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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - CRF Tracking/Review Forms

- 22.08.19 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Clinical Trial Regulatory Tracking Document
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612 - Pregnancy notification form (subject's partner)

- 07.12.18 - 1 Formular, 7 Itemgruppen, 42 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Mothers relevant medical/family history, Number of previous pregnancies, Fathers relevant medical/family history, DRUG EXPOSURES, Withdraw from study, REPORTING INVESTIGATOR INFORMATION
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 Pregnancy notification form (subject's partner). Complete this form for each subject's partner who becomes pregnant during the study period. This form should be completed according to the protocol reporting requirements. Complete this form for each subject's partner who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. Original pages should remain with the subject's Case Report Form. Note: This form does not routinely need to be completed for subject's partner pregnancy unless there is specific instruction to do so stated in the protocol.

Visit 0 GIMEMA CML0408 NCT00769327 - Visit 0

- 20.09.21 - 1 Formular, 4 Itemgruppen, 55 Datenelemente, 2 Sprachen
Itemgruppen: Enrollment, Symptoms, Physical Examination, Complete Blood Count
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the visit 0 form.

Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277) - Annex 2: RAP version of cleaning report defining ELIM code criterion to use

- 20.09.21 - 1 Formular, 13 Itemgruppen, 95 Datenelemente, 1 Sprache
Itemgruppen: RAP version of cleaning report defining ELIM code criterion to use, Summary, Serious adverse events, Pregnancies, Elimination from safety and immunology analysis, Elimination from immunology analysis, Extra Elimination from analysis, Other points to consider - Inform Consent procedure not respected, Other points to consider, Replacement Treatment Number, Pending Queries not to be resolved, Others, Signature
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Bronchoscopy Nursing Report Hematology UKM - Bronchoscopy Nursing Repor

- 27.03.17 - 1 Formular, 3 Itemgruppen, 24 Datenelemente, 2 Sprachen
Itemgruppen: Patient demographics, Bronchoscopy, Footer module
Bronchoscopy Nursing Repor converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by: Prof. Dr. Berdel

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