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Main CRF (Treatment Period 1, Day 3-6) - GSK Milveterol COPD 100527

- 20/09/21 - 1 modulo, 5 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: Vital Signs Day 3-6, 12-Lead Electrocardiogram Day 3-6, FEV1 Day 3-6, Potassium Day 5-6, Investigational Product Day 3-6
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

Eligibility Schizophrenia NCT00686140

- 20/09/21 - 1 modulo, 2 itemgroups, 12 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00686140

Random Drug Screening (Urine) Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 5 PK Visit (Visit 9)

- 20/09/21 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: DRUG SCREENING (URINE)
Study Part: Random Drug Screening (Urine) Week 5 PK Visit (Visit 9). 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

Maintenance therapy R2 AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441 - Maintenance therapy R2 AIEOP-BFM ALL 2009 NCT01117441

- 15/03/21 - 1 modulo, 3 itemgroups, 21 elementi, 1 linguaggio
Itemgroups: Patient Information, Examinations, Identification and Signature
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Documentation part. Clinical Trial Number: NCT01117441.

60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - 60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS

- 15/03/21 - 1 modulo, 1 ItemGroup, 11 elementi, 1 linguaggio
ItemGroup: CONCOMITANT MEDICATIONS
Study part: 60 Days Post- Treatment Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - CONCOMITANT MEDICATIONS

- 15/03/21 - 1 modulo, 1 ItemGroup, 11 elementi, 1 linguaggio
ItemGroup: CONCOMITANT MEDICATIONS
Study part: Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING) Roche H0650g Breast Cancer - PRIOR TREATMENT FOR BREAST CANCER (ADJUVANT SETTING)

- 15/03/21 - 1 modulo, 3 itemgroups, 18 elementi, 1 linguaggio
Itemgroups: Chemotherapy, Therapeutic regimen, ADJUVANT THERAPY
Study part: Prior treatment for breast cancer (Adjuvant setting). A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

PREVIOUS/ CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - PREVIOUS/ CONCOMITANT MEDICATIONS

- 15/03/21 - 1 modulo, 1 ItemGroup, 10 elementi, 1 linguaggio
ItemGroup: CONCOMITANT MEDICATIONS
Study part: Previous/ Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

PRIOR TREATMENT FOR METASTATIC BREAST CANCER Roche H0650g Breast Cancer - PRIOR TREATMENT FOR METASTATIC BREAST CANCER

- 15/03/21 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: RADIOTHERAPY, HORMONAL THERAPY, METASTASE
Study part: Prior treatment for metastatic breast cancer. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Prior WM Therapy

- 08/02/21 - 1 modulo, 3 itemgroups, 19 elementi, 1 linguaggio
Itemgroups: Administrative Data, Previous WM Treatment Status, Prior Waldenstrom's Macroglobulinemia Therapy
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Prior Anti-Cancer procedures

- 26/03/20 - 1 modulo, 4 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Administrative Data, Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy, Prior Anti-Cancer Therapy: Radiotherapy, Prior anti-cancer medical/surgical procedures
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the prior Anti-Cancer procedures. It has to be filled in for screening.

Sentinel Common Data Model Procedure

- 25/08/19 - 1 modulo, 1 ItemGroup, 8 elementi, 1 linguaggio
ItemGroup: Procedure
Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Procedure Table contains one record per unique combination of PatID, EncounterID, PX, and PX_CodeType. This table should capture all uniquely recorded procedures for all encounters.

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