- 5/28/19 - 1 form, 16 itemgroups, 166 items, 1 language
Itemgroups: Administrative documentation, Non-serious Adverse Event, Serious Adverse Event, COPD exacerbation, Concomitant Agent, Date of visit, Assessment Date, Fracture, Pharmacogenetics, Informed Consent; Sampling, Experimental drug, Compliance behavior, Experimental drug, Compliance behavior, Investigational Medicinal Product Documentation, Device Malfunction, Plain chest X-ray, Pneumonia, Evaluation, Event Log, Status, Serious Adverse Event, Status, Study Subject Participation Status
- 5/1/19 - 1 form, 16 itemgroups, 137 items, 1 language
Itemgroups: Logs ad Repeats, Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions, Non-serious Adverse Event (AE), Serious Adverse Events (SAE), Serious Adverse Event - Concomitant Medication, Serious Adverse Event - Medical Conditions/ Risk Factors, Serious Adverse Events - Relevant diagnostic results, Serious Adverse Events - Investigational Products, Serious Adverse Events - General narrative comments, Serious Adverse Events - Non clinical, Concomitant Medication, Electronically Transferred Lab Data, Vital signs, 12-Lead ECG, ECG Abnormalities, Repeat Pharmacokinetics Blood - GW856553
- 12/12/18 - 1 form, 13 itemgroups, 62 items, 1 language
Itemgroups: Administrative data, Section 1 Serious Adverse Events, Section 2 Seriousness, Section 3 Demography Data, Section 4 Recurrence of Adverse event after further investigational product, SECTION 5 Possible Causes of SAE other than Investigational Product(s), Section 6 Relevant Medical Conditions, SECTION 7 Other Relevant Risk Factors, SECTION 8 Relevant Concomitant Medications, SECTION 9 Details of Investigational Product(s), SECTION 10 Details of Relevant Assessments, SECTION 11 Narrative Remarks, Section 12 Additional/Follow-up information
- 12/10/18 - 1 form, 12 itemgroups, 39 items, 1 language
Itemgroups: Serious Adverse Event, Serious Adverse Event, Seriousness of Adverse Event, Serious Adverse Event, Demographics Domain, Serious Adverse Event, Experimental drug, Serious Adverse Event, Causations, Serious Adverse Event, Disease, Serious Adverse Event, Risk Factors, Serious Adverse Event, Concomitant Agent, Serious Adverse Event, Experimental Drug, Details, Serious Adverse Event, Evaluation, Details, Serious Adverse Event, Comment, Serious Adverse Event, Investigator Signature, Investigator Name
- 12/4/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Administrative data, Non-Serious Adverse Events
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 Non-Serious Adverse Events form. It has to be filled in if a Non-Serious Adverse Events occurs during study. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form. Any untoward medical occurrence in a patient or clinical investigation subject, temporally associated withthe use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. Examples of an AE include: Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. New condition(s) detected or diagnosedafter investigationalproduct administration even though it may have been present prior to the start of the study. Signs, symptoms, or the clinical sequelae of a suspected interaction. Signs, symptoms, or the clinical sequelae of asuspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). Examples of an AE do NOT include a/an: Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the procedure is an AE. Situations where an untoward medical occurrence did not occur (social and/or convenience admission to a hospital). Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen. The disease/disorderbeingstudied, or expected progression, signs, or symptoms of the disease/disorder being studied, unless more severe than expected for the subject's condition.