Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs)

Thromboembolic and/or ischemic events (TIEs) were defined as any of the following events: disseminated intravascular coagulation (Grade \[Gr\]\>=3); acute coronary syndrome (Gr \>=3); cardiac arrest (Gr \>=4); myocardial infarction (Gr \>=3); Cardiac troponin I increased (Gr 3); ischemia cerebrovascular (Gr \>=1 and associated with lesion\[s\]); portal vein thrombosis (Gr \>=2); ischemic stroke (Gr \>=1 and associated with lesion\[s\]); transient ischemic attacks (Gr 2); purpura (Gr \>=2); superior vena cava syndrome (Gr \>=1); thromboembolic event (Gr \>=2); visceral arterial ischemia (Gr \>=2); peripheral arterial ischemia (Gr \>=3). TIEs were graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the respective event to count as a treatment-emergent TIE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.

Time frame: Day 1 through day of discharge (Day 8)

Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; or was life threatening (immediate risk of death); or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. Any such events occurring following the start of treatment or increasing in severity were counted as treatment-emergent.

Time frame: Day 1 through follow-up visit (Day 43)

Number of Participants With Treatment-Emergent Adverse Events (AEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. For the respective event to count as a treatment-emergent AE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.

Time frame: Day 1 through day of discharge (Day 8)

Number of Participants With Treatment-Emergent Laboratory Abnormalities

Laboratory safety parameters included hematology, blood chemistry, prothrombin time/international normalized ratio (PT/INR), fibrinogen, antithrombin III (ATIII), Protein S level, Protein C activity, cardiac troponin I, D-dimer, and urinalysis. The number of participants with laboratory test abnormalities meeting specified criteria without regard to baseline abnormality was assessed. Any abnormalities occurring after the administration of treatment and increasing in severity from baseline value were counted as treatment-emergent.

Time frame: Day 1 through Day 8 (or discharge) for D-dimer laboratory test and urinalysis; Day 1 through Day 4 for all other laboratory tests

Number of Participants With Changes From Baseline in Physical Examination

Comprehensive and targeted physical examinations included general appearance, HEENT (head, eyes, ears, nose and throat), skin, heart (auscultation), lungs (auscultation), abdomen (palpitation and auscultation), and extremities with attention to swelling, general or localized tenderness, entire leg or calf swelling, edema, and collateral superficial veins. The results of the comprehensive and targeted physical examinations were combined to evaluate the changes from baseline through Day 8 (or discharge) for each site parameter according to the categories: positive change (abnormal to normal); no change (normal to normal or abnormal to abnormal); negative change (normal to abnormal). Parameters with at least 1 participant meeting the positive/negative change from baseline criteria are presented here.

Time frame: Baseline (pre-dose), Day 2, Day 3, Day 4, Day 8/discharge

Change From Baseline for Body Temperature

Body temperature was measured by oral, tympanic, axillary or temporal method.

Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge

Change From Baseline for Supine Respiratory Rate

Respiratory rate was measured after 5 minutes rest in supine position by observing and counting the respirations of the participant for 30 seconds and multiplied by 2. The use of an automated device for measuring respiratory rate was acceptable.

Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge

Change From Baseline for Supine Systolic and Diastolic Blood Pressure

Supine blood pressure (BP, systolic and diastolic) was measured with the participant's arm supported at the level of the heart and recorded to the nearest milliliters of mercury (mmHg) after 5 minutes of rest whenever possible and as permitted by the participant's medical condition.

Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge

Change From Baseline for Supine Pulse Rate

The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.

Time frame: Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge

Number of Participants With Electrocardiogram (ECG) Qualitative Results

The electrocardiogram (ECG) results over time were compared to baseline and assessed by the investigator as "less abnormal", "no significant change", or "more abnormal".

Time frame: Baseline (pre-dose), Day 2, Day 4, Day 8/discharge