All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.

Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study

ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population

ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population

Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population

Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab

Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab

Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab

Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.

Safety Population

Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.

Safety Population

Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.

Data not summarized, study terminated early

Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.

Data not summarized, study terminated early

PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Data not summarized, study terminated early

PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.

Data not summarized, study terminated early