Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Study Conclusion, Pregnancy Information and Investigator Comment Log

- 27-09-21 - 1 Formulier, 5 Itemgroepen, 14 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's Signature

This ODM file contains the form to document pregnancy information at the end of the study, the study conclusion and also includes an investigator's comment log. Study ID: 101999 Clinical Study ID: 101999 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

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - Screening

- 27-09-21 - 1 Formulier, 18 Itemgroepen, 51 Data-elementen, 1 Taal

Itemgroepen: Date of Visit/Assessment, Subject Identification, Demography, Demography - Geographic Ancestry, Demography_Contraceptive Methods, Eligibility Question, Inclusion/Exclusion Criteria, Screen Failure, investigator signature, Previous Clinical Trial Participation, Vital Signs, PGx-Pharmacogenetic Research Consent, Medical conditions, IHS Headache Classification, Migraine history, Previous treatment for migraine, Other previous treatment for migraine, Treatment satisfaction

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Zytoreduktive Chirurgie / HIPEC Part 1

- 27-09-21 - 1 Formulier, 6 Itemgroepen, 75 Data-elementen, 1 Taal

Itemgroepen: Administrative Documentation, Physical Examination, Laboratory Data, Cytoreductive Surgery, Peritoneal Cancer Index, Type of surgery

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Woche 12

Eligibility Multiple Sclerosis NCT02290444

- 23-09-21 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Effects of Acthar on Recovery From Cognitive Relapses in MS; ODM derived from: https://clinicaltrials.gov/show/NCT02290444

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Eligibility Criteria

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 40 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Eligibility Question, Inclusion Criteria, Exclusion Criteria

This ODM-file contains the eligibility criteria. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - PK Dosing Date Time

- 20-09-21 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal

Itemgroep: PK Dosing

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Eligibility Hepatocellular Carcinoma NCT02149771

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Combination Treatment for Advanced Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02149771

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine

- 20-09-21 - 1 Formulier, 5 Itemgroepen, 33 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Head Impact Test (HIT-6) Score, IHS Headache Classification1, Migraine History, Previous Treatment for Migraine

This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 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

TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024 - Attack 1 Diary

- 20-09-21 - 1 Formulier, 9 Itemgroepen, 33 Data-elementen, 1 Taal

Itemgroepen: Date of Visit/Assessment, Migraine attack symptoms, IP, Migraine attack headache pain and symptoms, Medications taken, Ability to function, Investigational product accountability, Investigational Product, Language used in diary assessment

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Diary Card: General Symptoms Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396 - Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

- 20-09-21 - 1 Formulier, 5 Itemgroepen, 28 Data-elementen, 1 Taal

Itemgroepen: Identification, General Symptoms, Other General Symptoms, Medication, Administration

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Diary Card: General Symptoms

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4170G Macular Edema NCT00473382

- 20-09-21 - 1 Formulier, 7 Itemgroepen, 40 Data-elementen, 1 Taal

Itemgroepen: Patient administration, SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36), Adverse Event, Serious AE, Relevant Diagnostic Tests Performed, Tests, Additional Case Details:

Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

SERIOUS / NON-SERIOUS EXPEDITED ADVERSE EVENT REPORTING (DAY 0 - MONTH 36) CRFs Roche FVF4168G Macular Edema NCT00473330