ID

37972

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Keywords

  1. 9/3/19 9/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Are there any non-serious adverse events to report?
Description

Are there any non-serious adverse events to report?

Alias
UMLS CUI-1
C1518404
Are there any non-serious adverse events to report?
Description

If yes, record any adverse events (using standard medical terminology) observed or elicited by the following direct question to patient: Do you feel different in any way since starting the treatment or since the last visit? Provide the diagnosis, not symptoms, where possible. Record only one adverse event per column.

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious adverse Events
Description

Non-Serious adverse Events

Alias
UMLS CUI-1
C1518404
Non-Serious adverse Event
Description

Non-Serious adverse Event

Data type

text

Alias
UMLS CUI [1]
C1518404
Non-Serious adverse Event Onset Date
Description

Non-Serious adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1518404
Non-Serious adverse Event End Date
Description

Non-Serious adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-serious adverse Event Outcome
Description

(If died, STOP; go to SAE section and follow instructions)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Non-Serious adverse Event Experience Course
Description

Non-Serious adverse Event Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
Non-Serious adverse Event Common Toxicity Grade
Description

Non-Serious adverse Event Common Toxicity Grade

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826262
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
Description

Non-Serious adverse Event - Action Taken with Respect to investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826626
Non-Serious adverse Event - Relationship to Investigational Drug
Description

Non-Serious adverse Event - Relationship to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Non-Serious adverse Event - Corrective Therapy
Description

If yes, record details in Concomitant Medication section

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

Was patient withdrawn due to this specific AE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Serious Adverse Event #1
Description

Serious Adverse Event #1

Alias
UMLS CUI-1
C1519255
Serious Adverse Event
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Person Reporting SAE:
Description

Person Reporting SAE:

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
Serious Adverse Event Onset Date
Description

Serious Adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C1519255
Serious Adverse Event Onset Time
Description

Serious Adverse Event Onset Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449244
Serious Adverse Event End Date
Description

Serious Adverse Event End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Serious Adverse Event End Time
Description

Serious Adverse Event End Time

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
Specify reason(s) for considering this an SAE.
Description

Mark all that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
If other reason(s) for considering this an SAE, specify
Description

If other reason(s) for considering this an SAE, specify

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Serious Adverse Event Outcome
Description

Serious Adverse Event Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Serious Adverse Event - Experience Course
Description

Serious Adverse Event - Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Serious Adverse Event - Common Toxicity Grade
Description

Serious Adverse Event - Common Toxicity Grade

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826262
Serious Adverse Event - Action Taken with Respect to Investigational Drug
Description

Serious Adverse Event - Action Taken with Respect to Investigational Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826626
Did the SAE abate?
Description

Did the SAE abate?

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Description

If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707811
If study Medication was reintroduced, did SAE recur?
Description

If study Medication was reintroduced, did SAE recur?

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1707811
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0034897
Serious Adverse Event - Relationship to Investigatinoal Drug
Description

Serious Adverse Event - Relationship to Investigatinoal Drug

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
If Relationship to Investigational Product is "Unrelated" or "Probably Unrelated", the SAE is propably associated with...
Description

Mark one

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
UMLS CUI [2]
C0445356
UMLS CUI [3]
C0332281
If SAE is associated with Protocol design or procedures, specify
Description

If SAE is associated with Protocol design or procedures, specify

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C2348235
If SAE ist associated with another condition, specify
Description

If SAE ist associated with another condition, specify

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0332281
UMLS CUI [1,5]
C2348235
If SAE is associated with another Drug, specify
Description

If SAE is associated with another Drug, specify

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0332281
UMLS CUI [1,5]
C2348235
Serious Adverse Event - Corrective Therapy
Description

If yes, record details in Concomitant Medication section

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific SAE?
Description

Was patient withdrawn due to this specific SAE?

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
Serious Adverse Event - Remarks
Description

Please provide a brief narrative description of he SAE, attaching extra pages e.g., hospital discharge summary if necessary.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Serious Adverse Event #1 - Relevant Laboratory Data
Description

Serious Adverse Event #1 - Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0587081
Laboratory Test
Description

Laboratory Test

Data type

text

Alias
UMLS CUI [1]
C0022885
Laboratory Test Date
Description

Laboratory Test Date

Data type

date

Alias
UMLS CUI [1]
C2826641
Laboratory Test Value
Description

Laboratory Test Value

Data type

text

Alias
UMLS CUI [1]
C0587081
Laboratory Test Units
Description

Laboratory Test Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Laboratory Test Normal Range
Description

Laboratory Test Normal Range

Data type

text

Alias
UMLS CUI [1]
C1096215
Serious Adverse Event #1 - Signature
Description

Serious Adverse Event #1 - Signature

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2346576
Serious Adverse Event - Investigator's Signature
Description

Confirming above data are accurate and complete.^

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
Investigator's Name
Description

Investigator's Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator's Siganture Date Signed
Description

Investigator's Siganture Date Signed

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Medical Monitor‘s Signature
Description

Medical Monitor‘s Signature

Data type

text

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1519316
Medical Monitor's Name
Description

Medical Monitor's Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Medical Monitors Signature Date Signed
Description

Medical Monitors Signature Date Signed

Data type

date

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0011008
Prior and Concomitant Medications
Description

Prior and Concomitant Medications

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Were any Medications taken by the patient up to 14 days prior to first administration of study medication and/or during the study?
Description

If "Yes", provide information below.

Data type

boolean

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
Prior and Concomitant Medications
Description

Prior and Concomitant Medications

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Line Number
Description

Line Number

Data type

integer

Alias
UMLS CUI [1]
C0449788
Medication Generic Name
Description

If a combmation drug, use Trade name.

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0592502
Medication Dose
Description

Medication Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Medication Units
Description

Medication Units

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1519795
Medication Route
Description

Medication Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Medication Frequency
Description

Medication Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Medication Indication
Description

Medication Indication

Data type

text

Alias
UMLS CUI [1]
C2826696
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Medication prior to study medication
Description

Medication prior to study medication

Data type

integer

Alias
UMLS CUI [1]
C2826257
UMLS CUI [2]
C0304229
Concomitant Medication
Description

Concomitant Medication

Data type

integer

Alias
UMLS CUI [1]
C2347852
Medication Start Date
Description

Medication Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication End Date
Description

Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
OR Ongoing at end of study
Description

OR Ongoing at end of study

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178

Similar models

Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item Group
Are there any non-serious adverse events to report?
C1518404 (UMLS CUI-1)
Are there any non-serious adverse events to report?
Item
Are there any non-serious adverse events to report?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious adverse Events
C1518404 (UMLS CUI-1)
Non-Serious adverse Event
Item
Non-Serious adverse Event
text
C1518404 (UMLS CUI [1])
Non-Serious adverse Event Onset Date
Item
Non-Serious adverse Event Onset Date
date
C2985916 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Non-Serious adverse Event End Date
Item
Non-Serious adverse Event End Date
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-serious adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-serious adverse Event Outcome
CL Item
Resolved (1)
CL Item
Ongoing (at end of study) (2)
CL Item
Deíed --> see SAE section (3)
Item
Non-Serious adverse Event Experience Course
integer
C1518404 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Non-Serious adverse Event Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Non-Serious adverse Event Common Toxicity Grade
Item
Non-Serious adverse Event Common Toxicity Grade
integer
C1518404 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Code List
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
CL Item
None  (1)
CL Item
Dose reduced  (2)
CL Item
Drug interrupted/restarted  (3)
CL Item
Drug stopped  (4)
CL Item
Dose delayed  (5)
CL Item
Dose delayed and reduced (6)
Item
Non-Serious adverse Event - Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Non-Serious adverse Event - Relationship to Investigational Drug
CL Item
Unretated  (1)
CL Item
Probably Unrelated  (2)
CL Item
Possibly Related  (3)
CL Item
Reslated (4)
Non-Serious adverse Event - Corrective Therapy
Item
Non-Serious adverse Event - Corrective Therapy
boolean
C1518404 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific AE?
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
Serious Adverse Event #1
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Person Reporting SAE:
Item
Person Reporting SAE:
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Date
Item
Serious Adverse Event Onset Date
date
C2985916 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Onset Time
Item
Serious Adverse Event Onset Time
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
Serious Adverse Event End Date
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
Serious Adverse Event End Time
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this an SAE.
integer
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this an SAE.
CL Item
Results in death  (1)
CL Item
Life threatening  (2)
CL Item
Results in hospitalization or prolongation of existing hospitalization  (3)
CL Item
Results in disability / incapacity  (4)
CL Item
Congenital abnormality / birth defect  (5)
CL Item
Other (see definition), specify: (6)
If other reason(s) for considering this an SAE, specify
Item
If other reason(s) for considering this an SAE, specify
text
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Serious Adverse Event Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Serious Adverse Event Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (Complete Patient Form D) (3)
Item
Serious Adverse Event - Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Serious Adverse Event - Experience Course
CL Item
Intermittent (1)
CL Item
Consatant (2)
Serious Adverse Event - Common Toxicity Grade
Item
Serious Adverse Event - Common Toxicity Grade
integer
C1519255 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Item
Serious Adverse Event - Action Taken with Respect to Investigational Drug
integer
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Code List
Serious Adverse Event - Action Taken with Respect to Investigational Drug
CL Item
None  (1)
CL Item
Dose reduced (2)
CL Item
Drug interrupted/restarted  (3)
CL Item
Drug stopped  (4)
CL Item
Dose delayed  (5)
CL Item
Dose delayed and reduced (6)
Did the SAE abate?
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Item
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
If study Medication was reintroduced, did SAE recur?
Item
If study Medication was reintroduced, did SAE recur?
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
Item
Serious Adverse Event - Relationship to Investigatinoal Drug
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Serious Adverse Event - Relationship to Investigatinoal Drug
CL Item
Unrelated (1)
CL Item
Propably Unrelated (2)
CL Item
Possibly Related (3)
CL Item
Related (4)
Item
If Relationship to Investigational Product is "Unrelated" or "Probably Unrelated", the SAE is propably associated with...
integer
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0445356 (UMLS CUI [2])
C0332281 (UMLS CUI [3])
Code List
If Relationship to Investigational Product is "Unrelated" or "Probably Unrelated", the SAE is propably associated with...
CL Item
Protocol design of procedures (but not to study drug), specify (1)
CL Item
Another condition (e.g., condition under study, intercurrent illness), specify (2)
CL Item
Another Drug, specify (3)
If SAE is associated with Protocol design or procedures, specify
Item
If SAE is associated with Protocol design or procedures, specify
text
C1519255 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If SAE ist associated with another condition, specify
Item
If SAE ist associated with another condition, specify
text
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
If SAE is associated with another Drug, specify
Item
If SAE is associated with another Drug, specify
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Serious Adverse Event - Corrective Therapy
Item
Serious Adverse Event - Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Was patient withdrawn due to this specific SAE?
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event - Remarks
Item
Serious Adverse Event - Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Serious Adverse Event #1 - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Laboratory Test Date
Item
Laboratory Test Date
date
C2826641 (UMLS CUI [1])
Laboratory Test Value
Item
Laboratory Test Value
text
C0587081 (UMLS CUI [1])
Laboratory Test Units
Item
Laboratory Test Units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Laboratory Test Normal Range
Item
Laboratory Test Normal Range
text
C1096215 (UMLS CUI [1])
Item Group
Serious Adverse Event #1 - Signature
C1519255 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Serious Adverse Event - Investigator's Signature
Item
Serious Adverse Event - Investigator's Signature
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Investigator's Siganture Date Signed
Item
Investigator's Siganture Date Signed
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Medical Monitor‘s Signature
Item
Medical Monitor‘s Signature
text
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Medical Monitor's Name
Item
Medical Monitor's Name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Medical Monitors Signature Date Signed
Item
Medical Monitors Signature Date Signed
date
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Prior and Concomitant Medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Were any Medications taken by the patient up to 14 days prior to first administration of study medication and/or during the study?
Item
Were any Medications taken by the patient up to 14 days prior to first administration of study medication and/or during the study?
boolean
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Prior and Concomitant Medications
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Line Number
Item
Line Number
integer
C0449788 (UMLS CUI [1])
Medication Generic Name
Item
Medication Generic Name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Medication Dose
Item
Medication Dose
text
C3174092 (UMLS CUI [1])
Medication Units
Item
Medication Units
text
C0013227 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Indication
Item
Medication Indication
text
C2826696 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Item
Medication prior to study medication
integer
C2826257 (UMLS CUI [1])
C0304229 (UMLS CUI [2])
Code List
Medication prior to study medication
CL Item
Yes (1)
Item
Concomitant Medication
integer
C2347852 (UMLS CUI [1])
Code List
Concomitant Medication
CL Item
Yes (1)
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
OR Ongoing at end of study
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
OR Ongoing at end of study
CL Item
Yes (1)

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