Informações:
Falhas:
ID
38448
Descrição
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Palavras-chave
Versões (1)
- 17/10/2019 17/10/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
17 de outubro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)
Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up
Similar models
Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Would the subject be willing to participate in a follow-up study?
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,2])
Item
If subject would not be willing to participate in a follow-up study, specify the reason
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Code List
If subject would not be willing to participate in a follow-up study, specify the reason
CL Item
Adverse Events, or Serious Adverse Eventsm please specify (1)
CL Item
Other, please specify (2)
If reason is Adverse Event, or Serious Adverse Event, please specify
Item
If reason is Adverse Event, or Serious Adverse Event, please specify
text
C0566251 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Has the code been broken?
Item
Has the code been broken?
boolean
C0008972 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
If any elimination criteria become applicabe during the study, please specify.
Item
If any elimination criteria become applicabe during the study, please specify.
text
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C1706839 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Has the subject dropped out of the study?
Item
Has the subject dropped out of the study?
boolean
C2348568 (UMLS CUI [1])
Item
If subject dropped out, please mark the one most appropriate category for drop out
text
C2348568 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
Code List
If subject dropped out, please mark the one most appropriate category for drop out
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event form) (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (OTH)
Please specify Adverse event number
Item
Please specify Adverse event number
text
C0877248 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Please specify protocol violation.
Item
Please specify protocol violation.
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
If other reason for drop out, please specify.
Item
If other reason for drop out, please specify.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Signature date
Item
Signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Tracking Document Safety Follow-Up
C3889409 (UMLS CUI-1)
C1522577 (UMLS CUI-3)
C0036043 (UMLS CUI-4)
C1522577 (UMLS CUI-3)
C0036043 (UMLS CUI-4)
CL Item
Prospective Follow-Up for all subjects (1)
CL Item
Retrospective Safety Follow-Up (time elapsed between the last contact of the preceding study and the new study contact as (2)
CL Item
specified in the protocol.) (3)
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Signature Date
Item
Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Tracking Document Safety Follow-Up
C3889409 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Did the subject experience any SAE(s) since the last contact?
integer
C1519255 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C1705415 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Code List
Did the subject experience any SAE(s) since the last contact?
CL Item
Yes, please complete the Safety Follow-up Serious Adverse Event SAE) form (1)
CL Item
No (2)
CL Item
Unknown (subject lost to follow-up or could not be reached) (3)
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up - Administrative
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
Protocol
Item
Protocol
text
C2348563 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
CL Item
Initial report (1)
CL Item
Additional info (2)
CL Item
Additional info (3)
CL Item
Additional info (4)
Subject Demography - Initials - First name
Item
Subject Demography - Initials - First name
text
C0011298 (UMLS CUI [1])
C2986440 (UMLS CUI [2,1])
C1443235 (UMLS CUI [2,2])
C2986440 (UMLS CUI [2,1])
C1443235 (UMLS CUI [2,2])
Subject Demography - Initials - Last name
Item
Subject Demography - Initials - Last name
text
C0011298 (UMLS CUI [1])
C2986440 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
C2986440 (UMLS CUI [2,1])
C1301584 (UMLS CUI [2,2])
Subject Demography - Date of Birth
Item
Subject Demography - Date of Birth
date
C0011298 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
C0421451 (UMLS CUI [2])
Item
Subject Demography - Gende
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
CL Item
Female (F)
CL Item
Male (M)
Adverse Event Diagnosis
Item
Adverse Event Diagnosis
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
SAE - Date and time started
Item
SAE - Date and time started
datetime
C1519255 (UMLS CUI [1,1])
C2826806 (UMLS CUI [1,2])
C2826806 (UMLS CUI [1,2])
SAE - Date and time stopped
Item
SAE - Date and time stopped
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
C2826793 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
In your opinion, did the vaccine possibly contribute to the SAE
Item
In your opinion, did the vaccine possibly contribute to the SAE
boolean
C1519255 (UMLS CUI [1,1])
C1880177 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1880177 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
SAE - Other possible contributors
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
CL Item
Medical history (1)
CL Item
Other medication (2)
CL Item
Protocol required procedure (3)
CL Item
Other procedure (4)
CL Item
Lack of efficacy (5)
CL Item
Erroneous administration (6)
CL Item
Other, specify (7)
SAE - If other possible contributors, specify
Item
SAE - If other possible contributors, specify
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing (3)
CL Item
Died (4)
Item
SAE - Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Action taken with respect to Study Vaccine
CL Item
None (1)
CL Item
Vaccination course postponed (2)
CL Item
Vaccination course stopped (3)
Item
SAE - Events after further vaccination
integer
C0035020 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
CL Item
Event reappeared (1)
CL Item
Event did not reappear (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Specify criteria for considering this as a Serious Adverse Event
integer
C1519255 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,2])
Code List
Specify criteria for considering this as a Serious Adverse Event
CL Item
Result in death (1)
CL Item
Life threatening (2)
CL Item
Result in persistent or significant disability/ incapacity (3)
CL Item
Requires in-patienthospitalization (4)
CL Item
Prolongation of existing hospitalization (5)
CL Item
Congenital anomaly/ birth defect in the offspring of a study subject (6)
CL Item
"Medically important" event, specify (7)
If SAE resulted in death, was autopsy performed?
Item
If SAE resulted in death, was autopsy performed?
boolean
C0004398 (UMLS CUI [1,1])
C1320832 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1320832 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required in-patient hospitalization, enter admission date
Item
If SAE required in-patient hospitalization, enter admission date
date
C2826664 (UMLS CUI [1,1])
C1302393 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1302393 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required in-patient hospitalization, enter discharge date
Item
If SAE required in-patient hospitalization, enter discharge date
date
C2826664 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If SAE required prolongation of existing hospitalization, enter discharge date
Item
If SAE required prolongation of existing hospitalization, enter discharge date
date
C0745041 (UMLS CUI [1,1])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2361123 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
If "medically important" event, specify
Item
If "medically important" event, specify
text
C1519255 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C3898777 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Other events (not SAE) to be reported in the same way
integer
C0441471 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
Code List
Other events (not SAE) to be reported in the same way
CL Item
Cancer (1)
Was subject withdrawn due to this specific SAE?
Item
Was subject withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Study vaccine information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0042210 (UMLS CUI-5)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0042210 (UMLS CUI-5)
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Vaccine Dose No
Item
Vaccine Dose No
text
C3174092 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine Lot No
Item
Vaccine Lot No
text
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Vaccine Route/ Site
Item
Vaccine Route/ Site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0013153 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Study Vaccine Date
Item
Study Vaccine Date
date
C0042210 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2347852 (UMLS CUI-5)
C0042210 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C0085978 (UMLS CUI-8)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2347852 (UMLS CUI-5)
C0042210 (UMLS CUI-6)
C1519255 (UMLS CUI-7)
C0085978 (UMLS CUI-8)
Drug/ vaccine
Item
Drug/ vaccine
text
C2347852 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
C0042210 (UMLS CUI [2])
Medication dosage
Item
Medication dosage
text
C3174092 (UMLS CUI [1])
Medication frequency
Item
Medication frequency
text
C3476109 (UMLS CUI [1])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication start date
Item
Medication start date
date
C2826734 (UMLS CUI [1])
Medication end date
Item
Medication end date
date
C2826744 (UMLS CUI [1])
Item Group
Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C3640977 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0262926 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C1519255 (UMLS CUI-9)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C3640977 (UMLS CUI-4)
C1880177 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C0262926 (UMLS CUI-7)
C1880177 (UMLS CUI-8)
C1519255 (UMLS CUI-9)
Condition
Item
Condition
text
C0012634 (UMLS CUI [1])
Condition still present?
Item
Condition still present?
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Drug(s) used to treat this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0087111 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0087111 (UMLS CUI-5)
C1519255 (UMLS CUI-6)
Drug(s) used to treat this SAE
Item
Drug(s) used to treat this SAE
text
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Drug for SAE - Dosage
Item
Drug for SAE - Dosage
text
C1519255 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
Drug for SAE - Frequency
Item
Drug for SAE - Frequency
text
C3476109 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Drug for SAE - Route
Item
Drug for SAE - Route
text
C0013153 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Drug for SAE - Start date
Item
Drug for SAE - Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Drug for SAE - End date
Item
Drug for SAE - End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Serious adverse event safety follow-up - Surgical treatment for this SAE
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
Serious adverse event - Surgical treatment for this SAE
Item
Serious adverse event - Surgical treatment for this SAE
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Description
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
SAE- Description
Item
SAE- Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Comments
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
C1519255 (UMLS CUI-5)
SAE - Comments
Item
SAE - Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Serious adverse event safety follow-up - Investigator signature
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2346576 (UMLS CUI-4)
C1522577 (UMLS CUI-2)
C0036043 (UMLS CUI-3)
C2346576 (UMLS CUI-4)
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])
C0011008 (UMLS CUI [1,2])
Signature Clinical Development Manager
Item
Signature Clinical Development Manager
text
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
Clinical Development Manager Name
Item
Clinical Development Manager Name
text
C0027365 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
C0681803 (UMLS CUI [1,2])
Signature Clinical Development Manager Signature Date
Item
Signature Clinical Development Manager Signature Date
date
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0681803 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
AEGIS Number
Item
AEGIS Number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])