Sökresultat - Portal för medicinska datamodeller (MDM-portal)

Breast Cancer Adverse Event NCT00382070 - rade 2 and 3 Adverse Event Report Breast Cancer NCT00382070 NSABP B-42

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk

Item-grupper: Header, Adverse event

NSABP Protocol B-42 - Grade 2 and 3 Adverse Event (AE) Report Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer NCT00382070 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17ADF05F-DB75-341D-E044-0003BA3F9857

ADVERSE EVENTS Roche H0650g Breast Cancer - ADVERSE EVENTS

- 2017-05-29 - 1 Formulär, 1 Item-grupp, 1 Dataelement, 1 Språk

Item-grupp: Adverse Events

Study part: Adverse Events. 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"

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Liver Events

- 2020-08-05 - 1 Formulär, 11 Item-grupper, 100 Dataelement, 1 Språk

Item-grupper: Date of visit, Liver, Adverse event, Evaluation, Liver, Adverse Event, Liver, Adverse Event, Experimental drug, Liver, Adverse event, Pharmacokinetic aspects, Liver, Adverse Event, Disease, Liver, Adverse Event, Drug-related disorder, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer - SERIOUS ADVERSE EVENTS

- 2017-05-23 - 1 Formulär, 1 Item-grupp, 26 Dataelement, 1 Språk

Item-grupp: SERIOUS ADVERSE EVENTS

Study part: Serious adverse events. 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"

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Logs/Repeats

- 2020-08-13 - 1 Formulär, 10 Item-grupper, 157 Dataelement, 1 Språk

Item-grupper: Event Log, Repeat, Echocardiography, Multiple gated acquisition scanning, Vital signs, Repeat, 12 lead ECG, Unscheduled, Repeat, 12 lead ECG, Abnormality, Pharmacokinetic aspects, Unscheduled, Repeat, Experimental drug, Unscheduled, Repeat, Adverse event, Repeat, Serious Adverse Event, Concomitant Agent, Repeat

Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

NON-SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer - NON-SERIOUS ADVERSE EVENTS

- 2017-05-22 - 1 Formulär, 1 Item-grupp, 18 Dataelement, 1 Språk

Item-grupp: Non-serious Adverse Event

Study part: Non- serious adverse events. 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"

Breast Cancer DCIS NCT00053898 - ADVERSE EVENT FORM Breast Cancer NCT00053898 NSABP B-35

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Header, Adverse Events

NSABP B-35 ADVERSE EVENT FORM (AE) Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy NCT00053898 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A056A959-00D2-32FA-E034-080020C9C0E0

Breast Cancer NCT00433589 Toxicity - Adverse Events Breast Cancer NCT00433589 CTCAE v3.0

- 2015-03-27 - 1 Formulär, 2 Item-grupper, 29 Dataelement, 1 Språk

Item-grupper: Header, CTCAE

Adverse Events - CTCAE v3.0 Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes NCT00433589 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1903495E-EB08-0BEB-E044-0003BA3F9857

Breast Cancer NCT00408408 Toxicity - Adverse Event Form Breast Cancer NSABP B-40 NCT00408408

- 2015-03-24 - 1 Formulär, 3 Item-grupper, 21 Dataelement, 1 Språk

Item-grupper: Header, Reporting Period, Adverse Event

NSABP Protocol B-40 - Adverse Event Form A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens NCT00408408 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1ABDA8E9-5BF6-6122-E044-0003BA3F9857

Adverse Events Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Adverse Events

- 2016-02-17 - 1 Formulär, 1 Item-grupp, 15 Dataelement, 1 Språk

Item-grupp: Adverse Events Form

Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

60 DAY POST-TREATMENT SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer - 60 DAY POST-TREATMENT SERIOUS ADVERSE EVENTS

- 2017-05-23 - 1 Formulär, 1 Item-grupp, 26 Dataelement, 1 Språk

Item-grupp: SERIOUS ADVERSE EVENTS

Study part: 60 Day Post- Treatment Serious Adverse Events. 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"

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

- 2021-09-17 - 1 Formulär, 3 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of Visit/Assessment, Adverse Event/concomitant medication/repeat evaluation

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 logs and repeats.

Nyckelord

Innehållsförteckning

Valda datamodeller