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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 approved.

Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884

Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729

Master LTFU study will monitor the long-term safety and
tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.

LTFU for all cell and gene therapy studies

This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.

Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

Research Site

A LOng-term Follow-up Master Protocol for Participants who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)

To determine long-term safety of previous treatment with applicable cell and gene therapy products

To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product

To characterise the long-term persistence of the cell or gene therapy product.

Arms	Assigned Interventions
Experimental: AZD5851 Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884	Biological/Vaccine: AZD5851 Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.
AZD0754 Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729	Biological/Vaccine: AZD0754 Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

LTFU for all cell and gene therapy studies - LOCUS

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

Contacts

Contact