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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Tobacco use, HIV screen

- 12/4/18 - 1 form, 3 itemgroups, 6 items, 1 language
Itemgroups: Administrative data, HISTORY OF TOBACCO USE, SEROLOGY - HIV SCREEN
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the history of tobacco use and the serology - HIV screen form. It has to be filled in for screening.

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

- 9/27/16 - 1 form, 16 itemgroups, 104 items, 1 language
Itemgroups: 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

- 9/27/16 - 1 form, 10 itemgroups, 40 items, 1 language
Itemgroups: 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

Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425 - Unscheduled Visit, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

- 9/27/16 - 1 form, 11 itemgroups, 42 items, 1 language
Itemgroups: Header, Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Radiology, Study Drug Dispensed Applicable, 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: Unscheduled Visit

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

- 9/27/16 - 1 form, 8 itemgroups, 27 items, 1 language
Itemgroups: Vital Assessment, Physical Examination, Pregnancy Test, Hematology, Biochemistry/Proteomics, Cigarette Smoking Status, Tobacco/Nicotine Use Status, Open-label Tarceva 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: Open-label Baseline Assessments

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