HLA-B*5701 And Hypersensitivity To Abacavir LOGs NCT00373945

1 Formulaires

StudyEvent: ODM
1. HLA-B*5701 And Hypersensitivity To Abacavir LOGs NCT00373945

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Date of Visit/Assessment

Item Group

Date of Visit/Assessment

C1320303 (UMLS CUI-1)

Date of Visit

Item

Date of Visit/Assessment

date

C1320303 (UMLS CUI [1])

Non Serious Adverse Event

Item Group

Non Serious Adverse Event

C1518404 (UMLS CUI-1)

Sequence Number

Item

Sequence Number

text

C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Event

Item

Event Diagnosis only (if known) otherwise Sign/Symptom

text

C0011900 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Modified term

Item

Modified term

text

C2826302 (UMLS CUI [1])
C1518404 (UMLS CUI [2])

MedDRA synonym

Item

MedDRA synonym

text

C0871468 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

MedDRA lower level term code

Item

MedDRA lower level term code

text

C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Failed coding

Item

Failed coding

text

C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])

Start Date

Item

Start Date

date

C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])

Outcome

Item

Outcome

integer

C1705586 (UMLS CUI [1])

Outcome

Code List

Outcome

CL Item

Recovered/Resolved, provide End Date (1)

CL Item

Recovering/Resolving (2)

CL Item

Not recovered/Not resolved (3)

CL Item

Recovered/Resolved with sequelae, provide End Date (4)

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Maximum Toxicity or Intensity

Item

Maximum Toxicity or Intensity

integer

C1710066 (UMLS CUI [1])
C1518404 (UMLS CUI [2])

Maximum Toxicity or Intensity

Code List

Maximum Toxicity or Intensity

CL Item

Mild or Grade 1 (1)

CL Item

Moderate or Grade 2 (2)

CL Item

Severe or Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Not applicable (5)

Action taken with exposure to topical abacavir as a result of the AE

Item

Action taken with exposure to topical abacavir as a result of the AE

integer

C0441472 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])

Action taken with exposure to topical abacavir as a result of the AE

Code List

Action taken with exposure to topical abacavir as a result of the AE

CL Item

Patch removed permanently (1)

CL Item

No action taken (2)

CL Item

Not applicable (3)

Action taken with IP as a Result of the AE

Item

Action taken with IP as a Result of the AE

text

C0441472 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Item

Did the subject withdraw from study as a result of this AE?

text

C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Did the subject withdraw from study as a result of this AE?

CL Item

Yes (Y)

CL Item

No (N)

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

Item

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

text

C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Code List

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

CL Item

Yes (Y)

CL Item

No (N)

Duration of AE if < 24 hours

Item

Duration of AE if < 24 hours

integer

C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Time to Onset Since Last Dose

Item

Time to Onset Since Last Dose

integer

C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Serious Adverse Events

Item Group

Serious Adverse Events

C1519255 (UMLS CUI-1)

Type of report

Item

Type of report

integer

C2348792 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Type of report

Code List

Type of report

CL Item

Initial (1)

CL Item

Follow-Up (2)

Did SAE occur after application of topical abacavir?

Item

Did SAE occur after application of topical abacavir?

text

C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C0185125 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Code List

Did SAE occur after application of topical abacavir?

CL Item

Yes (Y)

CL Item

No (N)

SAE Sequence Number

Item

SAE Sequence Number

text

C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])

Serious Adverse Event

Item

Serious Adverse Event Diagnosis only (if known) otherwise Sign/Symptom

text

C1519255 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])

Modified term

Item

Modified term

text

C2826302 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

MedDRA synonym

Item

MedDRA synonym

text

C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

MedDRA lower level term code

Item

MedDRA lower level term code

text

C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Failed coding

Item

Failed coding

text

C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Outcome

Item

Outcome

integer

C1705586 (UMLS CUI [1])

Outcome

Code List

Outcome

CL Item

Recovered/Resolved, provide End Date (1)

CL Item

Recovering/Resolving (2)

CL Item

Not recovered/Not resolved (3)

CL Item

Recovered/Resolved with sequelae, provide End Date (4)

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Maximum Toxicity or Intensity

Item

Maximum Toxicity or Intensity

integer

C0439793 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Maximum Toxicity or Intensity

Code List

Maximum Toxicity or Intensity

CL Item

Mild or Grade 1 (1)

CL Item

Moderate or Grade 2 (2)

CL Item

Severe or Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Not applicable (5)

Action taken with exposure to topical abacavir as a result of the AE

Item

Action taken with exposure to topical abacavir as a result of the AE

integer

C0441472 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Action taken with exposure to topical abacavir as a result of the AE

Code List

Action taken with exposure to topical abacavir as a result of the AE

CL Item

Patch removed permanently (1)

CL Item

No action taken (2)

CL Item

Not applicable (3)

Action taken with IP as a Result of the AE

Item

Action taken with Investigational Products as a Result of the AE

text

C0441472 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Item

Did the subject withdraw from study as a result of this AE?

text

C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Did the subject withdraw from study as a result of this AE?

CL Item

Yes (Y)

CL Item

No (N)

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

Item

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

text

C1510821 (UMLS CUI [1,1])
C0663655 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])

Did the subject withdraw from study as a result of this AE?

Code List

Is there a reasonable possibility that the AE may have been caused by topical abacavir?

CL Item

Yes (Y)

CL Item

No (N)

Duration of AE if < 24 hours

Item

Duration of AE if < 24 hours

integer

C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Time to Onset Since Last Dose

Item

Time to Onset Since Last Dose

integer

C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])

Was SAE caused by activities related to study participation (e.g. procedures?)

Item

Was SAE caused by activities related to study participation (e.g. procedures?)

text

C1510821 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Was SAE caused by activities related to study participation (e.g. procedures?)

CL Item

Yes (Y)

CL Item

No (N)

Was the event serious?

Item

Was the event serious?

text

C1710056 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Was the event serious?

CL Item

Yes (Y)

CL Item

No (N)

Seriousness

Item

Seriousness

text

C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Seriousness

Code List

Seriousness

CL Item

Results in death (A)

CL Item

Is life-threatening (B)

CL Item

Requires hospitalisation or prolongation of existing hospitalisation (C)

CL Item

Results in disability/incapacity (D)

CL Item

Congenital anomaly/birth defect (E)

CL Item

Other, specify within general narrative comment (F)

CM Sequence Number

Item

CM Sequence Number

text

C2348184 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Drug Name

Item

Drug Name

text

C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Dose

Item

Dose

float

C3174092 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Unit

Item

Unit

text

C1519795 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Unit

Code List

Unit

CL Item

Milligram (MG)

CL Item

Capsule (CAP)

CL Item

Tablet (TAB)

CL Item

Millilitre (ML)

CL Item

Gram (G)

CL Item

Unknown (UNK)

Frequency

Item

Frequency

integer

C3476109 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Frequency

Code List

Frequency

CL Item

2 times per week (1)

CL Item

3 times per week (2)

CL Item

4 times per week (3)

CL Item

5 times per week (4)

CL Item

5 times per day (5)

CL Item

Continuous infusion (6)

CL Item

Every 2 weeks (7)

CL Item

Every 3 weeks (8)

CL Item

Every 3 months (9)

CL Item

Every other day (10)

CL Item

At Bedtime (11)

CL Item

Once a month (12)

CL Item

Once a week (13)

CL Item

Once daily (14)

CL Item

Once only (15)

CL Item

Unknown (16)

Route

Item

Route

integer

C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Route

Code List

Route

CL Item

Both eyes (1)

CL Item

Epidural (2)

CL Item

Gastrostomy tube (3)

CL Item

Inhalation (4)

CL Item

Injection (5)

CL Item

Intra-aterial (6)

CL Item

Intra-bursa (7)

CL Item

Intralesional (8)

CL Item

Intramuscular (9)

CL Item

Intranasal (10)

CL Item

Intraocular (11)

CL Item

Intraosteal (12)

CL Item

Intraperitoneal (13)

CL Item

Intrathecal (14)

CL Item

Intrauterine (15)

CL Item

Intravenous (16)

CL Item

Nasal (17)

CL Item

Oral (18)

CL Item

Rectal (19)

CL Item

Subcutaneous (20)

CL Item

Sublingual (21)

CL Item

Topical (22)

CL Item

Transdermal (23)

CL Item

Vaginal (24)

CL Item

Unknown (25)

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Ongoing?

Item

Ongoing?

text

C0549178 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Code List

Ongoing?

CL Item

Yes (Y)

CL Item

No (N)

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Primary Indication

Item

Primary Indication

text

C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Drug Type

Item

Drug Type

integer

C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])

Drug Type

Code List

Drug Type

CL Item

Concomitant (1)

CL Item

Treatment (2)

CL Item

Cause of SAE (3)

MHx Sequence Number

Item

MHx Sequence Number

text

C2348184 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Specific Condition Name

Item

Specific Condition Name

text

C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Date of Onset

Item

Date of Onset

date

C0808070 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Continuing?

Item

Continuing?

integer

C0549178 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Continuing?

Code List

Continuing?

CL Item

Yes (1)

CL Item

No, specify date of last occurrence (2)

CL Item

Unknown (3)

Date of last occurrence

Item

Date of last occurrence

date

C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

Relevant Medical History / Risk Factors

Item

Relevant Medical History / Risk Factors not noted above

text

C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

Lab Sequence Number

Item

Lab Sequence Number

text

C0262926 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

Test Name

Item

Test Name

text

C0022885 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

Test Date

Item

Test Date

date

C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Test Result

Item

Test Result

text

C0587081 (UMLS CUI [1])
C1519255 (UMLS CUI [2])

Test Units

Item

Test Units

text

C1519795 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

Normal Low Range

Item

Normal Low Range

text

C1514721 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])

High

Item

Normal High Range

text

C1514721 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C0022885 (UMLS CUI [2])

Relevant diagnostic results not notes above

Item

Relevant diagnostic results not notes above

text

C0587081 (UMLS CUI [1,1])
C0086143 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2])

If patch was removed, did the reported event recur after patch was reapplied?

Item

If patch was removed, did the reported event recur after patch was reapplied?

text

C1510821 (UMLS CUI [1,1])
C0030646 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])

If patch was removed, did the reported event recur after patch was reapplied?

Code List

If patch was removed, did the reported event recur after patch was reapplied?

CL Item

Yes (Y)

CL Item

No (N)

CL Item

Unknown (U)

CL Item

Not applicable (X)

General narrative comments

Item

General narrative comments

text

C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

General narrative comments

Item

General narrative comments

text

C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Concomitant Antiretroviral Therapy

Item Group

Concomitant Antiretroviral Therapy

C1963724 (UMLS CUI-1)
C2347852 (UMLS CUI-2)

Sequence Number

Item

Sequence Number

text

C2348184 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Drug Name

Item

Drug Name

text

C2360065 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Modified reported term

Item

Modified reported term

text

C2826302 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

GSK Drug synonym

Item

GSK Drug synonym

text

C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

GSK drug collection code

Item

GSK drug collection code

text

C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Failed coding

Item

Failed coding

text

C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Dose

Item

Dose

integer

C3174092 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Units

Item

Units

text

C1519795 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Unit

Code List

Units

CL Item

Milligram (MG)

CL Item

Capsule (CAP)

CL Item

Tablet (TAB)

CL Item

Millilitre (ML)

CL Item

Gram (G)

CL Item

Unknown (UNK)

Frequency

Item

Frequency

text

C3476109 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Frequency

Code List

Frequency

CL Item

2 times per week (1)

CL Item

3 times per week (2)

CL Item

4 times per week (3)

CL Item

5 times per week (4)

CL Item

5 times per day (5)

CL Item

Continuous infusion (6)

CL Item

Every 2 weeks (7)

CL Item

Every 3 weeks (8)

CL Item

Every 3 months (9)

CL Item

Every other day (10)

CL Item

At Bedtime (11)

CL Item

Once a month (12)

CL Item

Once a week (13)

CL Item

Once daily (14)

CL Item

Once only (15)

CL Item

Unknown (16)

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])

Taken Prior to Study

Item

Taken Prior to Study

text

C2826667 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Taken Prior to Study

CL Item

Yes (Y)

CL Item

No (N)

Ongoing?

Item

Ongoing?

text

C0549178 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])

Did the subject withdraw from study as a result of this AE?

Code List

Ongoing?

CL Item

Yes (Y)

CL Item

No (N)

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])

Medication Type

Item

Medication Type

integer

C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])

Medication Type

Code List

Medication Type

CL Item

Concomitant (1)

CL Item

Treatment (2)

CL Item

Cause of SAE (3)

Concomitant Medications (CONMEDS)

Item Group

Concomitant Medications

C2347852 (UMLS CUI-1)

Sequence Number

Item

Sequence Number

text

C2348184 (UMLS CUI [1])
C2347852 (UMLS CUI [2])

Drug Name

Item

Drug Name

text

C2360065 (UMLS CUI [1])
C2347852 (UMLS CUI [2])

Modified reported term

Item

Modified reported term

text

C2826302 (UMLS CUI [1])
C2347852 (UMLS CUI [2])

GSK Drug synonym

Item

GSK Drug synonym

text

C0013227 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])

GSK drug collection code

Item

GSK drug collection code

text

C0013227 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2])

Failed coding

Item

Failed coding

text

C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])

Reason for Medication

Item

Reason for Medication

text

C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])

Route

Item

Route

integer

C0013153 (UMLS CUI [1])
C2347852 (UMLS CUI [2])

Route

Code List

Route

CL Item

Both eyes (1)

CL Item

Epidural (2)

CL Item

Gastrostomy tube (3)

CL Item

Inhalation (4)

CL Item

Injection (5)

CL Item

Intra-aterial (6)

CL Item

Intra-bursa (7)

CL Item

Intralesional (8)

CL Item

Intramuscular (9)

CL Item

Intranasal (10)

CL Item

Intraocular (11)

CL Item

Intraosteal (12)

CL Item

Intraperitoneal (13)

CL Item

Intrathecal (14)

CL Item

Intrauterine (15)

CL Item

Intravenous (16)

CL Item

Nasal (17)

CL Item

Oral (18)

CL Item

Rectal (19)

CL Item

Subcutaneous (20)

CL Item

Sublingual (21)

CL Item

Topical (22)

CL Item

Transdermal (23)

CL Item

Vaginal (24)

CL Item

Unknown (25)

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Taken Prior to Study

Item

Taken Prior to Study?

text

C2826667 (UMLS CUI [1])
C2347852 (UMLS CUI [2])

Did the subject withdraw from study as a result of this AE?

Code List

Taken Prior to Study?

CL Item

Yes (Y)

CL Item

No (N)

Ongoing?

Item

Ongoing?

text

C0549178 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Did the subject withdraw from study as a result of this AE?

Code List

Ongoing?

CL Item

Yes (Y)

CL Item

No (N)

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])

Medication Type

Item

Medication Type

text

C0013227 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])

Medication Type

Code List

Medication Type

CL Item

Concomitant (1)

CL Item

Treatment (2)

CL Item

Cause of SAE (3)

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