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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - 12-Lead ECG Abnormalities

- 07.06.20 - 1 Formular, 8 Itemgruppen, 91 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, 12-Lead ECG Abnormalities, Rhythm, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study.

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study Period

- 11.12.18 - 1 Formular, 17 Itemgruppen, 85 Datenelemente, 1 Sprache

Itemgruppen: Drug Screen, Ethanol Measurement, Physical Examination, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis, Pharmacokinetic aspects, Blood, Vital signs, 12-Lead-ECG, 12 lead ECG, Abnormality, Randomization, Numbers, Experimental drug, Therapeutic procedure, Confirmation, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Metabolite, Pharmacokinetic aspects, Urine, Pharmacokinetic aspects, Faeces, Entero string test

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG Abnormalities

- 17.12.20 - 1 Formular, 8 Itemgruppen, 90 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, 12-Lead ECG Abnormalities, 12-Lead ECG Rhythm, 12-Lead ECG, P-Wave Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), ECG, Other abnormalities

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia The 12-Lead ECG Abnormalities Form has to be filled in whenever an abnormal ECG curve is recorded durig the study. ECG curves are recorded during the Screening, P1 D1, P2 D1, Follow-Up and Repeat Visits.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - 12-Lead ECG

- 12.12.20 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Dosing date and time, 12-Lead ECG

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening Visit, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.

medical examination SHIP-Trend-1 ECG findings

- 09.01.21 - 1 Formular, 1 Itemgruppe, 72 Datenelemente, 2 Sprachen

Itemgruppe: ECG findings

ECG findings form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MEX.PHYSEXAM.ECGPROCE. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

medical examination SHIP-Trend-1 ECG

- 07.01.21 - 1 Formular, 1 Itemgruppe, 21 Datenelemente, 3 Sprachen

Itemgruppe: ECG

ECG form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.MEX.PHYSEXAM.ECGRECOR. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English and Portuguese version of this form are under development.

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 27.09.21 - 1 Formular, 8 Itemgruppen, 98 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.