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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Significant Medical/ Surgical History; Physical Examination; Pregnancy Test

- 20/05/2020 - 1 Formulär, 9 Item-grupper, 28 Dataelement, 1 Språk
Item-grupper: Administrative, Significant Medical/ Surgical History (Period 1 Day -1), Significant Medical/ Surgical History (Period 2 Day -1), Significant Medical/ Surgical History , Physical Examination (Period 1 Day -1), Physical Examination (Period 2 Day -1), Physical Examination (Follow-Up) , Physical Examination - Investigator's Signature, Pregnancy Test (Females only)
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

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 30/10/2019 - 1 Formulär, 19 Item-grupper, 82 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, 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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long Term Follow-Up (Visit 14, Year 10) - General Medical History/ Physical Examination; Laboratory Tests; HCG Urine Pregnancy Test; Vaccine Administration; Solicited Adverse Events - Local Symptoms; Solicited Adverse Events - General Symptoms; Unsolicited Adverse Events

- 21/03/2019 - 1 Formulär, 10 Item-grupper, 87 Dataelement, 1 Språk
Item-grupper: Administration, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501, Monotherapy, Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 10/03/2019 - 1 Formulär, 23 Item-grupper, 109 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment , Disease Marker Assessment , Disease Response, 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 - SRT501 + Bortezomib Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 10/03/2019 - 1 Formulär, 23 Item-grupper, 107 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment , Disease Marker Assessment , Disease Response, 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 - Unscheduled - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment

- 05/03/2019 - 1 Formulär, 19 Item-grupper, 95 Dataelement, 1 Språk
Item-grupper: Administrative, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment, Disease Marker Assessment
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 1 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration

- 03/03/2019 - 1 Formulär, 9 Item-grupper, 36 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Eligibility Summary , Was a physical examination performed?, Physical Examination, Vital Signs, Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, SRT501 Administration
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 2 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 01/03/2019 - 1 Formulär, 23 Item-grupper, 109 Dataelement, 1 Språk
Item-grupper: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment, Disease Marker Assessment , Disease Response, 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 - Screening - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment

- 01/03/2019 - 1 Formulär, 19 Item-grupper, 97 Dataelement, 1 Språk
Item-grupper: Administrative, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment, Disease Marker Assessment
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

GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Follow-Up Physical Examination, Serum b-HCB Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

- 05/08/2017 - 1 Formulär, 4 Item-grupper, 26 Dataelement, 1 Språk
Item-grupper: phaysical examination, serum b-hcg pregnancy test, vital signs, 12-lead ecg monitoring
Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers 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: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation part: Follow-Up Physical Examination, b-HCG Pregnancy Test, Vital Signs, 12-Lead ECG Monitoring

Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Baseline Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/2016 - 1 Formulär, 16 Item-grupper, 104 Dataelement, 1 Språk
Item-grupper: Medical and Surgical History, Significant Medical and Surgical History, NSCLC Diagnosis, NSCLC-related Surgery, Tobacco/Nicotine History at Randomization, Prior Adjuvant Chemotherapy, Prior Adjuvant Chemotherapy for NSCLC, Optional Research Blood Sample, Radiology, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Study Drug Dispensed, Investigator's 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: Baseline Assessments

On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - On-Treatment Assessments, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 27/09/2016 - 1 Formulär, 10 Item-grupper, 40 Dataelement, 1 Språk
Item-grupper: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed
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: On-Treatment Assessments

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