English

Observation Class: Events - Domain: Medical History

59 forms  
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Medical History
Description

Medical History

Alias
SDTMIG v3.3
MH
UMLS CUI-1
C0262926
NCIt V19.10d:
C49603
Study Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Unique identifier for a study. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1]
C2826693
SDTMIG 3.3
STUDYID
NCIt V19.10d
C83082
Domain Abbreviation
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Two-character abbreviation for the domain. Controlled Terms or Format (if applicable): MH

Data type

text

Alias
UMLS CUI [1,1]
C1883204
UMLS CUI [1,2]
C0000723
SDTMIG 3.3
DOMAIN
NCIt V19.10d
C49556
Unique Subject Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C1710548
UMLS CUI [1,2]
C2826693
SDTMIG 3.3
USUBJID
NCIt V19.10d
C70731
Sequence Number
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2348184
SDTMIG 3.3
MHSEQ
NCIt V19.10d
C83336
Group ID
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Used to tie together a block of related records in a single domain for a subject. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0600091
SDTMIG 3.3
MHGRPID
NCIt V19.10d
C83332
Reference ID
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Internal or external medical history identifier. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826265
SDTMIG 3.3
MHREFID
NCIt V19.10d
C83332
Sponsor-Defined Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Medical History page. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2347796
UMLS CUI [1,3]
C0600091
SDTMIG 3.3
MHSPID
NCIt V19.10d
C83079
Reported Term for the Medical History
Description

Role: Topic CDISC Notes (for domains) Description (for General Classes): Verbatim or preprinted CRF term for the medical condition or event. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C0262926
SDTMIG 3.3
MHTERM
NCIt V19.10d
C83118
Modified Reported Term
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): If MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C2826302
SDTMIG 3.3
MHMODIFY
NCIt V19.10d
C83333
Dictionary-Derived Term
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Dictionary-derived text description of MHTERM or MHMODIFY. Equivalent to the Preferred Term (PT in MedDRA). The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the external codelist element in the Define-XML document. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826605
SDTMIG 3.3
MHDECOD
NCIt V19.10d
C83346
Medical History Event Date Type
Description

Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. Examples: "DIAGNOSIS", "SYMPTOMS", "RELAPSE", "INFECTION". Controlled Terms or Format (if applicable): (MHEDTTYP), extensible

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0332307
SDTMIG 3.3
MHEVDTYP
Category for Medical History
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): Used to define a category of related records. Examples: "CARDIAC" or "GENERAL". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0262926
SDTMIG 3.3
MHCAT
NCIt V19.10d
C83018
Subcategory for Medical History
Description

Role: Grouping Qualifier CDISC Notes (for domains) Description (for General Classes): A further categorization of the condition or event. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1515010
SDTMIG 3.3
MHSCAT
NCIt V19.10d
C83143
Medical History Event Pre-Specified
Description

Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): A value of "Y" indicates that this medical history event was pre-specified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms). Controlled Terms or Format (if applicable): (NY), not extensible

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2826245
SDTMIG 3.3
MHPRESP
NCIt V19.10d
C87897
Medical History Occurrence
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used when the occurrence of specific medical history conditions is solicited, to indicate whether or not ("Y"/"N") a medical condition (MHTERM) had ever occurred. Values are null for spontaneously reported events. Controlled Terms or Format (if applicable): (NY), not extensible

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2745955
SDTMIG 3.3
MHOCCUR
NCIt V19.10d
C83067
Completion Status
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): The status indicates that the pre-specified question was not asked/answered. Controlled Terms or Format (if applicable): (ND)

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0805732
UMLS CUI [1,3]
C1522634
SDTMIG 3.3
MHSTAT
NCIt V19.10d
C83337
Reason Medical History Not Collected
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes the reason why data for a pre-specified condition was not collected. Used in conjunction with MHSTAT when value is "NOT DONE". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C2826287
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1516698
SDTMIG 3.3
MHREASND
NCIt V19.10d
C83334
Body System or Organ Class
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Dictionary-derived. Body system or organ class that is involved in an event or measurement from a standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0460002
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0456387
SDTMIG 3.3
MHBODSYS
Planned Order of Element within Arm
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C1705175
UMLS CUI [1,3]
C3812827
UMLS CUI [1,4]
C1522541
SDTMIG 3.3
TAETORD
NCIt V19.10d
C83438
Epoch
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Epoch associated with the start date/time of the medical history event. Controlled Terms or Format (if applicable): (EPOCH), extensible

Data type

text

Alias
UMLS CUI [1]
C2347803
SDTMIG 3.3
EPOCH
NCIt V19.10d
C71738
Date/Time of History Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Collection date and time of the medical history observation represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1516698
SDTMIG 3.3
MHDTC
NCIt V19.10d
C83328
Start Date/Time of Medical History Event
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Start date/time of the medical history event represented in ISO 8601 character format. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1]
C2826928
SDTMIG 3.3
MHSTDTC
NCIt V19.10d
C83338
End Date/Time of Medical History Event
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): End date/time of the medical history event. Controlled Terms or Format (if applicable): ISO 8601

Data type

datetime

Alias
UMLS CUI [1]
C2826920
SDTMIG 3.3
MHENDTC
NCIt V19.10d
C83330
Study Day of History Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Study day of medical history collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. Controlled Terms or Format (if applicable): NA

Data type

integer

Measurement units
  • d
Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C1516698
SDTMIG 3.3
MHDY
NCIt V19.10d
C83329
d
End Relative to Reference Period
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Describes the end of the event relative to the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Controlled Terms or Format (if applicable): (STENRF), not extensible

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1709877
SDTMIG 3.3
MHENRF
NCIt V19.10d
C83331
End Relative to Reference Time Point
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Identifies the end of the event as being before or after the reference time point defined by variable MHENTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Controlled Terms or Format (if applicable): (STENRF), not extensbile

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1709877
UMLS CUI [1,5]
C2348792
SDTMIG 3.3
MHENRTPT
NCIt V19.10d
C87895
End Reference Time Point
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Description or date/time in ISO 8601 character format of the reference point referred to by MHENRTPT. Examples: "2003-12-25" or "VISIT 2". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C1709877
UMLS CUI [1,4]
C2348792
SDTMIG 3.3
MHENTPT
NCIt V19.10d
C87896
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Similar models

Observation Class: Events - Domain: Medical History

59 forms
  1. StudyEvent: ODM
    1. Observation Class: Special Purpose - Domain: Comments
    2. Observation Class: Special Purpose - Domain: Demographics
    3. Observation Class: Special Purpose - Domain: Subject Elements
    4. Observation Class: Special Purpose - Domain: Subject Disease Milestones
    5. Observation Class: Special Purpose - Domain: Subject Visits
    6. Observation Class: Interventions - Domain: Procedure Agents
    7. Observation Class: Interventions - Domain: Concomitant/Prior Medications
    8. Observation Class: Interventions - Domain: Exposure
    9. Observation Class: Interventions - Domain: Exposure as Collected
    10. Observation Class: Interventions - Domain: Meal Data
    11. Observation Class: Interventions - Domain: Procedures
    12. Observation Class: Interventions - Domain: Substance Use
    13. Observation Class: Events - Domain: Adverse Events
    14. Observation Class: Events - Domain: Clinical Events
    15. Observation Class: Events - Domain: Disposition
    16. Observation Class: Events - Domain: Protocol Deviations
    17. Observation Class: Events - Domain: Healthcare Encounters
    18. Observation Class: Events - Domain: Medical History
    19. Observation Class: Findings - Domain: Drug Accountability
    20. Observation Class: Findings - Domain: Death Details
    21. Observation Class: Findings - Domain: ECG Test Results
    22. Observation Class: Findings - Domain: Inclusion/Exclusion Criteria Not Met
    23. Observation Class: Findings - Domain: Immunogenicity Specimen Assessments
    24. Observation Class: Findings - Domain: Laboratory Test Results
    25. Observation Class: Findings - Domain: Microbiology Specimen
    26. Observation Class: Findings - Domain: Microbiology Susceptibility
    27. Observation Class: Findings - Domain: Microscopic Findings
    28. Observation Class: Findings - Domain: Morphology
    29. Observation Class: Findings - Domain: Cardiovascular System Findings
    30. Observation Class: Findings - Domain: Musculoskeletal System Findings
    31. Observation Class: Findings - Domain: Nervous System Findings
    32. Observation Class: Findings - Domain: Ophthalmic Examinations
    33. Observation Class: Findings - Domain: Reproductive System Findings
    34. Observation Class: Findings - Domain: Respiratory System Findings
    35. Observation Class: Findings - Domain: Urinary System Findings
    36. Observation Class: Findings - Domain: Pharmacokinetics Concentrations
    37. Observation Class: Findings - Domain: Pharmacokinetics Parameters
    38. Observation Class: Findings - Domain: Physical Examination
    39. Observation Class: Findings - Domain: Functional Tests
    40. Observation Class: Findings - Domain: Questionnaires
    41. Observation Class: Findings - Domain: Disease Response and Clin Classification
    42. Observation Class: Findings - Domain: Subject Characteristics
    43. Observation Class: Findings - Domain: Subject Status
    44. Observation Class: Findings - Domain: Tumor/Lesion Identification
    45. Observation Class: Findings - Domain: Tumor/Lesion Results
    46. Observation Class: Findings - Domain: Vital Signs
    47. Observation Class: Findings - Domain: Findings About Events or Interventions
    48. Observation Class: Findings - Domain: Skin Response
    49. Observation Class: Trial Design - Domain: Trial Arms
    50. Observation Class: Trial Design - Domain: Trial Elements
    51. Observation Class: Trial Design - Domain: Trial Visits
    52. Observation Class: Trial Design - Domain: Trial Disease Assessments
    53. Observation Class: Trial Design - Domain: Trial Disease Milestones
    54. Observation Class: Trial Design - Domain: Trial Inclusion/Exclusion Criteria
    55. Observation Class: Trial Design - Domain: Trial Summary Information
    56. Observation Class: Relationships - Domain: Related Records
    57. Observation Class: Relationships - Domain: Supplemental Qualifiers for [domain name]
    58. Observation Class: Relationships - Domain: Related Subjects
    59. Observation Class: Study Reference - Domain: Non-host Organism Identifiers
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical History
MH (SDTMIG v3.3)
C0262926 (UMLS CUI-1)
C49603 (NCIt V19.10d:)
STUDYID
Item
Study Identifier
text
C2826693 (UMLS CUI [1])
STUDYID (SDTMIG 3.3)
C83082 (NCIt V19.10d)
DOMAIN
Item
Domain Abbreviation
text
C1883204 (UMLS CUI [1,1])
C0000723 (UMLS CUI [1,2])
DOMAIN (SDTMIG 3.3)
C49556 (NCIt V19.10d)
USUBJID
Item
Unique Subject Identifier
text
C1710548 (UMLS CUI [1,1])
C2826693 (UMLS CUI [1,2])
USUBJID (SDTMIG 3.3)
C70731 (NCIt V19.10d)
SEQ
Item
Sequence Number
integer
C0262926 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
MHSEQ (SDTMIG 3.3)
C83336 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0262926 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
MHGRPID (SDTMIG 3.3)
C83332 (NCIt V19.10d)
REFID
Item
Reference ID
text
C0262926 (UMLS CUI [1,1])
C2826265 (UMLS CUI [1,2])
MHREFID (SDTMIG 3.3)
C83332 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C0262926 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
MHSPID (SDTMIG 3.3)
C83079 (NCIt V19.10d)
TERM
Item
Reported Term for the Medical History
text
C2826302 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
MHTERM (SDTMIG 3.3)
C83118 (NCIt V19.10d)
MODIFY
Item
Modified Reported Term
text
C0262926 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
MHMODIFY (SDTMIG 3.3)
C83333 (NCIt V19.10d)
DECOD
Item
Dictionary-Derived Term
text
C0262926 (UMLS CUI [1,1])
C2826605 (UMLS CUI [1,2])
MHDECOD (SDTMIG 3.3)
C83346 (NCIt V19.10d)
Item
Medical History Event Date Type
text
C0262926 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
MHEVDTYP (SDTMIG 3.3)
EVDTYP
Code List
Medical History Event Date Type
CL Item
Diagnostic (DIAGNOSIS)
C0011900 (UMLS CUI-1)
C15220 (NCIt V19.10d)
CL Item
EPISODE (EPISODE)
C0332189 (UMLS CUI-1)
C75539 (NCIt V19.10d)
CL Item
EXACERBATION (EXACERBATION)
C4086268 (UMLS CUI-1)
C124138 (NCIt V19.10d)
CL Item
SYMPTOM ONSET (SYMPTOM ONSET)
C4086878 (UMLS CUI-1)
C124353 (NCIt V19.10d)
CAT
Item
Category for Medical History
text
C0683312 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
MHCAT (SDTMIG 3.3)
C83018 (NCIt V19.10d)
SCAT
Item
Subcategory for Medical History
text
C0262926 (UMLS CUI [1,1])
C1515010 (UMLS CUI [1,2])
MHSCAT (SDTMIG 3.3)
C83143 (NCIt V19.10d)
Item
Medical History Event Pre-Specified
text
C0262926 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
MHPRESP (SDTMIG 3.3)
C87897 (NCIt V19.10d)
DTHFL
Code List
Medical History Event Pre-Specified
CL Item
No (N)
C1298908 (UMLS CUI-1)
C49487 (NCIt V19.10d)
CL Item
NA; Not Applicable (NA)
C1272460 (UMLS CUI-1)
C48660 (NCIt V19.10d)
CL Item
U; UNK; Unknown (U)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
CL Item
Yes (Y)
C1705108 (UMLS CUI-1)
C49488 (NCIt V19.10d)
Item
Medical History Occurrence
text
C0262926 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
MHOCCUR (SDTMIG 3.3)
C83067 (NCIt V19.10d)
DTHFL
Code List
Medical History Occurrence
CL Item
No (N)
C1298908 (UMLS CUI-1)
C49487 (NCIt V19.10d)
CL Item
NA; Not Applicable (NA)
C1272460 (UMLS CUI-1)
C48660 (NCIt V19.10d)
CL Item
U; UNK; Unknown (U)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
CL Item
Yes (Y)
C1705108 (UMLS CUI-1)
C49488 (NCIt V19.10d)
STAT
Item
Completion Status
text
C0262926 (UMLS CUI [1,1])
C0805732 (UMLS CUI [1,2])
C1522634 (UMLS CUI [1,3])
MHSTAT (SDTMIG 3.3)
C83337 (NCIt V19.10d)
REASND
Item
Reason Medical History Not Collected
text
C2826287 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
MHREASND (SDTMIG 3.3)
C83334 (NCIt V19.10d)
BODSYS
Item
Body System or Organ Class
text
C0262926 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
MHBODSYS (SDTMIG 3.3)
TAETORD
Item
Planned Order of Element within Arm
integer
C1301732 (UMLS CUI [1,1])
C1705175 (UMLS CUI [1,2])
C3812827 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,4])
TAETORD (SDTMIG 3.3)
C83438 (NCIt V19.10d)
Item
Epoch
text
C2347803 (UMLS CUI [1])
EPOCH (SDTMIG 3.3)
C71738 (NCIt V19.10d)
EPOCH
Code List
Epoch
CL Item
BASELINE (BASELINE)
C1552824 (UMLS CUI-1)
C125938 (NCIt V19.10d)
CL Item
BLINDED TREATMENT (BLINDED TREATMENT)
C3640651 (UMLS CUI-1)
C102255 (NCIt V19.10d)
CL Item
Continuation Phase (CONTINUATION TREATMENT)
C4055184 (UMLS CUI-1)
C123452 (NCIt V19.10d)
CL Item
FOLLOW-UP (FOLLOW-UP)
C3274571 (UMLS CUI-1)
C99158 (NCIt V19.10d)
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
C4049995 (UMLS CUI-1)
C123453 (NCIt V19.10d)
CL Item
LONG-TERM FOLLOW-UP (LONG-TERM FOLLOW-UP)
C1517942 (UMLS CUI-1)
C16032 (NCIt V19.10d)
CL Item
OPEN LABEL TREATMENT (OPEN LABEL TREATMENT)
C3640652 (UMLS CUI-1)
C102256 (NCIt V19.10d)
CL Item
RUN-IN (RUN-IN)
C3274438 (UMLS CUI-1)
C98779 (NCIt V19.10d)
CL Item
SCREENING (SCREENING)
C1710477 (UMLS CUI-1)
C48262 (NCIt V19.10d)
CL Item
TREATMENT (TREATMENT)
C3538994 (UMLS CUI-1)
C101526 (NCIt V19.10d)
CL Item
WASHOUT (WASHOUT)
C1710661 (UMLS CUI-1)
C42872 (NCIt V19.10d)
DTC
Item
Date/Time of History Collection
datetime
C1264639 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
MHDTC (SDTMIG 3.3)
C83328 (NCIt V19.10d)
STDTC
Item
Start Date/Time of Medical History Event
datetime
C2826928 (UMLS CUI [1])
MHSTDTC (SDTMIG 3.3)
C83338 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Medical History Event
datetime
C2826920 (UMLS CUI [1])
MHENDTC (SDTMIG 3.3)
C83330 (NCIt V19.10d)
DY
Item
Study Day of History Collection
integer
C2826182 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
MHDY (SDTMIG 3.3)
C83329 (NCIt V19.10d)
Item
End Relative to Reference Period
text
C0262926 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1709877 (UMLS CUI [1,4])
MHENRF (SDTMIG 3.3)
C83331 (NCIt V19.10d)
STRF
Code List
End Relative to Reference Period
CL Item
AFTER (AFTER)
C0687676 (UMLS CUI-1)
C38008 (NCIt V19.10d)
CL Item
BEFORE (BEFORE)
C0332152 (UMLS CUI-1)
C25629 (NCIt V19.10d)
CL Item
COINCIDENT (COINCIDENT)
C0205420 (UMLS CUI-1)
C25456 (NCIt V19.10d)
CL Item
DURING (DURING)
C0347984 (UMLS CUI-1)
C25490 (NCIt V19.10d)
CL Item
DURING/AFTER (DURING/AFTER)
C1707834 (UMLS CUI-1)
C49640 (NCIt V19.10d)
CL Item
Continuous (ONGOING)
C0549178 (UMLS CUI-1)
C53279 (NCIt V19.10d)
CL Item
U; UNK; Unknown (UNKNOWN)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
Item
End Relative to Reference Time Point
text
C0262926 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1709877 (UMLS CUI [1,4])
C2348792 (UMLS CUI [1,5])
MHENRTPT (SDTMIG 3.3)
C87895 (NCIt V19.10d)
STRF
Code List
End Relative to Reference Time Point
CL Item
AFTER (AFTER)
C0687676 (UMLS CUI-1)
C38008 (NCIt V19.10d)
CL Item
BEFORE (BEFORE)
C0332152 (UMLS CUI-1)
C25629 (NCIt V19.10d)
CL Item
COINCIDENT (COINCIDENT)
C0205420 (UMLS CUI-1)
C25456 (NCIt V19.10d)
CL Item
DURING (DURING)
C0347984 (UMLS CUI-1)
C25490 (NCIt V19.10d)
CL Item
DURING/AFTER (DURING/AFTER)
C1707834 (UMLS CUI-1)
C49640 (NCIt V19.10d)
CL Item
Continuous (ONGOING)
C0549178 (UMLS CUI-1)
C53279 (NCIt V19.10d)
CL Item
U; UNK; Unknown (UNKNOWN)
C0439673 (UMLS CUI-1)
C17998 (NCIt V19.10d)
ENTPT
Item
End Reference Time Point
text
C0262926 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C1709877 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,4])
MHENTPT (SDTMIG 3.3)
C87896 (NCIt V19.10d)
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