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ADVERSE EVENTS Roche H0650g Breast Cancer - ADVERSE EVENTS

- 29/05/17 - 1 modulo, 1 ItemGroup, 1 elemento, 1 linguaggio

ItemGroup: 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 - Logs/Repeats

- 13/08/20 - 1 modulo, 10 itemgroups, 157 elementi, 1 linguaggio

Itemgroups: 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

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

- 05/08/20 - 1 modulo, 11 itemgroups, 100 elementi, 1 linguaggio

Itemgroups: 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

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Serious Adverse Event (SAE)

- 17/07/19 - 1 modulo, 13 itemgroups, 51 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demography, Serious Adverse Event, Relationships, Experimental drug, Serious Adverse Event, Etiology aspects, Serious Adverse Event, Disease, Relevance, Serious Adverse Event, Risk factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental drug, Serious Adverse Event, Evaluation, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Non-Serious Adverse Events (NSAE)

- 12/07/19 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Non-serious Adverse Event

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer - SERIOUS ADVERSE EVENTS

- 23/05/17 - 1 modulo, 1 ItemGroup, 26 elementi, 1 linguaggio

ItemGroup: 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"

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

- 22/05/17 - 1 modulo, 1 ItemGroup, 18 elementi, 1 linguaggio

ItemGroup: 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"

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Log

- 26/04/21 - 1 modulo, 9 itemgroups, 117 elementi, 1 linguaggio

Itemgroups: Date of visit, Assessment Date, Event Log, Status, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Concomitant Agent, Adrenal Cortex Hormones, Blood product; Supportive care, Collection of blood specimen for laboratory procedure, Pharmacogenetic Test, Informed Consent, Pharmacogenetic Test, Informed Consent, Withdraw (activity)

Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Adverse Events; Serious Adverse Event; Prior and Concomitant Medications

- 03/09/19 - 1 modulo, 8 itemgroups, 61 elementi, 1 linguaggio

Itemgroups: Administrative, Are there any non-serious adverse events to report?, Non-Serious adverse Events, Serious Adverse Event #1, Serious Adverse Event #1 - Relevant Laboratory Data, Serious Adverse Event #1 - Signature, Prior and Concomitant Medications, Prior and Concomitant Medications

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Adverse Events

- 13/08/19 - 1 modulo, 2 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Adverse event

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

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

- 23/05/17 - 1 modulo, 1 ItemGroup, 26 elementi, 1 linguaggio

ItemGroup: 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

- 17/09/21 - 1 modulo, 3 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: 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.

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