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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046 - Protocol Deviation

- 11/12/19 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Administrative documentation, Protocol Deviations
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains information on protocol deviations, and is filled in by the Sponsor's (GSK) monitoring staff only.

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Non Visit - Adverse Events; Prior and Concomitant Medications; Comments; Protocol Deviations; Data Verification

- 10/30/19 - 1 form, 10 itemgroups, 36 items, 1 language
Itemgroups: Administrative, Adverse Events, Adverse Events, Prior and Concomitant Medications, Prior and Concomitant Medications , Are any comments required? , Comments, Did the subject deviate from the procedures as described in the protocol?, Protocol Deviations, Data Verification
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Efficacy and Tolerability of TREXIMA Tablets vs. Placebo During Mild Migraine Study ID 101998 - Investigational Product Use/Status of Treatment Blind

- 1/25/19 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data, Investigational Product Use, Status Of Treatment Blind
Study ID: 101998 Clinical Study ID: 101998 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine Patient Level Data Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor GlaxoSmithKline Collaborators N/A Phase Phase 3 Study Recruitment Status Completed Generic Name sumatriptan Trade Name Imitrex ,Imiject ,Imigran Study Indication Migraine Disorders The purpose of this form is to document the subjects intake of the investigational product and the status of treatment blind. It should be filled out at the final visit.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Study conclusion

- 12/6/18 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Study conclusion details, If YES, complete primary reason for withdrawal
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Run-In Failure Report

- 12/6/18 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Run-In Failure
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

CDASH Protocol Deviations - Protocol Deviations

- 6/20/18 - 1 form, 2 itemgroups, 4 items, 2 languages
Itemgroups: General information, Details
modified from http://www.cdisc.org

NCI Standard Protocol Deviations Template

- 7/14/17 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: Protocol Deviations
The collection of CDEs used in the protocol deviations module. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4DA99369-4E65-7200-E044-0003BA3F9857

Deviation Log, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Deviation Log, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 8/1/16 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Deviation Log, Signature
Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part of Study: Deviation Log

Protocol Deviations Multiple Sclerosis ALAIN01 NCT02419378

- 5/28/16 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Protocol Deviations, Protocol Deviations RQG
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Sarcoma, Kaposi xxx Comments - Comments Form - RF34 - 2266179v3.0 - Comments Form - RF34

- 1/9/15 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: CCRR MODULE
Comments Form - RF34 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE1CE9F-A5EF-42E0-E034-0003BA12F5E7

Ewing Study Protokollabweichungen DRKS00003588 - Protokollabweichungen

- 8/4/14 - 1 form, 2 itemgroups, 7 items, 2 languages
Itemgroups: Show identification of patient, Protokollabweichungen
EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

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