0 Ratings

ID

32699

Description

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Keywords

  1. 11/13/18 11/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY-NC 3.0

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    Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

    Medical Conditions at Onset of Liver Event

    Liver Disease Medical Conditions
    Description

    Liver Disease Medical Conditions

    Alias
    UMLS CUI-1
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI-2
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Acute Viral Hepatitis A
    Description

    Acute type A viral hepatitis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0276434 (Acute type A viral hepatitis)
    SNOMED
    25102003
    Chronic Hepatitis B
    Description

    Hepatitis B, Chronic

    Data type

    text

    Alias
    UMLS CUI [1]
    C0524909 (Hepatitis B, Chronic)
    SNOMED
    61977001
    Chronic Hepatitis C
    Description

    Hepatitis C, Chronic

    Data type

    text

    Alias
    UMLS CUI [1]
    C0524910 (Hepatitis C, Chronic)
    SNOMED
    128302006
    Cytomegalovirus Hepatitis
    Description

    Cytomegalovirus Hepatitis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0276252 (Cytomegalovirus hepatitis)
    SNOMED
    186698009
    Epstein Barr Virus Infectious Mononucleosis
    Description

    Infectious Mononucleosis, Epstein-Barr Virus

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021345 (Infectious Mononucleosis)
    SNOMED
    271558008
    UMLS CUI [1,2]
    C0014644 (Epstein-Barr virus)
    SNOMED
    40168006
    Herpes Simplex Hepatitis
    Description

    Herpes Simplex Hepatitis

    Data type

    text

    Alias
    UMLS CUI [1]
    C1963747 (Herpes simplex hepatitis)
    SNOMED
    1087101000119109
    Alcoholic Liver Disease
    Description

    Alcoholic Liver Diseases

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023896 (Alcoholic Liver Diseases)
    SNOMED
    41309000
    Non-alcoholic Steatohepatitis
    Description

    Nonalcoholic Steatohepatitis

    Data type

    text

    Alias
    UMLS CUI [1]
    C3241937 (Nonalcoholic Steatohepatitis)
    SNOMED
    442685003
    Fatty Liver
    Description

    Fatty Liver

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015695 (Fatty Liver)
    SNOMED
    197321007
    Hepatic Cirrhosis
    Description

    Liver Cirrhosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023890 (Liver Cirrhosis)
    SNOMED
    19943007
    Hemochromatosis
    Description

    Hemochromatosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018995 (Hemochromatosis)
    SNOMED
    399187006
    Autoimmune Hepatitis
    Description

    Hepatitis, Autoimmune

    Data type

    text

    Alias
    UMLS CUI [1]
    C0241910 (Autoimmune Chronic Hepatitis)
    SNOMED
    197284004
    Gallbladder disease
    Description

    Gall Bladder diseases

    Data type

    text

    Alias
    UMLS CUI [1]
    C0016977 (Gall Bladder Diseases)
    SNOMED
    39621005
    Drug related Liver Disease Conditions
    Description

    Drug related Liver Disease Conditions

    Alias
    UMLS CUI-1
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI-2
    C0277579 (Drug-related disorder)
    SNOMED
    87858002
    Drug related liver disease
    Description

    Liver Disease, Drug-related disorder

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [1,2]
    C0277579 (Drug-related disorder)
    SNOMED
    87858002
    Other Liver Disease Conditions
    Description

    Other Liver Disease Conditions

    Alias
    UMLS CUI-1
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI-2
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Specific Condition
    Description

    Liver diseases

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    Status
    Description

    Liver diseases, Status

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023895 (Liver diseases)
    SNOMED
    235856003
    LOINC
    LA17774-3
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Other Medical Conditions
    Description

    Other Medical Conditions

    Alias
    UMLS CUI-1
    C2359476 (Other diseases or conditions)
    LOINC
    MTHU027558
    Drug Allergies
    Description

    Pharmaceutical Preparations, Hypersensitivity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    Rheumatoid Arthritis
    Description

    Rheumatoid Arthritis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0003873 (Rheumatoid Arthritis)
    SNOMED
    69896004
    LOINC
    LA15161-5
    Psoriasis
    Description

    Psoriasis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0033860 (Psoriasis)
    SNOMED
    9014002
    LOINC
    LA15165-6
    Thyroid Disease
    Description

    Thyroid Diseases

    Data type

    text

    Alias
    UMLS CUI [1]
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    Inflammatory Bowel Disease
    Description

    Inflammatory Bowel Diseases

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390 (Inflammatory Bowel Diseases)
    SNOMED
    24526004
    Lupus
    Description

    Lupus Erythematosus

    Data type

    text

    Alias
    UMLS CUI [1]
    C0409974 (Lupus Erythematosus)
    SNOMED
    200936003
    Sjogren's Syndrome
    Description

    Sjogren's Syndrome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1527336 (Sjogren's Syndrome)
    SNOMED
    83901003
    Vitiligo
    Description

    Vitiligo

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042900 (Vitiligo)
    SNOMED
    56727007
    LOINC
    LA15163-1

    Similar models

    Medical Conditions at Onset of Liver Event

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Liver Disease Medical Conditions
    C0023895 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    Item
    Acute Viral Hepatitis A
    text
    C0276434 (UMLS CUI [1])
    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])
    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])
    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])
    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])
    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])
    Code List
    Herpes Simplex Hepatitis
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)
    Item
    Alcoholic Liver Disease
    text
    C0023896 (UMLS CUI [1])
    Code List
    Alcoholic 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])
    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])
    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])
    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])
    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])
    Code List
    Autoimmune Hepatitis
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)
    Item
    Gallbladder disease
    text
    C0016977 (UMLS CUI [1])
    Code List
    Gallbladder disease
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)
    Item Group
    Drug related Liver Disease Conditions
    C0023895 (UMLS CUI-1)
    C0277579 (UMLS CUI-2)
    Liver Disease, Drug-related disorder
    Item
    Drug related liver disease
    text
    C0023895 (UMLS CUI [1,1])
    C0277579 (UMLS CUI [1,2])
    Item Group
    Other Liver Disease Conditions
    C0023895 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Liver diseases
    Item
    Specific Condition
    text
    C0023895 (UMLS CUI [1])
    Item
    Status
    text
    C0023895 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Code List
    Status
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    Item Group
    Other Medical Conditions
    C2359476 (UMLS CUI-1)
    Item
    Drug Allergies
    text
    C0013227 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    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])
    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])
    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])
    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])
    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])
    Code List
    Lupus
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)
    Item
    Sjogren's Syndrome
    text
    C1527336 (UMLS CUI [1])
    Code List
    Sjogren's Syndrome
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)
    Item
    Vitiligo
    text
    C0042900 (UMLS CUI [1])
    Code List
    Vitiligo
    CL Item
    Current (Current)
    CL Item
    Past (Past)
    CL Item
    No Medical Condition (No Medical Condition)

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