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End of Study/Early Withdrawal - CRFs Paliperidone Palmitate Schizophrenia NCT01515423

- 20.09.21 - 1 Formular, 24 Itemgruppen, 278 Datenelemente, 1 Sprache

Itemgruppen: Date of visit, ECG, Vital signs, Pharmacokinetics, Blood Sample, Paliperidone, Lab Sample Central Lab, Physical Examination, Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, Simpson Angus Rating Scale, Columbia - Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version, Investigator Evaluation of lnjection site, Positive and Negative Syndrome Scale for Schizophrenia, Clinical Global Impression - Severity, Personal and Social Performance Scale, Medication Preference Questionnaire, Involvement Evaluation Questionnaire (Post-Baseline), Resource Use Questionnaire A Hospitalisation, Resource Use Questionnaire B Emergency room visits without hospitalisation, Resource Use Questionnaire C Day clinic, Resource Use Questionnaire D Night clinic, Resource Use Questionnaire E Outpatient treatment, Resource Use Questionnaire F Daily living, Resource Use Questionnaire G Productivity of subject, Evaluation of relapse

A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01515423 Sponsor: Janssen Research & Development, LLC Other drug name: TREVICTA®

End of Study Record - GSK Milveterol COPD 100527

- 19.06.17 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache

Itemgruppe: End of Study Record

Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Logs and Repeats

- 27.09.21 - 1 Formular, 4 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Date of visit/assessment, AE/Concomitant medication/Repeat an assessment check question, Liver event

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Logs and Repeats form.

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 Formular, 5 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: 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

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Treatment Blind, Study conclusion, Pregnancy information

- 24.02.20 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Status of treatment Blind, Study conclusion, Pregnancy information (female), Pregnancy information (male)

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Status of treatment Blind, the Study conclusion and the Pregnancy information form. It has to be filled in for follow-up.

Safety and efficacy of topical Retapamulin Ointment vs. oral Linezolid in Secondarily-Infected Traumatic Lesions and Impetigo due to MRSA, NCT00852540 - Study conclusion, investigational product, status of treatment blind, pregnancy information, Subject product preference

- 15.03.19 - 1 Formular, 6 Itemgruppen, 21 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Study conclusion, Investigational Product, Status of treatment blind, Pregnancy information, Subject medication preference

Study ID: 110978 Clinical Study ID: 110978 Study Title: A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00852540 https://clinicaltrials.gov/ct2/show/NCT00852540 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Retapamulin Ointment, Oral Linezolid Trade Name: N/A Study Indication: Skin Infections, Bacterial The study consists of 5 vists. The studys period extends over 19 days: Visit 1 (Day 1): Baseline (for both, topical and oral visit) Visit 2 (Day 3-4): On-Therapy (for both, topical and oral visit) Visit 3 (Day 7-9): End of Therapy for topical visit, On-Therapy for oral visit. Visit 4 (Day 12-14): Follow-up for topical visit, End of Therapy for oral visit. Visit 5 (Day 17-19): Final Follow-up for topical visit, Follow-up for oral visit. This document contains the Study conclusion, investigational product, status of treatment blind, pregnancy information and Subject product preference form. It has to be filled in for the end of study.

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888 - Status of treatment blind, study conclusion, pregnancy information, investigator's comment and signature

- 31.01.19 - 1 Formular, 6 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Status of treatment blind, Study conclusion, Pregnancy information, Investigator Comment Log, Investigator's signature

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female 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: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the status of treatment blind form, study conclusion, pregnancy information, investigator's comment and signature. It has to be filled in for the end of study.

Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877 - End of study, Investigator Comment Log, Investigator’s Statement

- 23.11.18 - 1 Formular, 4 Itemgruppen, 16 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, End of Study Record, Investigator Comment Log, Investigator’s Statement

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma 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: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the end of study, Investigator Comment Log and Investigator’s Statement form. It has to be filled in at the end of study (after all relevant CRF pages, including outstanding test results, are completed).

Estimation of Dose Proportionality of Darapladib - 107038 - Follow-Up: Study Conclusion

- 13.11.18 - 1 Formular, 1 Itemgruppe, 8 Datenelemente, 1 Sprache

Itemgruppe: Study Conclusion Data

Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

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