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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - PK Blood Sample

- 11/26/21 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data,Dosing date and time,PK Blood Sample
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. Depending on which items, this form has to be filled out at the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits, Cycle 1 and 2 observation visits and unscheduled visits.

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 9/20/21 - 1 form, 8 itemgroups, 58 items, 1 language
Itemgroups: Local Laboratory,Urinalysis | Local,Vital signs,12 lead ECG,Electrocardiogram abnormal,Drug Kinetics; Blood,12 lead ECG | Holter Electrocardiography | Summary Report,Holter Electrocardiography | Electrocardiogram abnormal | Summary Report
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. - Administration, demographics, inclusion criteria, exclusion criteria, infusion details, ecg, alcohol/drug screening, baseline/advers events

- 9/20/21 - 1 form, 14 itemgroups, 86 items, 1 language
Itemgroups: Administration,Demographic Details,Volunteer Inclusion Criteria,Volunteer Exclusion Criteria,Infusion Details,ECG-Arrhythmia,Electrocardiography,Electrocardiography,Alcohol Screening (Blow test),Drug Screening (Urine),Baseline Events,Baseline Events,Adverse Events,Adverse Events
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. - Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

- 9/20/21 - 1 form, 13 itemgroups, 56 items, 1 language
Itemgroups: Administration,Glucose Assay,Glucose Assay,Plasma Drug Assay,Plasma Drug Assay,Volunteer Completion/Withdrawal,Investigator's checklist,Investigator's Statement,Concominant Medication,Missing Data,Missing Data,Missing Data,Missing Data
https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989 - Eligibility Criteria

- 9/20/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: Administrative Data,Eligibility question,Inclusion Criteria,Exclusion Criteria
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the eligibility criteria. It has to be filled in at Day 1.

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - PK Dosing Date Time

- 9/20/21 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: PK Dosing
https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 9/20/21 - 1 form, 18 itemgroups, 90 items, 1 language
Itemgroups: Note,Inclusion Criteria,Exclusion Criteria,Physical examination,Pregnancy test,Alcohol test,Urine drug screening,orthostatic blood pressure / Pulse - Predose,Concomitant medication,Adverse event,Patient diary,Randomization,High fat breakfast,Study Drug Dosing,Orthostatic blood pressure / pulse measurement - post dose,Adverse Event - post dosing,Pharmacokinetic sampling post dosing,Discharge
PART B - Period 1 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Day 1 - Summary Holter; Summary Holter Abnormalities; Electronically Transferred Lab Data; Pharmacokinetics Blood; Urinalysis

- 9/20/21 - 1 form, 24 itemgroups, 323 items, 1 language
Itemgroups: Date of Visit,Summary Holter,Summary Holter Abnormalities,Electroniclly Transferred Lab Data - Dosing Date and Time,Electronically Transerred Lab Data - Pre-dose,Electronically Transerred Lab Data - 1 Hour,Electronically Transerred Lab Data - 2 Hour ,Electronically Transerred Lab Data - 4 Hour,Electronically Transerred Lab Data - 8 Hour ,Electronically Transerred Lab Data - 24 Hour,Electronically Transerred Lab Data - 36 Hour ,Electronically Transerred Lab Data - 48 Hour,Electronically Transerred Lab Data - 72 Hour ,Pharmacokinetics Blood,Pharmacokinetics Blood - Extra Scheduled Samples Entry ,Urinalysis - Dosing Date and Time ,Urinalysis Dipstick Details - Pre-Dose,Urinalysis Dipstick Details - 2 Hour Post-Dose,Urinalysis Dipstick Details - 4 Hour Post-Dose ,Urinalysis Dipstick Details - 8 Hour Post-Dose ,Urinalysis Dipstick Details - 24 Hour Post-Dose ,Urinalysis Dipstick Details -36 Hour Post-Dose,Urinalysis Dipstick Details -48 Hour Post-Dose ,Urinalysis - Local: Microscopy Details
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

Pharmacokinetics

- 9/20/21 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Pharmacokinetics
Record detailed information about the collection of biological samples for analysis of the presence and quantity of the study agent and/or its metabolites. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD257392-F827-EFBD-E040-BB89AD434E1E

Eligibility Acute Heart Failure DRKS00008447 NCT02151383 - Eligibility Acute Heart Failure NCT02151383

- 9/17/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria,Exclusion Criteria
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT02151383

Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629 - Logs and Repeats

- 9/17/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Administrative Data,Adverse Event | Concomitant Medication | Evaluation
This form documents if any measurements were repeated during the study, if concomitant medications were taken or if any adverse events or ECG abnormalities occurred. To be assessed at study conclusion. 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 - ECG Abnormalities

- 9/17/21 - 1 form, 8 itemgroups, 93 items, 1 language
Itemgroups: Administrative Data,12-Lead ECG Abnormalities,Rhythm,P-Wave Morphology,Conduction,Myocardial Infarction,Depolarisation/Repolarisation (QRS-T),ECG, Other abnormalities
This form documents the recorded abnormalities on ECG. To be filled in continously. 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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