ID

33056

Beschreibung

This form contains a form to document the medical conditions and alcohol intake. To be assessed at liver event visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders

Link

https://clinicaltrials.gov/ct2/show/NCT00875784

Stichworte

Versionen (1)
  1. 25.11.18 25.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. November 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX NCT00875784

Englisch

Liver Event: Medical Conditions and Alcohol Intake

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Liver Disease Medical Conditions
Beschreibung

Liver Disease Medical Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
UMLS CUI-4
C0023895
UMLS CUI-5
C0009488
Acute Viral Hepatitis A
Beschreibung

Acute Viral Hepatitis A

Datentyp

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Beschreibung

Chronic Hepatitis B

Datentyp

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Beschreibung

Chronic Hepatitis C

Datentyp

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Beschreibung

Cytomegalovirus Hepatitis

Datentyp

text

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Beschreibung

Epstein Barr Virus Infectious Mononucleosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Beschreibung

Herpes Simplex Hepatitis

Datentyp

text

Alias
UMLS CUI [1]
C1963747
Alcohol Liver Disease
Beschreibung

Alcohol Liver Disease

Datentyp

text

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatitis
Beschreibung

Non-alcoholic Steatohepatitis

Datentyp

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Beschreibung

Fatty Liver

Datentyp

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Beschreibung

Hepatic Cirrhosis

Datentyp

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Beschreibung

Hemochromatosis

Datentyp

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Beschreibung

Autoimmune Hepatitis

Datentyp

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease or biliary disease
Beschreibung

Gallbladder disease or biliary disease

Datentyp

text

Alias
UMLS CUI [1]
C0016977
UMLS CUI [2]
C3275124
Drug Related Liver Disease Conditions (All Drugs including Investigational Product)
Beschreibung

Drug Related Liver Disease Conditions (All Drugs including Investigational Product)

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug related liver disease
Beschreibung

Drug related liver disease

Datentyp

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other Liver Disease Conditions
Beschreibung

Other Liver Disease Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Specific Condition
Beschreibung

Other liver disease, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Status
Beschreibung

Other liver disease status

Datentyp

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other Medical Conditions
Beschreibung

Other Medical Conditions

Alias
UMLS CUI-1
C3843040
Drug Allergies
Beschreibung

Drug Allergies

Datentyp

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Beschreibung

Rheumatoid Arthritis

Datentyp

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Beschreibung

Psoriasis

Datentyp

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Beschreibung

Thyroid Disease

Datentyp

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Beschreibung

Inflammatory Bowel Disease

Datentyp

text

Alias
UMLS CUI [1]
C0021390
Lupus
Beschreibung

Lupus

Datentyp

text

Alias
UMLS CUI [1]
C0409974
Sjogren's Syndrom
Beschreibung

Sjogren's Syndrom

Datentyp

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Beschreibung

Vitiligo

Datentyp

text

Alias
UMLS CUI [1]
C0042900
Alcohol Intake
Beschreibung

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschreibung

If yes, record the average number of units of alcohol consumed per week in the next item

Datentyp

text

Alias
UMLS CUI [1]
C0001948
If the subject consumes alcohol, record the average number of units of alcohol consumed per week
Beschreibung

If yes, record the average number of units of alcohol consumed per week in the next item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
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Ähnliche Modelle

Liver Event: Medical Conditions and Alcohol Intake

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0023895 (UMLS CUI-4)
C0009488 (UMLS CUI-5)
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Acute Viral Hepatitis A
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
Chronic Hepatitis B
Code List
Chronic Hepatitis B
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Chronic Hepatitis C
Code List
Chronic Hepatitis C
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
Cytomegalovirus Hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Epstein Barr Virus Infectious Mononucleosis
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
Herpes Simplex Hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Alcohol Liver Disease
text
C0023896 (UMLS CUI [1])
Alcohol Liver Disease
Code List
Alcohol Liver Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Non-alcoholic Steatohepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
Fatty Liver
Code List
Fatty Liver
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Hepatic Cirrhosis
Code List
Hepatic Cirrhosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Hemochromatosis
Code List
Hemochromatosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Autoimmune Hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Conditions (No Medical Conditions)
Item
Gallbladder disease or biliary disease
text
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
Gallbladder disease or biliary disease
Code List
Gallbladder disease or biliary disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Drug Related Liver Disease Conditions (All Drugs including Investigational Product)
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug related liver disease
Code List
Drug related liver disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Other Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other liver disease, specification
Item
Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Status
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Other liver disease status
Code List
Status
CL Item
Current (Current)
CL Item
Past (Past)
Item Group
Other Medical Conditions
C3843040 (UMLS CUI-1)
Item
Drug Allergies
text
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Allergies
Code List
Drug Allergies
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis
Code List
Rheumatoid Arthritis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
Psoriasis
Code List
Psoriasis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
Thyroid Disease
Code List
Thyroid Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
Inflammatory Bowel Disease
Code List
Inflammatory Bowel Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Lupus
text
C0409974 (UMLS CUI [1])
Lupus
Code List
Lupus
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Sjogren's Syndrom
text
C1527336 (UMLS CUI [1])
Sjogren's Syndrom
Code List
Sjogren's Syndrom
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
Vitiligo
Code List
Vitiligo
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Alcohol consumption
Code List
Does the subject consume alcohol?
CL Item
No (No)
CL Item
Yes (Yes)
Average number of units of alcohol consumption per week
Item
If the subject consumes alcohol, record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
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