ID

42082

Beschreibung

Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Stichworte

Versionen (2)
  1. 29.03.21 29.03.21 -
  2. 29.03.21 29.03.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. März 2021

DOI

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Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758

Englisch

Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site Number
Beschreibung

Site Number

Datentyp

text

Alias
UMLS CUI [1,1]
C2825164
UMLS CUI [1,2]
C0237753
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Series Page
Beschreibung

Series Page

Datentyp

text

Alias
UMLS CUI [1,1]
C0205549
UMLS CUI [1,2]
C1704732
Infection Summary
Beschreibung

Infection Summary

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C1706244
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) requiring oral or intravenous anti-infectives during study participation?
Beschreibung

If No, do not complete remainder of form. If Yes, complete remainder of form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0243026
UMLS CUI [3]
C0032285
UMLS CUI [4,1]
C2603343
UMLS CUI [4,2]
C0679823
If no invasive infection, record date of visit
Beschreibung

If no invasive infection, record date of visit

Datentyp

date

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C1320303
If invasive infection, enter date of infection
Beschreibung

If invasive infection, enter date of infection

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205281
UMLS CUI [2]
C0011008
Type of Infection
Beschreibung

Type of Infection

Datentyp

integer

Alias
UMLS CUI [1]
C0457463
Specify other type of infection
Beschreibung

Specify other type of infection

Datentyp

text

Alias
UMLS CUI [1,1]
C0457463
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Method of confirmation
Beschreibung

Method of confirmation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0025663
Specify other method of confirmation
Beschreibung

Specify other method of confirmation

Datentyp

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0025663
UMLS CUI [2]
C2348235
UMLS CUI [3]
C0205394
Was a culture obtained?
Beschreibung

If Yes, complete remaining culture information

Datentyp

boolean

Alias
UMLS CUI [1]
C0430400
Infection Summary - Culture information
Beschreibung

Infection Summary - Culture information

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C1706244
UMLS CUI-3
C0430400
UMLS CUI-4
C1533716
Source Code
Beschreibung

Source Code

Datentyp

integer

Alias
UMLS CUI [1]
C1710131
Specify other source code
Beschreibung

Specify other source code

Datentyp

text

Alias
UMLS CUI [1]
C1710131
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Culture Date
Beschreibung

Culture Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C0011008
Culture Result
Beschreibung

Culture Result

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430400
UMLS CUI [1,2]
C1274040
If positive result, indicate organism code
Beschreibung

If positive result, indicate organism code

Datentyp

integer

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0029235
UMLS CUI [2,2]
C0805701
Specify other organism
Beschreibung

Specify other organism

Datentyp

text

Alias
UMLS CUI [1]
C0029235
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Infection Summary - Anti-infective
Beschreibung

Infection Summary - Anti-infective

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C1706244
UMLS CUI-3
C0003204
Was an anti-infective administered?
Beschreibung

If Yes, list here and on the concomitant Medications form.

Datentyp

boolean

Alias
UMLS CUI [1]
C0003204
Infection Summary - Anti-infective
Beschreibung

Infection Summary - Anti-infective

Alias
UMLS CUI-1
C0009450
UMLS CUI-2
C1706244
UMLS CUI-3
C0003204
Anti-Infective
Beschreibung

Anti-Infective

Datentyp

text

Alias
UMLS CUI [1]
C0003204
Route
Beschreibung

IV or PO

Datentyp

integer

Alias
UMLS CUI [1]
C0013153
Empiric or therapeutic?
Beschreibung

Empiric or therapeutic?

Datentyp

integer

Alias
UMLS CUI [1]
C1880496
UMLS CUI [2]
C0302350
Anti-infective therapy start date
Beschreibung

Anti-infective therapy start date

Datentyp

date

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C0808070
Anti-infective therapy stop date
Beschreibung

Anti-infective therapy stop date

Datentyp

date

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C0806020
Anti-infective therapy ongoing?
Beschreibung

Anti-infective therapy ongoing?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C0549178
Concomitant Medications and Transfusions
Beschreibung

Concomitant Medications and Transfusions

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C1879316
Drug or Blood Product
Beschreibung

Drug or Blood Product

Datentyp

text

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0456388
Medication Dose
Beschreibung

Medication Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Medication Unit
Beschreibung

Medication Unit

Datentyp

text

Alias
UMLS CUI [1]
C2826646
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 Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
Medication Stop Date
Beschreibung

Medication Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
Medication Continuing?
Beschreibung

Medication Continuing?

Datentyp

text

Alias
UMLS CUI [1]
C2826666
Adverse Experiences
Beschreibung

Adverse Experiences

Alias
UMLS CUI-1
C0877248
No Adverse Experience
Beschreibung

No Adverse Experience

Datentyp

integer

Alias
UMLS CUI [1]
C0877248
Adverse Experiences
Beschreibung

Adverse Experiences

Alias
UMLS CUI-1
C0877248
Adverse Experience Number
Beschreibung

Adverse Experience Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0237753
Adverse Experience
Beschreibung

Adverse Experience

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Experience Grade
Beschreibung

Adverse Experience Grade

Datentyp

text

Alias
UMLS CUI [1]
C2985911
SAE?
Beschreibung

SERIOUS: Fatal or immediately life-threatening, permanently disabling, requires or prolongs hospitalization, congenital anomaly,cancer,or overdose

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Adverse Experience Onset Date
Beschreibung

Adverse Experience Onset Date

Datentyp

date

Alias
UMLS CUI [1]
C2985916
Adverse Experience Stop Date
Beschreibung

Adverse Experience Stop Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Adverse Experience Ongoing
Beschreibung

Adverse Experience Ongoing

Datentyp

text

Alias
UMLS CUI [1]
C2826663
Therapeutic Measures - Drug
Beschreibung

Therapeutic Measures - Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013227
Other therapeutic measures
Beschreibung

Record all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079809
UMLS CUI [1,3]
C0205394
Specify other therapeutic measure
Beschreibung

Specify other therapeutic measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079809
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Adverse Experience Outcome
Beschreibung

Adverse Experience Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Adverse Experience Relationship to Drug
Beschreibung

Adverse Experience Relationship to Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0439849
Adverse Experiences - Investigator Signature
Beschreibung

Adverse Experiences - Investigator Signature

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2346576
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site Number
Item
Site Number
text
C2825164 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Series Page
Item
Series Page
text
C0205549 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Item Group
Infection Summary
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) requiring oral or intravenous anti-infectives during study participation?
Item
Has the patient had a presumed or confirmed invasive infection (e.g., sepsis, pneumonia, etc.) requiring oral or intravenous anti-infectives during study participation?
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C2603343 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
If no invasive infection, record date of visit
Item
If no invasive infection, record date of visit
date
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1320303 (UMLS CUI [2])
If invasive infection, enter date of infection
Item
If invasive infection, enter date of infection
datetime
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Item
Type of Infection
integer
C0457463 (UMLS CUI [1])
Type of Infection
Code List
Type of Infection
CL Item
Meningitis (1)
CL Item
Pyelonephritis (2)
CL Item
Sepsis (3)
CL Item
Pneumonia (4)
CL Item
Endocarditis/Pericarditis (5)
CL Item
Peritonitis (6)
CL Item
Other (7)
Specify other type of infection
Item
Specify other type of infection
text
C0457463 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Method of confirmation
integer
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
Method of confirmation
Code List
Method of confirmation
CL Item
PE (1)
CL Item
CT Scan (2)
CL Item
X-ray (3)
CL Item
Other (4)
Specify other method of confirmation
Item
Specify other method of confirmation
text
C0750484 (UMLS CUI [1,1])
C0025663 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
Was a culture obtained?
Item
Was a culture obtained?
boolean
C0430400 (UMLS CUI [1])
Item Group
Infection Summary - Culture information
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0430400 (UMLS CUI-3)
C1533716 (UMLS CUI-4)
Item
Source Code
integer
C1710131 (UMLS CUI [1])
Source Code
Code List
Source Code
CL Item
Sputum (1)
CL Item
Blood (2)
CL Item
Throat (3)
CL Item
Skin (4)
CL Item
CSF (5)
CL Item
Urine (6)
CL Item
Stool (7)
CL Item
Abscess (8)
CL Item
Other, specify (9)
Specify other source code
Item
Specify other source code
text
C1710131 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Culture Date
Item
Culture Date
date
C0430400 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Culture Result
integer
C0430400 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Culture Result
Code List
Culture Result
CL Item
Pos (1)
CL Item
Neg (2)
Item
If positive result, indicate organism code
integer
C1274040 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0029235 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
If positive result, indicate organism code
Code List
If positive result, indicate organism code
CL Item
Herpes simplex (1)
CL Item
Staph. aureus (2)
CL Item
Staph. epidermis (3)
CL Item
E. coli (4)
CL Item
Candida albicans (5)
CL Item
Strep. pneumoniae (6)
CL Item
Pseudomonas aeruginosa (7)
CL Item
Listeria monocytogenes (8)
CL Item
Varicella-zoster (9)
CL Item
Pneumocytis carinii (10)
CL Item
Cytomegalovirus (11)
CL Item
Other, specify (12)
Specify other organism
Item
Specify other organism
text
C0029235 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Infection Summary - Anti-infective
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
Was an anti-infective administered?
Item
Was an anti-infective administered?
boolean
C0003204 (UMLS CUI [1])
Item Group
Infection Summary - Anti-infective
C0009450 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
C0003204 (UMLS CUI-3)
Anti-Infective
Item
Anti-Infective
text
C0003204 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
IV (1)
CL Item
PO (2)
Item
Empiric or therapeutic?
integer
C1880496 (UMLS CUI [1])
C0302350 (UMLS CUI [2])
Empiric or therapeutic?
Code List
Empiric or therapeutic?
CL Item
Empiric (1)
CL Item
Therapeutic (2)
Anti-infective therapy start date
Item
Anti-infective therapy start date
date
C1141958 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Anti-infective therapy stop date
Item
Anti-infective therapy stop date
date
C1141958 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Anti-infective therapy ongoing?
integer
C1141958 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Anti-infective therapy ongoing?
Code List
Anti-infective therapy ongoing?
CL Item
ongoing (1)
Item Group
Concomitant Medications and Transfusions
C2347852 (UMLS CUI-1)
C1879316 (UMLS CUI-2)
Drug or Blood Product
Item
Drug or Blood Product
text
C0013227 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Medication Dose
Item
Medication Dose
text
C3174092 (UMLS CUI [1])
Medication Unit
Item
Medication Unit
text
C2826646 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication Frequency
Item
Medication Frequency
text
C3476109 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication Stop Date
Item
Medication Stop Date
date
C2826744 (UMLS CUI [1])
Item
Medication Continuing?
text
C2826666 (UMLS CUI [1])
Medication Continuing?
Code List
Medication Continuing?
CL Item
Continuing (C)
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Item
No Adverse Experience
integer
C0877248 (UMLS CUI [1])
No Adverse Experience
Code List
No Adverse Experience
CL Item
No Adverse Experience (1)
Item Group
Adverse Experiences
C0877248 (UMLS CUI-1)
Adverse Experience Number
Item
Adverse Experience Number
integer
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse Experience
Item
Adverse Experience
text
C0877248 (UMLS CUI [1])
Adverse Experience Grade
Item
Adverse Experience Grade
text
C2985911 (UMLS CUI [1])
SAE?
Item
SAE?
boolean
C1519255 (UMLS CUI [1])
Adverse Experience Onset Date
Item
Adverse Experience Onset Date
date
C2985916 (UMLS CUI [1])
Adverse Experience Stop Date
Item
Adverse Experience Stop Date
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Adverse Experience Ongoing
text
C2826663 (UMLS CUI [1])
Adverse Experience Ongoing
Code List
Adverse Experience Ongoing
CL Item
Continuing (C)
Item
Therapeutic Measures - Drug
integer
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Therapeutic Measures - Drug
Code List
Therapeutic Measures - Drug
CL Item
None (1)
CL Item
Infusion rate slowed (2)
CL Item
Infusion stopped permanently (3)
Item
Other therapeutic measures
integer
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other therapeutic measures
Code List
Other therapeutic measures
CL Item
None (1)
CL Item
Uncertain (2)
CL Item
Procedure or physical therapy (3)
CL Item
Blood or blood products (4)
CL Item
Withdrawn from study (5)
CL Item
Prescription drug therapy (6)
CL Item
Non-prescription drug therapy (7)
CL Item
Hospitalization (8)
CL Item
IV Fluids (9)
CL Item
Other, specify (99)
Specify other therapeutic measure
Item
Specify other therapeutic measure
text
C0087111 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Adverse Experience Outcome
integer
C1705586 (UMLS CUI [1])
Adverse Experience Outcome
Code List
Adverse Experience Outcome
CL Item
Complete recovery (1)
CL Item
Death (2)
CL Item
Unknown/ lost to follow-up (3)
CL Item
AE persisting (4)
Item
Adverse Experience Relationship to Drug
integer
C0877248 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Adverse Experience Relationship to Drug
Code List
Adverse Experience Relationship to Drug
CL Item
None (1)
CL Item
Remote (2)
CL Item
Possible (3)
CL Item
Probable (4)
CL Item
Highly Probable (5)
Item Group
Adverse Experiences - Investigator Signature
C0877248 (UMLS CUI-1)
C2346576 (UMLS CUI-2)
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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