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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 2 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 30.10.19 - 1 Formular, 6 Itemgruppen, 16 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Visit Date, PK Sampling - Plasma Samples, SRT501 Administration, Study Treatment Compliance (Return), New Adverse Events and Concomitant Treatment
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

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 20 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 30.10.19 - 1 Formular, 6 Itemgruppen, 20 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Visit Date, PK Sampling - Plasma Samples, SRT501 Administration, Study Treatment Compliance (Return), New Adverse Events and Concomitant Treatment
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

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

- 30.10.19 - 1 Formular, 10 Itemgruppen, 36 Datenelemente, 1 Sprache
Itemgruppen: 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

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

- 30.10.19 - 1 Formular, 13 Itemgruppen, 73 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Temperature Log, Reminder, Rash / Exanthem, Rash Event Log, Parotid/Salivary Gland Swelling Events, Febrile Convulsions - Suspected Signs of Meningitis, Concomitant Vaccination, Concomitant Vaccination Details, Concomitant Medications, Concomitant Medications Details, Non-Serious Adverse Events, Non-Serious Adverse Events Log
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Concomitant medication_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79 - Documentation concomitant medication

- 30.10.19 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Concomitant medication
Study part: Documentation concomitant medication. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Adverse Events & Concomitant Medications Week 3 (Visit 7) Ropinirole Parkinson Disease 101468/165 - Adverse Events & Concomitant Medications Week 3 (Visit 7)

- 30.10.19 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache
Itemgruppe: Adverse Events; Concomitant Medications
Study Part: Adverse Events & Concomitant Medications Week 3 (Visit 7). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Concomitant Medications Form

- 30.10.19 - 1 Formular, 1 Itemgruppe, 22 Datenelemente, 1 Sprache
Itemgruppe: Concomitant Medication Details
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

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Concomitant Medication Form

- 30.10.19 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Concomitant Medications
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Diary Card 3: Concomitant Medications

- 30.10.19 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Medication, Reminder
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080 - Investigational Product; Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medication; Non-Serious Adverse Events; Serious Adverse Events

- 30.10.19 - 1 Formular, 24 Itemgruppen, 92 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Investigational Product, Status of Treatment Blind, Consent for Pharmacogenetic Research, PGx - Blood Sample Collection (DNA), PGx - Withdrawal of Consent, PGx - Blood Sample Destruction, Concomitant Medications, Concomitant Medications , Non-Serious Adverse Events, Non-Serious Adverse Events , Serious Adverse Events, Serious Adverse Events - Section 1, Serious Adverse Events - Section 2 (Seriousness), Serious Adverse Events - Section 3 (Demography Data), Serious Adverse Events - Section 4, Serious Adverse Events - Section 5 (Possible Cause of SAE), Serious Adverse Events - Medical Conditions, Serious Adverse Events - Section 7 (Other relevant Risk Factors), Serious Adverse Events - Section 8 (Relevant Concomitant Medication), Serious Adverse Events - Section 9 (Details of Investigational Product(s)), Serious Adverse Events - Section 10 ( Details of relevant Assessments), Serious Adverse Events - Section 11 (Narrative Remarks), Serious Adverse Events - Investigator's signature
Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 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

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications

- 30.10.19 - 1 Formular, 15 Itemgruppen, 105 Datenelemente, 1 Sprache
Itemgruppen: Non-Serious Adverse Event, Serious Adverse Event, SAE - Type of Report, SAE- Randomisation, SAE - Seriousness, SAE - Relevant Concomitant Medications, SAE - Relevant Medical Conditions/ Risk Factors, SAE - Relevant Diagnostic Results, SAE - Rechallenge, SAE - Investigational Product, SAE - Investigational Product, SAE - Investigational Product , SAE - General Narrative Comments, SAE - Non clinical, Concomitant Medications
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933 - Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs

- 28.10.19 - 1 Formular, 15 Itemgruppen, 122 Datenelemente, 1 Sprache
Itemgruppen: Logs and Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Liver event, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Electronically Transferred Steroid Hormone Lab Data, Vital signs
Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

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