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Eligibility Posttraumatic Stress Disorders Multiple Sclerosis NCT01743664

- 15-06-21 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01743664

Eligibility Non-Small Cell Lung Cancer NCT02109653

- 09-04-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT02109653

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Serious Adverse Event

- 15-03-21 - 1 Formulier, 10 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Demographic Information, Description, Study Drug, Hospitalization, Death, Previous and Concomitant Medication, Medical History and Concomitant Disease, SAE Follow-Up Information, Investigator & Monitor
Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on serious adverse events, and is to be filled in as necessary during the study, in addition to the AE form, and consists of a complimentary part and a follow-up part.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Adverse events

- 23-01-21 - 1 Formulier, 2 Itemgroepen, 27 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Adverse events
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This document is to be filled out if and whenever an adverse event occurs during the study period.

Eligibility Polyarticular-course Juvenile Idiopathic Arthritis (JIA) NCT01550003

- 22-01-21 - 1 Formulier, 2 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Pediatric Arthritis Study of Certolizumab Pegol; ODM derived from: https://clinicaltrials.gov/show/NCT01550003

Eligibility Rheumatoid Arthritis NCT01197534

- 22-01-21 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.; ODM derived from: https://clinicaltrials.gov/show/NCT01197534

Eligibility Oral Mucositis NCT01265810

- 21-01-21 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacogenetic Research

- 09-01-21 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, PGx-Pharmacogenetic Research Consent, PGx-Pharmacogenetic Research Withdrawal of Consent
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Concomitant medication

- 09-01-21 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Concomitant Medications
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out, if concomitant medication has been taken by subject during the study.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Study Conclusion and Pregnancy Information

- 18-12-20 - 1 Formulier, 3 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Study Conclusion, Pregnancy information
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacokinetics

- 18-12-20 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Dosing date and time, Pharmacokinetics Blood
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the P1 D1 and P2 D1 Visit.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Electronically transferred lab data

- 18-12-20 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Safety Labs
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Screening, the P1 D-1, P1 D1, P2 D-1, P2 D1, the Follow-Up Visits and in case of repeat measurements.

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