Trial Outcomes & Findings for A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study (NCT NCT01519778)

NCT ID: NCT01519778

Last Updated: 2018-08-29

Results Overview

Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: 24-31 days
• Results posted on: 2018-08-29

Participant Flow

Participant milestones

Measure	TR-701 FA TR701 FA: 1 tablet 200 mg once daily
Overall Study STARTED	200
Overall Study COMPLETED	186
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	TR-701 FA TR701 FA: 1 tablet 200 mg once daily
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	10
Overall Study Physician Decision	1

Baseline Characteristics

A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Baseline characteristics by cohort

Measure	TR-701 FA n=200 Participants TR701 FA: 1 tablet 200 mg once daily
Age, Continuous	39.5 years STANDARD_DEVIATION 13.04 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24-31 days

Population: Patients receiving any amount of study drug

Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).

Outcome measures

Measure	TR-701 FA n=200 Participants TR701 FA: 1 tablet 200 mg once daily
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	91 participants

Adverse Events

TR-701 FA

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	TR-701 FA n=200 participants at risk TR701 FA: 1 tablet 200 mg once daily
Respiratory, thoracic and mediastinal disorders hemoptysis	0.50% 1/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Infections and infestations thrombophlebitis septic	0.50% 1/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.

Other adverse events

Measure	TR-701 FA n=200 participants at risk TR701 FA: 1 tablet 200 mg once daily
Gastrointestinal disorders Nausea	11.0% 22/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Gastrointestinal disorders diarrhea	6.5% 13/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Infections and infestations cellulitis	5.0% 10/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Infections and infestations abscess	4.5% 9/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Gastrointestinal disorders vomiting	4.5% 9/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Nervous system disorders dizziness	3.5% 7/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Nervous system disorders headache	3.5% 7/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
General disorders chills	2.0% 4/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Gastrointestinal disorders constipation	2.0% 4/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.
Nervous system disorders somnolence	2.0% 4/200 • From the Informed Consent Form signature through the late follow-up visit, up to 32 days.

Additional Information

Carisa De Anda, Phd, Vice President Clinical Research

Cubist Pharmaceuticals

Phone: 8583522639

Email: carisa.deanda@cubist.com

Results disclosure agreements

• Principal investigator is a sponsor employee Trius intends to pursue publication of the results of the study in cooperation with a lead Investigator, subject to the terms and conditions of the clinical study agreement between Trius and Investigators. Trius written approval is required for publication of any data subsets. Final authorship will be determined in accordance with the International Conference of Medical Journal Editors definition of authorship.
• Publication restrictions are in place

Restriction type: OTHER