Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
boolean
C0042210 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Trade / Generic Name
Item
Trade / Generic Name
text
C0042196 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
Concomitant vaccination Administration date
Item
Concomitant vaccination Administration date
date
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Have any of the above mentioned medications/treatments been administered during study period?
Item
Have any of the above mentioned medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
Medication Trade / Generic Name
Item
Medication Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0592502 (UMLS CUI [2,2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Medical Indication
Medication total daily dose
Item
Medication total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
Medication Route
Item
Medication Route
text
C0013153 (UMLS CUI [1])
Medication start date
Item
Medication start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication stop date
Item
Medication stop date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Medication continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Code List
Medication continuing at end of study
CL Item
Medication continuing (1)
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2])
Non-serious adverse event number
Item
Non-serious adverse event number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Description
Item
Non-serious adverse event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-serious adverse event site / Vaccine
integer
C1518404 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Code List
Non-serious adverse event site / Vaccine
CL Item
Local (administration sites) (1)
CL Item
Liquid PedvaxHIB (113)
CL Item
Comvax Vaccine (172)
CL Item
General (non administration site) (2)
Non-serious adverse event start date
Item
Non-serious adverse event start date
date
C2697888 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious advers event started during immediate post-vaccination period specified in protocol
integer
C1518404 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2348563 (UMLS CUI [3])
Code List
Non-serious advers event started during immediate post-vaccination period specified in protocol
CL Item
during immediate post-vaccination period (1)
Date non-serious adverse event stopped
Item
Date non-serious adverse event stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-serious adverse event intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Non-serious adverse event intensity
In your opinion, did the vaccine possibly contribute to this AE?
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
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
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
Item
Serious adverse event
integer
C1519255 (UMLS CUI [1])
Code List
Serious adverse event
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])
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])
Subject Demography - Date of Birth
Item
Subject Demography - Date of Birth
date
C0011298 (UMLS CUI [1])
C0421451 (UMLS CUI [2])
Item
Subject Demography - Gender
text
C0011298 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Code List
Subject Demography - Gender
Adverse Event Diagnosis
Item
Adverse Event Diagnosis
text
C0877248 (UMLS CUI [1,1])
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])
SAE - Date and time stopped
Item
SAE - Date and time stopped
datetime
C1519255 (UMLS CUI [1,1])
C2826793 (UMLS CUI [1,2])
Item
SAE - Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Intensity
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])
Item
SAE - Other possible contributors
integer
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
SAE - Other possible contributors
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])
Item
SAE - Outcome
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
CL Item
Recovered with sequelae (2)
Item
SAE - Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
SAE - Action taken with respect to Study Vaccine
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])
Code List
SAE - Events after further vaccination
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])
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])
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])
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])
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])
If
Item
If "medically important" event, specify
text
C1519255 (UMLS CUI [1,1])
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])
Code List
Other events (not SAE) to be reported in the same way
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])
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])
Vaccine Lot No
Item
Vaccine Lot No
text
C2826710 (UMLS CUI [1,1])
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])
Study Vaccine Date
Item
Study Vaccine Date
date
C0042210 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Drug/ vaccine
Item
Drug/ vaccine
text
C2347852 (UMLS CUI [1])
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])
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])
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])
Drug for SAE - Dosage
Item
Drug for SAE - Dosage
text
C1519255 (UMLS CUI [1,1])
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])
Drug for SAE - Route
Item
Drug for SAE - Route
text
C0013153 (UMLS CUI [1,1])
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])
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])
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])
SAE- Description
Item
SAE- Description
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE - Comments
Item
SAE - Comments
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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])
Signature Clinical Development Manager
Item
Signature Clinical Development Manager
text
C1519316 (UMLS CUI [1,1])
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])
Clinical Development Manager
Item
Signature Clinical Development Manager Signature Date
date
C1519316 (UMLS CUI [1,1])
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])