ID

30415

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-06-03 2018-06-03 -
  2. 2018-06-03 2018-06-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 juni 2018

DOI

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Licens

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

Engelsk

Additional Forms

1 Formulär  
  1. StudyEvent: ODM
    1. Additional Forms
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
investigational product discontinuation
Beskrivning

investigational product discontinuation

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

reason drug discontinuation

Datatyp

text

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

other reason for drug discontinuation

Datatyp

text

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

PGx-Pharmacogenetic Research

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

consent for pgx-pharmacogenetic research

Datatyp

boolean

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

Informed consent if yes

Datatyp

date

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

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

Datatyp

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?
Beskrivning

blood sample collection dna pharmacogenetic research

Datatyp

boolean

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

date sample taken pharmacogenetic research

Datatyp

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?
Beskrivning

Withdrawal of consent

Datatyp

boolean

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

Blood sample destruction

Datatyp

boolean

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

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

Datatyp

text

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

Concomitant Medications

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

Concomitant Medications

Datatyp

boolean

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

If Yes to Concominant Medication

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

Drug name

Datatyp

text

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

Route

Datatyp

text

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

Unit Dose

Datatyp

float

Alias
UMLS CUI [1]
C2826646
Units
Beskrivning

Units

Datatyp

text

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

Frequency concomitant medication

Datatyp

text

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

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.

Datatyp

text

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

Start Date

Datatyp

date

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

Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
End Date
Beskrivning

End Date

Datatyp

date

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

Ongoing medication

Datatyp

boolean

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

NON-SERIOUS ADVERSE EVENTS (AE)

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

If Yes, record details below.

Datatyp

text

Adverse events
Beskrivning

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.

Datatyp

text

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

NON-SERIOUS ADVERSE EVENTS (AE)

Event
Beskrivning

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.

Datatyp

text

Start Date
Beskrivning

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

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beskrivning

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.

Datatyp

integer

End Date
Beskrivning

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’.

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Toxicity
Beskrivning

Maximum Toxicity

Datatyp

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
Beskrivning

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).

Datatyp

text

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

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

Datatyp

text

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

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.

Datatyp

text

Serious adverse event
Beskrivning

Serious adverse event

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Section 1
Beskrivning

Section 1

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

autopsy

Datatyp

boolean

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Start date
Beskrivning

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

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beskrivning

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.

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
End Date
Beskrivning

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’.

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Toxicity
Beskrivning

Maximum Toxicity

Datatyp

text

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

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).

Datatyp

text

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

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

Datatyp

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?
Beskrivning

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.

Datatyp

boolean

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

Section 2: Seriousness

[A] Results in death
Beskrivning

SAE results in death

Datatyp

boolean

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

SAE is life-threatening

Datatyp

boolean

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

SAE requires hospitalisation

Datatyp

boolean

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

SAE results in disability/incapacity

Datatyp

boolean

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

Congenital anomaly/birth defect

Datatyp

boolean

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

Óther SAE

Datatyp

boolean

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

Other SAE specificationn

Datatyp

text

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

SECTION 3 Demography Data

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

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
SECTION 4
Beskrivning

SECTION 4

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

Recurring Adverse Event

Datatyp

integer

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

Section 5

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

Possible Causes of SAE Other Than Investigational Product(s)

Datatyp

text

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

If

Datatyp

text

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

If "Concomitant medication(s)", specify:

Datatyp

text

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

If "Other", specify:

Datatyp

text

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

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.
Beskrivning

Relevant Medical Conditions

Datatyp

text

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

Date of onset

Datatyp

date

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

continuation SAE

Datatyp

text

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

Date of Last Occurrence

Datatyp

date

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

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)
Beskrivning

Risk Factors substance use disorder occupational hazard

Datatyp

text

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

SECTION 8 RELEVANT Concomitant Medications

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

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Dose
Beskrivning

Dose

Datatyp

integer

Alias
UMLS CUI [1]
C3174092
Unit
Beskrivning

Unit

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beskrivning

Route

Datatyp

text

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

Taken Prior to Study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

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

SECTION 9: Drug Details

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

Only if applicable

Datatyp

date

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

if applicable

Datatyp

float

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

Dosage reduction

Datatyp

text

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

Start Date Investigational Product

Datatyp

date

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

Stop Date Investigational Product

Datatyp

date

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

Dose

Datatyp

float

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

SECTION 10: Details of RELEVANT Assessments

Alias
UMLS CUI-1
C0220825
Details of Relevant Assessments
Beskrivning

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.

Datatyp

text

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

SECTION 11 Narrative Remarks

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

comment SAE

Datatyp

text

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

Investigator signature

Datatyp

text

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Pregnancy information
Beskrivning

Pregnancy information

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

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

Datatyp

text

Alias
UMLS CUI [1]
C0032961
Death
Beskrivning

Death

Alias
UMLS CUI-1
C0011065
Date of Death
Beskrivning

Date of Death

Datatyp

date

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

Cause of Death

Datatyp

text

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

Cause of Death Specification

Datatyp

text

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

Study Conclusion

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

Date of subject completion or withdrawal

Datatyp

date

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

withdrawn

Datatyp

boolean

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

If Yes, tick the primary reason for withdrawal

Datatyp

text

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

Investigator comment log

CRF page number if applicable
Beskrivning

CRF page number

Datatyp

integer

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

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Investigators Signature
Beskrivning

Investigators Signature

Alias
UMLS CUI-1
C1519316
Date of Signature
Beskrivning

Date of Signature

Datatyp

date

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

Printed Investigator's name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Additional Forms

1 Formulär
  1. StudyEvent: ODM
    1. Additional Forms
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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