Concomitant Medication ×
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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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- 4/21/18 - 1 form, 14 itemgroups, 133 items, 1 language
Itemgroups: Adverse Events, Concomitant Medication, Demographics, Disease Characteristics, Disposition, ECG, Laboratory, Laboratory Data, Medical History, Patient Reported Outcome, Substance Use, Surgery, Tumor Response, Vital Signs
- 2/24/20 - 1 form, 15 itemgroups, 131 items, 1 language
Itemgroups: Date of Visit/ Assessment, Log Status, Concomitant Medications, Non-Serious Adverse Event, Serious Adverse Event - Type of Report, Serious Adverse Event - Randomisation, Serious Adverse Event, Serious Adverse Event - Intensity Changes, Serious Adverse Event - Seriousness, Serious Adverse Event - Relevant Concomitant/ Treatment Medications, Serious Adverse Events - Relevant Medical Conditions/ Risk Factors, Serious Adverse Event - Relevant Diagnostic Results, Serious Adverse Event - Rechallenge, Serious Adverse Event - Investigational Product, Serious Adverse Event - Non clinical
- 2/1/20 - 1 form, 16 itemgroups, 156 items, 1 language
Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG
- 12/5/19 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Administrative Data, Concomitant medication
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on Identifier: NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Concomitant medication form for documentation of any concomitant agents taken throughout the study. In case of concomitant medication affecting ocular health, the information about those medications should be given (additionally?) in a second version of this form concerning concomitant medication affecting ocular health.