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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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.

A Rollover study for patients who received tremelimumab in other protocols, to allow the patients access to tremelimumab until this agent becomes commercially available or development is discontinued.

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

15 mg/kg IV every 3 months as long as required

Research Site

A Rollover Protocol For Patients Who Received tremelimumab (CP-675,206 ) In Other Protocols

Sex: Female, Male

Age Categorical

Race (NIH/OMB)

One participant received no study medication and was excluded from data analysis

Safety Endpoints: Serious adverse events to tremelimumab.

Safety Endpoints: Grade 3 or 4 tremelimumab-related adverse events  to tremelimumab.

Safety Endpoints: Hypersensitivity reactions to tremelimumab.

Response at End of Study

Efficacy Endpoints: Tumor status: alive with disease (AWD) or no evidence of disease (NED)

Efficacy Endpoints: Survival

Kaplan-Meier Median

Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first

Disease Free Survival

Overall Study

Total Consented/screened 38 subjects (1 of which was dead before enter any treatment), so total entered treatment 37 subjects. Subjects were assigned to
treatment if they met all inclusion. 32 subjects withdrawn from this study. 6 subjects completed the study.
Final Efficacy/Safety analysis 37 subjects.

A Rollover study for patients who received tremelimumab in other protocols, to allow the patients access to tremelimumab until this agent becomes commercially available or development is discontinued.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Redacted SAP

Redacted CSP

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator