Trial Outcomes & Findings for Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma (NCT NCT00790452)

Results Overview

Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

VTE evaluation with study visits (4 weeks) for up to 2 years

Results posted on

2011-12-08

Participant Flow

Recruitment Period: October 28, 2008 to October 26, 2009. All patient recruitment attempted to UT MD Anderson Cancer Center.

The only participant enrolled was removed from the study due to a drug supply issue, and the study terminated early.

Participant milestones

Participant milestones
Measure	Group 1 (Aspirin) Aspirin 325 mg/day orally	Group 2 (Placebo) Tablet/day orally
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Aspirin) Aspirin 325 mg/day orally	Group 2 (Placebo) Tablet/day orally
Overall Study Drug supply issue	1	0

Baseline Characteristics

Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Aspirin) n=1 Participants Aspirin 325 mg/day orally	Group 2 (Placebo) Tablet/day orally	Total n=1 Participants Total of all reporting groups
Age Continuous	53 years n=5 Participants	—	53 years n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: VTE evaluation with study visits (4 weeks) for up to 2 years

Population: Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.

Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.

Outcome measures

Outcome data not reported

Adverse Events

Group 1 (Aspirin)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Victor A Levin, MD, BS / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place