ID

37972

Beschreibung

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

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Versionen (1)
  1. 03.09.19 03.09.19 -
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GlaxoSmithKline

Hochgeladen am

3. September 2019

DOI

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

Englisch

Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Center Number

Datentyp

text

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Beschreibung

Patient ID

Datentyp

text

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

Are there any non-serious adverse events to report?

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

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.

Datentyp

boolean

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

Non-Serious adverse Events

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

Non-Serious adverse Event

Datentyp

text

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

Non-Serious adverse Event Onset Date

Datentyp

date

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

Non-Serious adverse Event End Date

Datentyp

date

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

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

Datentyp

integer

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

Non-Serious adverse Event Experience Course

Datentyp

integer

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

Non-Serious adverse Event Common Toxicity Grade

Datentyp

integer

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

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

Datentyp

integer

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

Non-Serious adverse Event - Relationship to Investigational Drug

Datentyp

integer

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

If yes, record details in Concomitant Medication section

Datentyp

boolean

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

Was patient withdrawn due to this specific AE?

Datentyp

boolean

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

Serious Adverse Event #1

Alias
UMLS CUI-1
C1519255
Serious Adverse Event
Beschreibung

Serious Adverse Event

Datentyp

text

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

Person Reporting SAE:

Datentyp

text

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

Serious Adverse Event Onset Date

Datentyp

date

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

Serious Adverse Event Onset Time

Datentyp

time

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

Serious Adverse Event End Date

Datentyp

date

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

Serious Adverse Event End Time

Datentyp

time

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

Mark all that apply

Datentyp

integer

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

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

Datentyp

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
Beschreibung

Serious Adverse Event Outcome

Datentyp

integer

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

Serious Adverse Event - Experience Course

Datentyp

integer

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

Serious Adverse Event - Common Toxicity Grade

Datentyp

integer

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

Serious Adverse Event - Action Taken with Respect to Investigational Drug

Datentyp

integer

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

Did the SAE abate?

Datentyp

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)?
Beschreibung

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

Datentyp

boolean

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

If study Medication was reintroduced, did SAE recur?

Datentyp

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
Beschreibung

Serious Adverse Event - Relationship to Investigatinoal Drug

Datentyp

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...
Beschreibung

Mark one

Datentyp

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
Beschreibung

If SAE is associated with Protocol design or procedures, specify

Datentyp

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
Beschreibung

If SAE ist associated with another condition, specify

Datentyp

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
Beschreibung

If SAE is associated with another Drug, specify

Datentyp

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
Beschreibung

If yes, record details in Concomitant Medication section

Datentyp

boolean

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

Was patient withdrawn due to this specific SAE?

Datentyp

boolean

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

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

Datentyp

text

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

Serious Adverse Event #1 - Relevant Laboratory Data

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

Laboratory Test

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Laboratory Test Date
Beschreibung

Laboratory Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826641
Laboratory Test Value
Beschreibung

Laboratory Test Value

Datentyp

text

Alias
UMLS CUI [1]
C0587081
Laboratory Test Units
Beschreibung

Laboratory Test Units

Datentyp

text

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

Laboratory Test Normal Range

Datentyp

text

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

Serious Adverse Event #1 - Signature

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

Confirming above data are accurate and complete.^

Datentyp

text

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

Investigator's Name

Datentyp

text

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

Investigator's Siganture Date Signed

Datentyp

date

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

Medical Monitor‘s Signature

Datentyp

text

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

Medical Monitor's Name

Datentyp

text

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

Medical Monitors Signature Date Signed

Datentyp

date

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

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?
Beschreibung

If "Yes", provide information below.

Datentyp

boolean

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

Prior and Concomitant Medications

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

Line Number

Datentyp

integer

Alias
UMLS CUI [1]
C0449788
Medication Generic Name
Beschreibung

If a combmation drug, use Trade name.

Datentyp

text

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

Medication Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Medication Units
Beschreibung

Medication Units

Datentyp

text

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

Medication Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Medication Frequency
Beschreibung

Medication Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Medication Indication
Beschreibung

Medication Indication

Datentyp

text

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

Medication prior to study medication

Datentyp

integer

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

Concomitant Medication

Datentyp

integer

Alias
UMLS CUI [1]
C2347852
Medication Start Date
Beschreibung

Medication Start Date

Datentyp

date

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

Medication End Date

Datentyp

date

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

OR Ongoing at end of study

Datentyp

integer

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

Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Non-serious adverse Event Outcome
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])
Non-Serious adverse Event Experience Course
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])
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
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])
Non-Serious adverse Event - Relationship to Investigational Drug
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])
Specify reason(s) for considering this an SAE.
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])
Serious Adverse Event Outcome
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])
Serious Adverse Event - Experience Course
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])
Serious Adverse Event - Action Taken with Respect to Investigational Drug
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])
Serious Adverse Event - Relationship to Investigatinoal Drug
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])
The SAE is propably associated with...
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])
Medication prior to study medication
Code List
Medication prior to study medication
CL Item
Yes (1)
Item
Concomitant Medication
integer
C2347852 (UMLS CUI [1])
Concomitant Medication
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])
OR Ongoing at end of study
Code List
OR Ongoing at end of study
CL Item
Yes (1)
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