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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692 - Pregnancy Information

- 29/11/20 - 1 modulo, 6 itemgroups, 63 elementi, 1 linguaggio
Itemgroups: Administrative , Demography and Medical History (Pregnancy Notification Form), Pregnancy Information (Pregnancy Notification Form) , Demography and Medical History (Pregnancy Outcome Form), Child Information (Pregnancy Outcome Form), Pregnancy Outcome Information (Pregnancy Outcome Form)
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

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Conclusion

- 13/10/20 - 1 modulo, 4 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Date of visit, Assessment Date, Cessation of life, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Measurement Instrument Database for the Social Science (MIDSS) - The Pregnancy Related Beliefs Questionnaire (PRBQ)

- 30/09/20 - 1 modulo, 2 itemgroups, 54 elementi, 1 linguaggio
Itemgroups: Instructions, Belief
Moorhead, S. R. J., Owens, J., Scott, J. (2003). The Pregnancy Related Beliefs Questionnaire (PRBQ). Measurement Instrument Database for the Social Science. Retrieved 29.09.2020, from www.midss.ie Key references: Moorhead, S. R. J., Owens, J., and Scott, J. (2003). DEVELOPMENT AND PILOTING OF THE PREGNANCY RELATED BELIEFS QUESTIONNAIRE (PRBQ). Behavioural and Cognitive Psychotherapy, 31, 207-213. doi:10.1017/S1352465803002091 Primary use / Purpose: The Pregnancy Related Beliefs Questionnaire (PRBQ) is a 54-item inventory rated on 7 point Likert-type scale. Its purpose is to measure women’s' beliefs about pregnancy and make similar contributions as existing scales towards greater understanding and prediction of postnatal depression Background: Psychological measures have proven disappointing in the prediction of postnatal depression in women. To address this weakness, Moorhead, Owens, and Scott (2003) developed the Pregnancy Related Beliefs Questionnaire (PRBQ). The PRBQ was shown to correlate with several other constructs as measured by the Beck Depression Inventory (BDI), the Dysfunctional Attitude Scale, and the Cognitive Adaption to Stressful Events Questionnaire (CASE), as well as showing early potential in the prediction of postnatal depression. Psychometrics: The psychometric properties of the Pregnancy Related Beliefs Questionnaire (PRBQ) are discussed in Moorhead, Owens, and Scott (2003). Digital Object Identifier (DOI): http://dx.doi.org/10.13072/midss.323

Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471) - Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature

- 03/08/20 - 1 modulo, 5 itemgroups, 12 elementi, 1 linguaggio
Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 25/06/20 - 1 modulo, 10 itemgroups, 187 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
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

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Study Conclusion; Pregnancy Information; Investigator Comment Log, Investigator's Signature

- 23/06/20 - 1 modulo, 5 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Administrative, Study Conclusion, Pregnancy Information, Investigator Comment Log, Investigator's Signature
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Urine Pregnancy Test; Serology

- 15/06/20 - 1 modulo, 3 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Administrative, Urine Pregnancy Test (Complete for Female Subjects Only) (Screening, Day-1, Follow-up), Serology
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447 - Pregnancy Notification Form (Subject's Partner)

- 09/06/20 - 1 modulo, 5 itemgroups, 44 elementi, 1 linguaggio
Itemgroups: Administrative, Pregnancy Notification Form - Mother's relevant medical/ family history, Pregnancy Notification Form - Father's relevant medical/ family history , Pregnancy Notification Form - Drug Exposures , Reporting Investigator Information
Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Pregnancy Information Follow-up 7-DF

- 07/06/20 - 1 modulo, 1 ItemGroup, 1 elemento, 1 linguaggio
ItemGroup: Pregnancy Information
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitus Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Follow-up

- 06/06/20 - 1 modulo, 14 itemgroups, 167 elementi, 1 linguaggio
Itemgroups: Date of visit, Vital signs, 12 lead ECG, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Urinalysis, Laboratory Procedures, Hormones, Laboratory Procedures, Free Testosterone Measurement, Laboratory Procedures, Prolactin measurement, Nervous system structure, Evaluation, Ophthalmic examination and evaluation, Blinded Clinical Study, Status, Pregnancy, Information, Conclusion, Clinical Research
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Follow-Up - Pregnancy Information; Study Conclusion; Investigator's Statement; General Comments

- 29/05/20 - 1 modulo, 5 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Administrative, Pregnancy Information, Study Conclusion, Investigator's Statement, General Comments
Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Pregnancy Notification Form (Subject's Partner)

- 26/05/20 - 1 modulo, 6 itemgroups, 45 elementi, 1 linguaggio
Itemgroups: Administrative Data, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Subject withdrawal, Reporting Investigator Information
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 Pregnancy Notification Form is used to report pregnancy to GSK in specific cases specified by the Protocol. This form should be completed according to the protocol reporting requirements. Complete this form for each subject or subject’s partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject’s Case Report Form. Note: This form does not routinely need to be completed for subject’s partner pregnancy unless there is specific instruction to do so stated in the protocol.

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