English

Observation Class: Events - Domain: Clinical Events

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
Clinical Events
Description

Clinical Events

Alias
SDTMIG v3.3
CE
UMLS CUI-1
C0205210
UMLS CUI-2
C0441471
NCIt V19.10d:
C85441
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): CE

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 adomain. May be any valid number. Controlled Terms or Format (if applicable): NA

Data type

integer

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2348184
SDTMIG 3.3
CESEQ
NCIt V19.10d
C87854
Group ID
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0441833
UMLS CUI [1,4]
C0600091
SDTMIG 3.3
CEGRPID
NCIt V19.10d
C87850
Reference ID
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Internal or external identifier such as lab specimen ID, or UUID for an ECG waveform or a medical image. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2826265
SDTMIG 3.3
CEREFID
NCIt V19.10d
C87853
Sponsor-Defined Identifier
Description

Role: Identifier CDISC Notes (for domains) Description (for General Classes): Sponsor-defined identifier. Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2347796
UMLS CUI [1,4]
C0600091
SDTMIG 3.3
CESPID
NCIt V19.10d
C87856
Reported Term for the Clinical Event
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0441471
SDTMIG 3.3
CETERM
NCIt V19.10d
C88021
Dictionary-Derived Term
Description

Role: Synonym Qualifier CDISC Notes (for domains) Description (for General Classes): Controlled terminology for the name of the clinical event. 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2826605
SDTMIG 3.3
CEDECOD
NCIt V19.10d
C87846
Category for the Clinical Event
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0683312
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0441471
SDTMIG 3.3
CECAT
NCIt V19.10d
C87844
Subcategory for the Clinical Event
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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1515010
SDTMIG 3.3
CESCAT
NCIt V19.10d
C87861
Clinical Event Pre-specified
Description

Role: Variable Qualifier CDISC Notes (for domains) Description (for General Classes): Used to indicate whether the Event in CETERM was pre-specified. Value is "Y" for pre-specified events and null for spontaneously reported events. Controlled Terms or Format (if applicable): (NY), not extensible

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2826245
SDTMIG 3.3
CEPRESP
NCIt V19.10d
C87852
Clinical Event Occurrence
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Used when the occurrence of specific events is solicited, to indicate whether or not a clinical event 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2745955
SDTMIG 3.3
CEOCCUR
NCIt V19.10d
C87851
Completion Status
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0805732
UMLS CUI [1,4]
C1522634
SDTMIG 3.3
CESTAT
NCIt V19.10d
C113354
Reason Clinical Event Not Collected
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): Describes the reason clinical event data was not collected. Used in conjunction with CESTAT 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]
C0205210
UMLS CUI [1,3]
C0441471
UMLS CUI [1,4]
C1516698
SDTMIG 3.3
CEREASND
NCIt V19.10d
C87842
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 multiaxial 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0460002
UMLS CUI [2,1]
C0205210
UMLS CUI [2,2]
C0441471
UMLS CUI [2,3]
C0178784
UMLS CUI [2,4]
C0456387
SDTMIG 3.3
CEBODSYS
NCIt V19.10d
C87843
Severity/Intensity
Description

Role: Record Qualifier CDISC Notes (for domains) Description (for General Classes): The severity or intensity of the event. Examples: "MILD", "MODERATE", "SEVERE". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0518690
SDTMIG 3.3
CESEV
NCIt V19.10d
C87855
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 clinical event started. 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 clinical 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 Event Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Collection date and time for the clinical event 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]
C0205210
UMLS CUI [1,3]
C0441471
UMLS CUI [1,4]
C1516698
SDTMIG 3.3
CEDTC
NCIt V19.10d
C88013
Start Date/Time of Clinical Event
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0441471
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0441471
SDTMIG 3.3
CESTDTC
NCIt V19.10d
C87857
End Date/Time of Clinical Event
Description

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

Data type

datetime

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0441471
UMLS CUI [2,1]
C1522314
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0441471
SDTMIG 3.3
CEENDTC
NCIt V19.10d
C87841
Study Day of Event Collection
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): 1. Study day of clinical event 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]
C0205210
UMLS CUI [1,3]
C0441471
UMLS CUI [1,4]
C1516698
SDTMIG 3.3
CEDY
NCIt V19.10d
C87845
d
Study Day of Start of Event
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Actual study day of start of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Controlled Terms or Format (if applicable): NA

Data type

integer

Measurement units
  • d
Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0441471
SDTMIG 3.3
CESTDY
NCIt V19.10d
C82570
NCIt V19.10d-2
C85441
d
Study Day of End of Event
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Actual study day of end of the clinical event expressed in integer days relative to the sponsor-defined RFSTDTC in Demographics. Controlled Terms or Format (if applicable): NA

Data type

integer

Measurement units
  • d
Alias
UMLS CUI [1,1]
C2826182
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C0205210
UMLS CUI [1,4]
C0441471
SDTMIG 3.3
CEENDY
NCIt V19.10d
C82569
NCIt V19.10d-2
C85441
d
Start Relative to Reference Period
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Describes the start of the clinical 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C1709877
SDTMIG 3.3
CESTRF
NCIt V19.10d
C87858
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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0444930
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C1709877
SDTMIG 3.3
CEENRF
NCIt V19.10d
C87847
Start Relative to Reference Time Point
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Identifies the start of the observation as being before or after the reference time point defined by variable CESTTPT. 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C1709877
UMLS CUI [1,6]
C2348792
SDTMIG 3.3
CESTRTPT
NCIt V19.10d
C87859
Start 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 sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C1709877
UMLS CUI [1,5]
C2348792
SDTMIG 3.3
CESTTPT
NCIt V19.10d
C87860
End Relative to Reference Time Point
Description

Role: Timing CDISC Notes (for domains) Description (for General Classes): Identifies the end of the observation as being before or after the sponsor-defined reference time point defined by variable CEENTPT. 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]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0444930
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C1709877
UMLS CUI [1,6]
C2348792
SDTMIG 3.3
CEENRTPT
NCIt V19.10d
C87848
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 CEENRTPT. Examples: "2003-12-25" or "VISIT 2". Controlled Terms or Format (if applicable): NA

Data type

text

Alias
UMLS CUI [1,1]
C0205210
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0444930
UMLS CUI [1,4]
C1709877
UMLS CUI [1,5]
C2348792
SDTMIG 3.3
CEENTPT
NCIt V19.10d
C87849
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Similar models

Observation Class: Events - Domain: Clinical Events

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
Clinical Events
CE (SDTMIG v3.3)
C0205210 (UMLS CUI-1)
C0441471 (UMLS CUI-2)
C85441 (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
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
CESEQ (SDTMIG 3.3)
C87854 (NCIt V19.10d)
GRPID
Item
Group ID
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
CEGRPID (SDTMIG 3.3)
C87850 (NCIt V19.10d)
REFID
Item
Reference ID
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2826265 (UMLS CUI [1,3])
CEREFID (SDTMIG 3.3)
C87853 (NCIt V19.10d)
SPID
Item
Sponsor-Defined Identifier
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
CESPID (SDTMIG 3.3)
C87856 (NCIt V19.10d)
TERM
Item
Reported Term for the Clinical Event
text
C2826302 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
CETERM (SDTMIG 3.3)
C88021 (NCIt V19.10d)
DECOD
Item
Dictionary-Derived Term
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2826605 (UMLS CUI [1,3])
CEDECOD (SDTMIG 3.3)
C87846 (NCIt V19.10d)
CAT
Item
Category for the Clinical Event
text
C0683312 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
CECAT (SDTMIG 3.3)
C87844 (NCIt V19.10d)
SCAT
Item
Subcategory for the Clinical Event
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1515010 (UMLS CUI [1,3])
CESCAT (SDTMIG 3.3)
C87861 (NCIt V19.10d)
Item
Clinical Event Pre-specified
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2826245 (UMLS CUI [1,3])
CEPRESP (SDTMIG 3.3)
C87852 (NCIt V19.10d)
DTHFL
Code List
Clinical Event Pre-specified
CL Item
No (N)
CL Item
NA; Not Applicable (NA)
CL Item
U; UNK; Unknown (U)
CL Item
Yes (Y)
Item
Clinical Event Occurrence
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
CEOCCUR (SDTMIG 3.3)
C87851 (NCIt V19.10d)
DTHFL
Code List
Clinical Event Occurrence
CL Item
No (N)
CL Item
NA; Not Applicable (NA)
CL Item
U; UNK; Unknown (U)
CL Item
Yes (Y)
STAT
Item
Completion Status
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0805732 (UMLS CUI [1,3])
C1522634 (UMLS CUI [1,4])
CESTAT (SDTMIG 3.3)
C113354 (NCIt V19.10d)
REASND
Item
Reason Clinical Event Not Collected
text
C2826287 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
CEREASND (SDTMIG 3.3)
C87842 (NCIt V19.10d)
BODSYS
Item
Body System or Organ Class
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0460002 (UMLS CUI [1,3])
C0205210 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
C0178784 (UMLS CUI [2,3])
C0456387 (UMLS CUI [2,4])
CEBODSYS (SDTMIG 3.3)
C87843 (NCIt V19.10d)
SEV
Item
Severity/Intensity
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
CESEV (SDTMIG 3.3)
C87855 (NCIt V19.10d)
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 )
CL Item
BLINDED TREATMENT  (BLINDED TREATMENT )
CL Item
Continuation Phase (CONTINUATION TREATMENT)
CL Item
FOLLOW-UP  (FOLLOW-UP )
CL Item
Induction Phase; Intensive Phase (INDUCTION TREATMENT)
CL Item
LONG-TERM FOLLOW-UP  (LONG-TERM FOLLOW-UP )
CL Item
OPEN LABEL TREATMENT  (OPEN LABEL TREATMENT )
CL Item
RUN-IN  (RUN-IN )
CL Item
SCREENING  (SCREENING )
CL Item
TREATMENT  (TREATMENT )
CL Item
WASHOUT  (WASHOUT )
DTC
Item
Date/Time of Event Collection
datetime
C1264639 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
CEDTC (SDTMIG 3.3)
C88013 (NCIt V19.10d)
STDTC
Item
Start Date/Time of Clinical Event
datetime
C0808070 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C1301880 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0441471 (UMLS CUI [2,3])
CESTDTC (SDTMIG 3.3)
C87857 (NCIt V19.10d)
ENDTC
Item
End Date/Time of Clinical Event
datetime
C0806020 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C1522314 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0441471 (UMLS CUI [2,3])
CEENDTC (SDTMIG 3.3)
C87841 (NCIt V19.10d)
DY
Item
Study Day of Event Collection
integer
C2826182 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,4])
CEDY (SDTMIG 3.3)
C87845 (NCIt V19.10d)
STDY
Item
Study Day of Start of Event
integer
C2826182 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,4])
CESTDY (SDTMIG 3.3)
C82570 (NCIt V19.10d)
C85441 (NCIt V19.10d-2)
ENDY
Item
Study Day of End of Event
integer
C2826182 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,4])
CEENDY (SDTMIG 3.3)
C82569 (NCIt V19.10d)
C85441 (NCIt V19.10d-2)
Item
Start Relative to Reference Period
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C1709877 (UMLS CUI [1,5])
CESTRF (SDTMIG 3.3)
C87858 (NCIt V19.10d)
STRF
Code List
Start Relative to Reference Period
CL Item
AFTER  (AFTER )
CL Item
BEFORE  (BEFORE )
CL Item
COINCItDENT  (COINCItDENT )
CL Item
DURING  (DURING )
CL Item
DURING/AFTER  (DURING/AFTER )
CL Item
Continuous (ONGOING)
CL Item
U; UNK; Unknown (UNKNOWN)
Item
End Relative to Reference Period
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C1709877 (UMLS CUI [1,5])
CEENRF (SDTMIG 3.3)
C87847 (NCIt V19.10d)
STRF
Code List
End Relative to Reference Period
CL Item
AFTER  (AFTER )
CL Item
BEFORE  (BEFORE )
CL Item
COINCItDENT  (COINCItDENT )
CL Item
DURING  (DURING )
CL Item
DURING/AFTER  (DURING/AFTER )
CL Item
Continuous (ONGOING)
CL Item
U; UNK; Unknown (UNKNOWN)
Item
Start Relative to Reference Time Point
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C1709877 (UMLS CUI [1,5])
C2348792 (UMLS CUI [1,6])
CESTRTPT (SDTMIG 3.3)
C87859 (NCIt V19.10d)
STRF
Code List
Start Relative to Reference Time Point
CL Item
AFTER  (AFTER )
CL Item
BEFORE  (BEFORE )
CL Item
COINCItDENT  (COINCItDENT )
CL Item
DURING  (DURING )
CL Item
DURING/AFTER  (DURING/AFTER )
CL Item
Continuous (ONGOING)
CL Item
U; UNK; Unknown (UNKNOWN)
STTPT
Item
Start Reference Time Point
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C1709877 (UMLS CUI [1,4])
C2348792 (UMLS CUI [1,5])
CESTTPT (SDTMIG 3.3)
C87860 (NCIt V19.10d)
Item
End Relative to Reference Time Point
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C1709877 (UMLS CUI [1,5])
C2348792 (UMLS CUI [1,6])
CEENRTPT (SDTMIG 3.3)
C87848 (NCIt V19.10d)
STRF
Code List
End Relative to Reference Time Point
CL Item
AFTER  (AFTER )
CL Item
BEFORE  (BEFORE )
CL Item
COINCItDENT  (COINCItDENT )
CL Item
DURING  (DURING )
CL Item
DURING/AFTER  (DURING/AFTER )
CL Item
Continuous (ONGOING)
CL Item
U; UNK; Unknown (UNKNOWN)
ENTPT
Item
End Reference Time Point
text
C0205210 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C1709877 (UMLS CUI [1,4])
C2348792 (UMLS CUI [1,5])
CEENTPT (SDTMIG 3.3)
C87849 (NCIt V19.10d)
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