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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Dose 3 (Primary)

- 10-01-19 - 1 Formulier, 18 Itemgroepen, 79 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Dose 3 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 3 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 3 - Other Local Symptoms, Dose 3 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 3 - Other General Symptoms, Dose 3 - Medication, Reminder
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

ICHOM Hip and Knee Osteoarthritis - Optional measures - Patient-reported

- 30-04-20 - 1 Formulier, 2 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Optional measures
ICHOM Hip and Knee Osteoarthritis Study description: ICHOM Hip and Knee Osteoarthritis data collection Version 2.2.1 Revised: April 10th, 2017 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. For Hip and Knee Osteoarthritis, the following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions : All patients seeking treatment for osteoarthritis of the hip or knee, whether surgical or non-surgical Treatment Approaches: Non-Surgical: Lifestyle intervention | Patient education | Physiotherapy | Walking aid or orthosis | Topical and oral medication | Intra-articular injection Surgical: Osteotomy | Joint replacement | Other forms of surgical treatment This document contains the Optional measures - Patient-reported form. ICHOM includes the option of more frequent collection of some measures for direct use in clinical care. For example, more frequent collection of functional outcomes may be helpful following surgery or major changes in treatment. ICHOM leave the timing of this data collection to individual institutions or clinicians. Collecting Patient-Reported Outcome Measures: Hip Disability and Osteoarthritis Outcome Score - Physical Function Shortform (HOOS-PS). http://www.koos.nu/ Knee Injury and Osteoarthritis Outcome Score - Physical Function Shortform (KOOS-PS). http://www.koos.nu/ Veterans RAND 12 (VR-12) or Short Form 12 Health Survey (SF- 12). As a request for access and an agreement to terms of use are necessary before access, the actual questions of these questionnaires are not part of this version of the standard set. EuroQol-5D descriptive system (EQ- 5D-3L) and visual analogue scale (EQ-VAS). As a license is needed for use of EuroQol questionnaires, the actual questions are not part of this version of the standard set. *For a description of an algorithm to convert between the EQ-5D-3L and SF-12, please see: Le QA. Probabilistic mapping of the health status measure SF-12 responses and EQ-5D using the US-population-based scoring models. Qual Life Res. 2014 Mar; 23(2): 459-66. Please see the above Veterans RAND website for help converting the VR-12 to the SF-12. For this standard set ICHOM was supproted by Hoag Orthopedic Institute, the Connecticut Joint Replacement Institute, and Harvard Pilgrim Health Care and Arthritis Research. Publication: Rolfson O, Wissig S, van Maasakkers L, et al. Defining an International Standard Set of Outcome Measures for Patients With Hip or Knee Osteoarthritis: Consensus of the International Consortium for Health Outcomes Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res (Hoboken). 2016;68(11):1631–1639. doi:10.1002/acr.22868 For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Dose 1 (Primary)

- 10-01-19 - 1 Formulier, 18 Itemgroepen, 79 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Dose 1 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 1 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 1 - Other Local Symptoms, Dose 1 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 1 - Other General Symptoms, Dose 1 - Medication, Reminder
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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