EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)

Clinical and Demographic Characteristics of Adult p atients with NEurofibromatosis in RUSsia

Open-label single-arm, non-interventional, multi-center, cohort study for evaluation of clinical and patient reported outcomes in routine care settings

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research site

Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia

To achieve the primary objectives of the study the following baseline clinical and demographic characteristics of patients will be collected or evaluated. The term ‘baseline’ means that the data is obtained at the inclusion into the study (Visit 1) during retrospective data collection from patient medical documentation or via interview with a patient on Visit 1, where applicable.

skin symptoms and
manifestations, tumor manifestations (except malignancies), neurological and cognitive
manifestations, cardiovascular manifestations, endocrine manifestations, orthopedic
manifestations (distinctive osseous lesions), ophthalmological manifestations, NF1
mutation, presence of NF1 diagnostic criteria in one of parents) (frequency distribution
at baseline)

malignancy, hypertension, vasculopathy, bone
symptoms, chronic neurological conditions, neuropathy, and pain

to be calculated
between the date when initially symptoms of PN appeared and the date of Visit 1

to be calculated between the
date of primary diagnosis of PN and the date of Visit 1

size, symptoms, previous medical interventions, surgeries or
treatments

if applicable, to be calculated in patients with at least one such
hospitalization

if applicable, to be calculated in patients with presence
of disability at Visit 1

if applicable, to be calculated in patients
with presence of disability at Visit 1

Clinical and Demographic Characteristics of Adult p atients with NEurofibromatosis in RUSsia - NEREUS

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Estimated Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact