
UMLS CUI-1
C1828479
UMLS CUI-2
C2347852
Drug Name
Beschrijving

Drug Name

Datatype

text

Alias
UMLS CUI [1]
C0013227
Dose
Beschrijving

Dose

Datatype

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beschrijving

Unit

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Beschrijving

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beschrijving

Stop Date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beschrijving

Ongoing Medication?

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
SECTION 9: Drug Details
Beschrijving

SECTION 9: Drug Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C1522508
Date reduced
Beschrijving

Only if applicable

Datatype

date

Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C0011008
Dose
Beschrijving

if applicable

Datatype

float

Maateenheden
  • mg/Day
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1707814
mg/Day
Please specify reason for dose reduction
Beschrijving

Dosage reduction

Datatype

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0547047
Start Date Investigational Product
Beschrijving

Start Date Investigational Product

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013230
Stop Date Investigational Product
Beschrijving

Stop Date Investigational Product

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013230
Dose
Beschrijving

Dose

Datatype

float

Maateenheden
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
SECTION 10: Details of RELEVANT Assessments
Beschrijving

SECTION 10: Details of RELEVANT Assessments

Alias
UMLS CUI-1
C0220825
Details of Relevant Assessments
Beschrijving

Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE e.g., laboratory data with units and normal range.

Datatype

text

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1519255
SECTION 11 Narrative Remarks
Beschrijving

SECTION 11 Narrative Remarks

Alias
UMLS CUI-1
C1828479
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
Beschrijving

comment SAE

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
Investigator’s signature
Beschrijving

Investigator signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name
Beschrijving

Investigator name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Pregnancy information
Beschrijving

Pregnancy information

Alias
UMLS CUI-1
C0032961
Has the patient become pregnant to date?
Beschrijving

If ’Yes’ please record details on the Pregnancy Notification Form, if not already completed and withdraw the patient.

Datatype

text

Alias
UMLS CUI [1]
C0032961
Death
Beschrijving

Death

Alias
UMLS CUI-1
C0011065
Date of Death
Beschrijving

Date of Death

Datatype

date

Maateenheden
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1148348
dd-mmm-yyyy
Reason for death:
Beschrijving

Cause of Death

Datatype

text

Alias
UMLS CUI [1]
C0007465
Other, Specify:
Beschrijving

Cause of Death Specification

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0007465
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
Date of subject completion or withdrawal
Beschrijving

Date of subject completion or withdrawal

Datatype

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from study?
Beschrijving

withdrawn

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
If Yes, tick the primary reason for withdrawal
Beschrijving

If Yes, tick the primary reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0422727
Investigator comment log
Beschrijving

Investigator comment log

CRF page number if applicable
Beschrijving

CRF page number

Datatype

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1516308
UMLS CUI [1,3]
C1515022
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Investigators Signature
Beschrijving

Investigators Signature

Alias
UMLS CUI-1
C1519316
Date of Signature
Beschrijving

Date of Signature

Datatype

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
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Additional Forms

1 Formulieren
  1. StudyEvent: ODM
    1. Additional Forms
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
investigational product discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Give primary reason Investigational Product was discontinued permanently
text
C4288399 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason drug discontinuation
Code List
Give primary reason Investigational Product was discontinued permanently
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Event pages as appropriate) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Other. specify (Z)
CL Item
Disease progression (7)
CL Item
Completed specified protocol dosing schedule (26)
CL Item
Death (record details on the Death page and/or the SAE page as appropriate) (25)
CL Item
Investigator decision (31)
other reason for drug discontinuation
Item
Other, please specify
text
C4288399 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Item Group
PGx-Pharmacogenetic Research
C0031325 (UMLS CUI-1)
consent for pgx-pharmacogenetic research
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2985782 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Item
If no, pick one reason.
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for no consent for pharmacogenetic research
Code List
If no, pick one reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
other reason (Z)
blood sample collection dna pharmacogenetic research
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
date sample taken pharmacogenetic research
Item
Record date sample taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Withdrawal of consent
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1,1])
C2347501 (UMLS CUI [1,2])
Blood sample destruction
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
Reason for sample destruction
text
C1948029 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for sample destruction
Code List
Reason for sample destruction
CL Item
Subject requested (1)
CL Item
Other, specify (Z)
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Where any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Item Group
If Yes to Concominant Medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade name Preferred)
text
C2360065 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intramuscular (IM)
CL Item
Inhalation (IH)
CL Item
Intravenous (IV)
CL Item
Nasal (NS)
CL Item
Topical (TP)
CL Item
Oral (PO)
CL Item
Vaginal (VG)
Unit Dose
Item
Unit Dose
float
C2826646 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Units
Code List
Units
CL Item
Tablet (TAB)
CL Item
Microlitre (MCL)
CL Item
Millilitre (ML)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Milligram (MG)
CL Item
Gram (G)
Item
Frequency
text
C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Frequency concomitant medication
Code List
Frequency
CL Item
1x daily (OD/QD)
CL Item
2x daily (BID)
CL Item
3x daily (TID)
CL Item
4x daily (QID)
CL Item
As required (PRN)
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2826257 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Ongoing medication
Item
Ongoing medication?
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
NON-SERIOUS ADVERSE EVENTS (AE)
Item
Did the subject experience any non-serious adverse events during the study?
text
non-serious adverse events
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Adverse events
Item
Adverse events
text
C0877248 (UMLS CUI [1])
Item Group
NON-SERIOUS ADVERSE EVENTS (AE)
Event
Item
Event
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Item
Maximum Toxicity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Toxicity
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Not applicable (X)
CL Item
Grade 4 (4)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
Action Taken with IP
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
Withdrawal
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
Cause of Adverse event
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
serious adverse event
Item
Did the subject experience any serious adverse event between the previous contact and this contact?
boolean
C1519255 (UMLS CUI [1])
autopsy
Item
If fatal, was a post-mortem/autopsy performed?
boolean
C0004398 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Event
Item
Event
boolean
C0877248 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal (5)
C1705586 (UMLS CUI-1)
C0004398 (UMLS CUI-2)
(Comment:en)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Item
Maximum Toxicity
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Toxicity
CL Item
Grade 1 (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 2 (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 3 (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
text
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) withdrawn (1)
C0013230 (UMLS CUI-1)
(Comment:en)
CL Item
Dose reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Dose increased (3)
C1707810 (UMLS CUI-1)
(Comment:en)
CL Item
Dose not changed (4)
C0178602 (UMLS CUI-1)
C0442739 (UMLS CUI-2)
(Comment:en)
CL Item
Dose interrupted (5)
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
(Comment:en)
CL Item
Not applicable (X)
C1272460 (UMLS CUI-1)
(Comment:en)
withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Section 2: Seriousness
SAE results in death
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
SAE is life-threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
SAE requires hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
SAE results in disability/incapacity
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
Congenital anomaly/birth defect
Item
[E] Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1])
Óther SAE
Item
[F] Other
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
Other SAE specificationn
Item
Other, specify
text
C3845569 (UMLS CUI [1])
Item Group
SECTION 3 Demography Data
C1828479 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
SECTION 4
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered
integer
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
If lnvestigational Product(s) was Stopped
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Section 5
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Causes of SAE Other Than Investigational Product(s)
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Causes of SAE Other Than Investigational Product(s)
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication(s) (5)
CL Item
Activity related to study participation (e.g., procedures) (6)
CL Item
Other (7)
If
Item
If "Medical condition(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
If "Concomitant medication(s)", specify:
Item
If "Concomitant medication(s)", specify:
text
C2348235 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
If "Other", specify:
Item
If "Other", specify:
text
C2348235 (UMLS CUI [1])
Item Group
SECTION 6: RELEVANT Medical Conditions
C0262926 (UMLS CUI-1)
Relevant Medical Conditions
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE.
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Item
Condition Present at Time of the SAE?
text
C0805733 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Condition Present at Time of the SAE
Code List
Condition Present at Time of the SAE?
CL Item
Yes (Y)
CL Item
No (N)
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C0011008 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Item Group
SECTION 7 Other RELEVANT Risk Factors
C1828479 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
Risk Factors substance use disorder occupational hazard
Item
Other RELEVANT Risk Factors (provide any family or social history (e.g., smoking, alcohol, diet, drug abuse, occupational hazard) relevant to the SAE)
text
C0035648 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
C0337074 (UMLS CUI [1,3])
Item Group
SECTION 8 RELEVANT Concomitant Medications
C1828479 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
integer
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Ongoing Medication?
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
SECTION 9: Drug Details
C0013227 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Date dose reduced
Item
Date reduced
date
C1707814 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dose reduced
Item
Dose
float
C0178602 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Dosage reduction
Item
Please specify reason for dose reduction
text
C0178602 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0808070 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Stop Date Investigational Product
Item
Stop Date Investigational Product
date
C0806020 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
SECTION 10: Details of RELEVANT Assessments
C0220825 (UMLS CUI-1)
Details of Relevant Assessments
Item
Details of Relevant Assessments
text
C1261322 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
SECTION 11 Narrative Remarks
C1828479 (UMLS CUI-1)
comment SAE
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Has the patient become pregnant to date?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Death
C0011065 (UMLS CUI-1)
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Reason for death:
text
C0007465 (UMLS CUI [1])
Reason for Death
Code List
Reason for death:
CL Item
Disease under sutdy (1)
CL Item
Toxicity (2)
CL Item
Other, specify (OT)
Cause of Death Specification
Item
Other, Specify:
text
C2348235 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
withdrawn
Item
Was the subject withdrawn from study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If Yes, tick the primary reason for withdrawal
text
C0392360 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Pregnancy information
Code List
If Yes, tick the primary reason for withdrawal
CL Item
Adverse event (Record details on the Non-Serious Adverse Events or Serious Adverse (1)
(Comment:en)
CL Item
Lost to follow-up (2)
(Comment:en)
CL Item
Protocol violation (3)
(Comment:en)
CL Item
Subject decided to withdraw from the study (4)
(Comment:en)
CL Item
Sponsor terminated study (6)
(Comment:en)
CL Item
Disease progression (7)
(Comment:en)
CL Item
Death (25)
(Comment:en)
CL Item
Investigator descision (26)
(Comment:en)
CL Item
Other (Z)
(Comment:en)
Item Group
Investigator comment log
CRF page number
Item
CRF page number if applicable
integer
C0237753 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
C1515022 (UMLS CUI [1,3])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigators Signature
C1519316 (UMLS CUI-1)
Date of Signature
Item
Date of Signature
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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