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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver imaging

- 2021-11-26 - 1 Formulär, 11 Item-grupper, 61 Dataelement, 1 Språk

Item-grupper: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).

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

- 2021-11-17 - 1 Formulär, 5 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Liver Dysfunction or Failure by Clinical Classification Adverse Event, Serious Adverse Event, Liver Dysfunction or Failure by Clinical Classification Adverse Event, Notifications, Liver function, Laboratory procedures, Medical History, Experimental Drug, Liver

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

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Liver Biopsy

- 2021-09-20 - 1 Formulär, 15 Item-grupper, 161 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of liver biopsy, Liver biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Hepatocytes, Hepatocyte Inclusions or Vacuoles, Hepatocyte Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Parasites or ova in liver biopsy, Histologic Staining of Liver Biopsy or Additional Studies Obtained

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form is to be filled in if a liver biopsy is performed because of an Adverse Liver Event. There are seperate forms for general information on the liver event and for liver imaging (if performed).

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver Events

- 2021-08-30 - 1 Formulär, 10 Item-grupper, 57 Dataelement, 1 Språk

Item-grupper: Administrative Data, Liver chemistry result, Liver events, Liver Pharmacokinetics, Liver investigational product, Liver disease medical conditions, Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver events occur.

Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812 - Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging

- 2021-05-26 - 1 Formulär, 10 Item-grupper, 76 Dataelement, 1 Språk

Item-grupper: Administrative, Liver Events Assessment, Liver Biopsy, Liver Events, Alcohol Intake, Liver Disease Medical Conditions, Drug Related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver Events Assessment

- 2021-02-19 - 1 Formulär, 4 Item-grupper, 10 Dataelement, 1 Språk

Item-grupper: Administrative Data, Liver Events Assessment, Liver IP Rechallenge Status, Liver Events Assessment 2

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. All of these Itemgroups have to be filled out at the second, third and forth weekly visits during treatment cycles. The liver events assessment Itemgroup should also be filled out at the first weekly visit during treatment cycles, as well as the cycle observation visits. The liver events assessment 2 Itemgroup should additionally be filled out at the cycle observation visits as well.

Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673 - Liver Event

- 2020-12-15 - 1 Formulär, 11 Item-grupper, 101 Dataelement, 1 Språk

Item-grupper: Administrative, Liver event assessment, Investigational Product (Liver), Pharmacokinetics (Liver), Medical conditions, Drug related disease conditions, Other liver disease conditions, Other Medical Conditions, Alcohol intake at onset of liver event, Liver Imaging, Liver Biopsy

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries

- 2020-11-29 - 1 Formulär, 10 Item-grupper, 80 Dataelement, 1 Språk

Item-grupper: Administrative, Liver Biopsy, Liver Events Assessment, Liver Events, Liver Disease Medical Conditions, Drug related Liver Disease Conditions, Other Liver Disease Conditions, Other Medical Conditions, Liver Imaging, Liver event follow-up chemistries

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Liver Events

- 2020-08-05 - 1 Formulär, 11 Item-grupper, 100 Dataelement, 1 Språk

Item-grupper: Date of visit, Liver, Adverse event, Evaluation, Liver, Adverse Event, Liver, Adverse Event, Experimental drug, Liver, Adverse event, Pharmacokinetic aspects, Liver, Adverse Event, Disease, Liver, Adverse Event, Drug-related disorder, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

- 2020-06-17 - 1 Formulär, 11 Item-grupper, 60 Dataelement, 1 Språk

Item-grupper: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver imaging - Repeating form (Unscheduled/Dynamic visit)

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Liver Imaging

- 2020-06-17 - 1 Formulär, 12 Item-grupper, 62 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities

This form documents the liver imaging. 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

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Liver biopsy

- 2020-06-16 - 1 Formulär, 15 Item-grupper, 158 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of liver biopsy, Liver Biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Liver: Parasites or Ova, Histologic Staining or Additional Studies Obtained

This form documents the liver biopsy. 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

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