Trial Outcomes & Findings for Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage (NCT NCT02687191)

NCT ID: NCT02687191

Last Updated: 2019-04-17

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2019-04-17

Participant Flow

Not all the 15 pre-specified dose groups (possible doses based on Bayesian modified continual reassessment method \[mCRM\]) were expected to be studied. The actual doses were determined by mCRM and safety review. Study results were reported for the 6 actual dose groups allocated with participants.

Participant milestones

Participant milestones
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Overall Study STARTED	3	3	3	6	3	3
Overall Study COMPLETED	3	2	2	5	2	2
Overall Study NOT COMPLETED	0	1	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Overall Study Death	0	1	1	0	1	1
Overall Study Withdrawal by Subject	0	0	0	1	0	0

Baseline Characteristics

Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.	Total n=21 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 5.5 • n=5 Participants	65.7 years STANDARD_DEVIATION 5.5 • n=7 Participants	62.3 years STANDARD_DEVIATION 11.9 • n=5 Participants	62.2 years STANDARD_DEVIATION 8.1 • n=4 Participants	66.7 years STANDARD_DEVIATION 3.8 • n=21 Participants	67.7 years STANDARD_DEVIATION 9.6 • n=8 Participants	62.3 years STANDARD_DEVIATION 9 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	14 Participants n=8 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 through day of discharge (Day 8)

Population: All participants who received the treatment of PF-05230907.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 through follow-up visit (Day 43)

Population: All participants who received the treatment of PF-05230907.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 through day of discharge (Day 8)

Population: All participants who received the treatment of PF-05230907.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (AEs)	2 Participants	3 Participants	3 Participants	5 Participants	3 Participants	3 Participants

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Treatment-Emergent Laboratory Abnormalities	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	3 Participants

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Changes From Baseline in Physical Examination Lungs: Negative change, Day 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Neurological: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Neurological: Positive change, Day 3	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Neurological: Positive change, Day 4	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Throat: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Positive change, Day 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Positive change, Day 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Positive change, Day 8/discharge	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Eyes: Negative change, Day 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Eyes: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Eyes: Positive change, Day 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Eyes: Positive change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Head: Negative change, Day 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Head: Negative change, Day 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Head: Positive change, Day 8/discharge	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Heart: Negative change, Day 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Heart: Negative change, Day 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Heart: Negative change, Day 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Heart: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Abdomen: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Negative change, Day 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Negative change, Day 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Negative change, Day 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Extremities: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Lungs: Negative change, Day 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Lungs: Negative change, Day 8/discharge	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Lungs: Positive change, Day 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Lungs: Positive change, Day 8/discharge	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Neurological: Positive change, Day 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Changes From Baseline in Physical Examination Skin: Positive change, Day 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Skin: Positive change, Day 4	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Changes From Baseline in Physical Examination Skin: Positive change, Day 8/discharge	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified time point.

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

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Change From Baseline for Body Temperature Day 1 (5 min)	0.1 Degree Celsius (°C) Standard Deviation 0.10	-0.2 Degree Celsius (°C) Standard Deviation 0.21	0.4 Degree Celsius (°C) Standard Deviation 0.57	-0.1 Degree Celsius (°C) Standard Deviation 0.52	0.4 Degree Celsius (°C) Standard Deviation 0.55	0.1 Degree Celsius (°C) Standard Deviation 0.10
Change From Baseline for Body Temperature Day 4	0.1 Degree Celsius (°C) Standard Deviation 0.26	0.0 Degree Celsius (°C) Standard Deviation 0.06	1.1 Degree Celsius (°C) Standard Deviation 0.99	0.4 Degree Celsius (°C) Standard Deviation 0.85	0.7 Degree Celsius (°C) Standard Deviation 1.43	0.1 Degree Celsius (°C) Standard Deviation 0.25
Change From Baseline for Body Temperature Day 1 (45 min)	0.1 Degree Celsius (°C) Standard Deviation 0.10	-0.2 Degree Celsius (°C) Standard Deviation 0.26	0.4 Degree Celsius (°C) Standard Deviation 0.57	-0.1 Degree Celsius (°C) Standard Deviation 0.28	0.4 Degree Celsius (°C) Standard Deviation 0.61	0.0 Degree Celsius (°C) Standard Deviation 0.30
Change From Baseline for Body Temperature Day 2	0.4 Degree Celsius (°C) Standard Deviation 0.76	0.5 Degree Celsius (°C) Standard Deviation 0.35	0.2 Degree Celsius (°C) Standard Deviation 1.36	0.5 Degree Celsius (°C) Standard Deviation 0.98	1.0 Degree Celsius (°C) Standard Deviation 1.10	0.0 Degree Celsius (°C) Standard Deviation 0.35
Change From Baseline for Body Temperature Day 3	0.6 Degree Celsius (°C) Standard Deviation 0.72	0.5 Degree Celsius (°C) Standard Deviation 0.20	1.1 Degree Celsius (°C) Standard Deviation 0.45	1.1 Degree Celsius (°C) Standard Deviation 1.06	0.9 Degree Celsius (°C) Standard Deviation 1.63	0.1 Degree Celsius (°C) Standard Deviation 0.65
Change From Baseline for Body Temperature Day 8/discharge	-0.2 Degree Celsius (°C) Standard Deviation 0.35	0.1 Degree Celsius (°C) Standard Deviation 0.28	0.5 Degree Celsius (°C) Standard Deviation 0.70	0.4 Degree Celsius (°C) Standard Deviation 0.78	-0.1 Degree Celsius (°C) Standard Deviation 0.28	-0.4 Degree Celsius (°C) Standard Deviation 0.68

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified time point.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Change From Baseline for Supine Respiratory Rate Day 8/discharge	-2.5 respiration per minute Standard Deviation 0.71	2.5 respiration per minute Standard Deviation 0.71	-2.0 respiration per minute Standard Deviation 2.65	1.2 respiration per minute Standard Deviation 2.71	-1.0 respiration per minute Standard Deviation 1.41	-2.7 respiration per minute Standard Deviation 2.89
Change From Baseline for Supine Respiratory Rate Day 1 (5 min)	0.0 respiration per minute Standard Deviation 4.00	3.7 respiration per minute Standard Deviation 3.51	-1.3 respiration per minute Standard Deviation 2.52	-1.5 respiration per minute Standard Deviation 3.00	-0.3 respiration per minute Standard Deviation 0.58	0.7 respiration per minute Standard Deviation 3.06
Change From Baseline for Supine Respiratory Rate Day 1 (45 min)	-2.3 respiration per minute Standard Deviation 2.08	5.7 respiration per minute Standard Deviation 1.53	-0.7 respiration per minute Standard Deviation 2.52	-1.2 respiration per minute Standard Deviation 2.93	4.0 respiration per minute Standard Deviation 6.93	0.0 respiration per minute Standard Deviation 1.00
Change From Baseline for Supine Respiratory Rate Day 2	-1.7 respiration per minute Standard Deviation 0.58	5.0 respiration per minute Standard Deviation 3.61	-3.0 respiration per minute Standard Deviation 1.00	-0.8 respiration per minute Standard Deviation 2.86	0.0 respiration per minute Standard Deviation 2.00	-0.7 respiration per minute Standard Deviation 0.58
Change From Baseline for Supine Respiratory Rate Day 3	-1.0 respiration per minute Standard Deviation 3.00	5.3 respiration per minute Standard Deviation 2.89	-1.0 respiration per minute Standard Deviation 2.65	0.0 respiration per minute Standard Deviation 4.15	1.7 respiration per minute Standard Deviation 2.89	0.3 respiration per minute Standard Deviation 2.52
Change From Baseline for Supine Respiratory Rate Day 4	0.3 respiration per minute Standard Deviation 2.52	4.0 respiration per minute Standard Deviation 3.46	-0.7 respiration per minute Standard Deviation 3.79	-1.0 respiration per minute Standard Deviation 2.19	1.3 respiration per minute Standard Deviation 4.16	-0.7 respiration per minute Standard Deviation 1.15

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified category.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 2	-3.3 milliliters of mercury (mmHg) Standard Deviation 8.14	-7.3 milliliters of mercury (mmHg) Standard Deviation 17.01	-11.0 milliliters of mercury (mmHg) Standard Deviation 11.53	-29.8 milliliters of mercury (mmHg) Standard Deviation 25.63	-14.0 milliliters of mercury (mmHg) Standard Deviation 8.54	0.7 milliliters of mercury (mmHg) Standard Deviation 18.58
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 3	-14.3 milliliters of mercury (mmHg) Standard Deviation 19.09	5.3 milliliters of mercury (mmHg) Standard Deviation 17.93	12.0 milliliters of mercury (mmHg) Standard Deviation 7.21	-36.2 milliliters of mercury (mmHg) Standard Deviation 26.16	5.3 milliliters of mercury (mmHg) Standard Deviation 34.56	-15.7 milliliters of mercury (mmHg) Standard Deviation 3.79
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 4	-12.0 milliliters of mercury (mmHg) Standard Deviation 17.09	6.3 milliliters of mercury (mmHg) Standard Deviation 30.37	-6.0 milliliters of mercury (mmHg) Standard Deviation 12.49	-32.5 milliliters of mercury (mmHg) Standard Deviation 25.84	7.3 milliliters of mercury (mmHg) Standard Deviation 11.93	-27.7 milliliters of mercury (mmHg) Standard Deviation 17.21
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 8/discharge	-18.0 milliliters of mercury (mmHg) Standard Deviation 5.66	-1.0 milliliters of mercury (mmHg) Standard Deviation 26.87	-5.0 milliliters of mercury (mmHg) Standard Deviation 18.03	-22.8 milliliters of mercury (mmHg) Standard Deviation 50.01	18.5 milliliters of mercury (mmHg) Standard Deviation 3.54	-14.3 milliliters of mercury (mmHg) Standard Deviation 6.35
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 1 (5 min)	-9.0 milliliters of mercury (mmHg) Standard Deviation 15.59	10.7 milliliters of mercury (mmHg) Standard Deviation 11.02	-7.3 milliliters of mercury (mmHg) Standard Deviation 15.53	-21.6 milliliters of mercury (mmHg) Standard Deviation 20.94	5.3 milliliters of mercury (mmHg) Standard Deviation 9.24	6.3 milliliters of mercury (mmHg) Standard Deviation 2.08
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 2	-0.7 milliliters of mercury (mmHg) Standard Deviation 12.06	-8.0 milliliters of mercury (mmHg) Standard Deviation 4.00	-4.7 milliliters of mercury (mmHg) Standard Deviation 21.73	-26.2 milliliters of mercury (mmHg) Standard Deviation 32.39	-7.3 milliliters of mercury (mmHg) Standard Deviation 1.53	-5.7 milliliters of mercury (mmHg) Standard Deviation 8.74
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 1 (45 min)	-11.3 milliliters of mercury (mmHg) Standard Deviation 17.62	7.3 milliliters of mercury (mmHg) Standard Deviation 21.83	9.3 milliliters of mercury (mmHg) Standard Deviation 1.15	-27.0 milliliters of mercury (mmHg) Standard Deviation 25.11	1.7 milliliters of mercury (mmHg) Standard Deviation 7.64	2.0 milliliters of mercury (mmHg) Standard Deviation 2.65
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 3	-7.0 milliliters of mercury (mmHg) Standard Deviation 6.24	-4.3 milliliters of mercury (mmHg) Standard Deviation 11.93	5.0 milliliters of mercury (mmHg) Standard Deviation 8.66	-28.2 milliliters of mercury (mmHg) Standard Deviation 24.81	4.0 milliliters of mercury (mmHg) Standard Deviation 12.17	-6.7 milliliters of mercury (mmHg) Standard Deviation 4.16
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 4	-14.0 milliliters of mercury (mmHg) Standard Deviation 10.58	-8.3 milliliters of mercury (mmHg) Standard Deviation 16.17	8.7 milliliters of mercury (mmHg) Standard Deviation 17.67	-26.5 milliliters of mercury (mmHg) Standard Deviation 21.77	-5.7 milliliters of mercury (mmHg) Standard Deviation 12.06	-11.0 milliliters of mercury (mmHg) Standard Deviation 19.97
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Diastolic BP, Day 8/discharge	-12.0 milliliters of mercury (mmHg) Standard Deviation 2.83	-4.0 milliliters of mercury (mmHg) Standard Deviation 11.31	12.0 milliliters of mercury (mmHg) Standard Deviation 19.67	-24.2 milliliters of mercury (mmHg) Standard Deviation 36.31	2.5 milliliters of mercury (mmHg) Standard Deviation 7.78	-6.0 milliliters of mercury (mmHg) Standard Deviation 6.24
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 1 (5 min)	-6.3 milliliters of mercury (mmHg) Standard Deviation 13.28	27.7 milliliters of mercury (mmHg) Standard Deviation 27.65	-4.3 milliliters of mercury (mmHg) Standard Deviation 8.14	-10.2 milliliters of mercury (mmHg) Standard Deviation 12.56	11.0 milliliters of mercury (mmHg) Standard Deviation 12.12	9.7 milliliters of mercury (mmHg) Standard Deviation 7.23
Change From Baseline for Supine Systolic and Diastolic Blood Pressure Supine Systolic BP, Day 1 (45 min)	-13.3 milliliters of mercury (mmHg) Standard Deviation 12.01	15.0 milliliters of mercury (mmHg) Standard Deviation 36.76	-5.3 milliliters of mercury (mmHg) Standard Deviation 38.28	-26.7 milliliters of mercury (mmHg) Standard Deviation 27.53	12.0 milliliters of mercury (mmHg) Standard Deviation 20.95	-6.7 milliliters of mercury (mmHg) Standard Deviation 29.54

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified time point.

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.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Change From Baseline for Supine Pulse Rate Day 1 (45 min)	8.0 beats per minute (bpm) Standard Deviation 20.07	-1.3 beats per minute (bpm) Standard Deviation 23.18	-2.7 beats per minute (bpm) Standard Deviation 7.51	-0.2 beats per minute (bpm) Standard Deviation 5.98	-13.3 beats per minute (bpm) Standard Deviation 10.07	2.7 beats per minute (bpm) Standard Deviation 14.19
Change From Baseline for Supine Pulse Rate Day 2	-13.0 beats per minute (bpm) Standard Deviation 19.97	-21.0 beats per minute (bpm) Standard Deviation 18.73	5.7 beats per minute (bpm) Standard Deviation 1.15	-2.7 beats per minute (bpm) Standard Deviation 5.89	-11.0 beats per minute (bpm) Standard Deviation 16.37	-3.3 beats per minute (bpm) Standard Deviation 21.50
Change From Baseline for Supine Pulse Rate Day 1 (5 min)	-0.7 beats per minute (bpm) Standard Deviation 5.69	1.3 beats per minute (bpm) Standard Deviation 4.16	1.7 beats per minute (bpm) Standard Deviation 1.53	0.0 beats per minute (bpm) Standard Deviation 2.45	-17.3 beats per minute (bpm) Standard Deviation 17.01	2.7 beats per minute (bpm) Standard Deviation 4.62
Change From Baseline for Supine Pulse Rate Day 3	-12.3 beats per minute (bpm) Standard Deviation 22.28	-13.0 beats per minute (bpm) Standard Deviation 7.94	1.0 beats per minute (bpm) Standard Deviation 12.00	9.2 beats per minute (bpm) Standard Deviation 13.53	-14.3 beats per minute (bpm) Standard Deviation 17.21	3.0 beats per minute (bpm) Standard Deviation 25.94
Change From Baseline for Supine Pulse Rate Day 4	-13.7 beats per minute (bpm) Standard Deviation 31.53	-21.0 beats per minute (bpm) Standard Deviation 12.12	-11.0 beats per minute (bpm) Standard Deviation 9.85	-3.7 beats per minute (bpm) Standard Deviation 10.84	-12.7 beats per minute (bpm) Standard Deviation 30.17	7.3 beats per minute (bpm) Standard Deviation 18.77
Change From Baseline for Supine Pulse Rate Day 8/discharge	-16.5 beats per minute (bpm) Standard Deviation 36.06	-18.0 beats per minute (bpm) Standard Deviation 7.07	-1.7 beats per minute (bpm) Standard Deviation 4.16	6.2 beats per minute (bpm) Standard Deviation 8.04	-34.0 beats per minute (bpm) Standard Deviation 0.00	2.0 beats per minute (bpm) Standard Deviation 5.57

PRIMARY outcome

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

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified category.

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

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 2 · No significant change	3 Participants	3 Participants	3 Participants	6 Participants	3 Participants	3 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 2 · Less abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 2 · More abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 4 · Less abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 4 · No significant change	3 Participants	3 Participants	3 Participants	6 Participants	2 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 4 · More abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 8/discharge · Less abnormal	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 8/discharge · No significant change	2 Participants	2 Participants	3 Participants	4 Participants	2 Participants	2 Participants
Number of Participants With Electrocardiogram (ECG) Qualitative Results Day 8/discharge · More abnormal	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (pre-dose), Day 2

Population: All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.

Maximum changes from baseline were calculated for activated partial thromboplastin time (aPTT) after dosing with PF-05230907 through Day 2.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT)	-8.53 seconds (sec) Standard Deviation 3.250	-12.17 seconds (sec) Standard Deviation 1.060	-8.47 seconds (sec) Standard Deviation 1.790	-8.76 seconds (sec) Standard Deviation 4.859	-5.00 seconds (sec) Standard Deviation 5.522	-12.03 seconds (sec) Standard Deviation 4.574

SECONDARY outcome

Timeframe: Baseline (pre-dose), Day 2

Population: All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.

Maximum changes from baseline were calculated for prothrombin fragment 1+2 (PF1+2) after dosing with PF-05230907 through Day 2.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2)	-163.7 picomoles per liter (pmol/L) Standard Deviation 390.08	2823.7 picomoles per liter (pmol/L) Standard Deviation 137.25	1286.0 picomoles per liter (pmol/L) Standard Deviation 1331.09	492.6 picomoles per liter (pmol/L) Standard Deviation 1445.60	1773.7 picomoles per liter (pmol/L) Standard Deviation 1472.95	354.3 picomoles per liter (pmol/L) Standard Deviation 501.75

SECONDARY outcome

Timeframe: Day 1 up to follow-up visit (Day 43 and/or Day 91)

Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.

Participants with anti-drug antibody (ADA) production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). ADA positive: titer value \>=1.88.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Anti-Drug Antibody (ADA) Production	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to follow-up visit (Day 43 and/or Day 91)

Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.

ADA positive samples were planned to be further characterized for neutralizing antibody (NAb). Participants with NAb production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). As all ADA samples were negative (titer value \<1.88), NAb analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose), Day 43, Day 91

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified category.

Depletion of coagulation factor X was defined as \>50% reduction relative to baseline (pre-dose).

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Depletion of Coagulation Factor X Day 43	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Depletion of Coagulation Factor X Day 91	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (pre-dose), 24 hours

Population: All participants who received the treatment of PF-05230907.

Change from baseline in intracerebral hemorrhage (ICH) volume was calculated at 24 hours.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours	-0.297 centimeter (cm)^3 Standard Deviation 0.3761	0.410 centimeter (cm)^3 Standard Deviation 2.1554	12.137 centimeter (cm)^3 Standard Deviation 10.9207	1.190 centimeter (cm)^3 Standard Deviation 2.1099	1.130 centimeter (cm)^3 Standard Deviation 1.7385	0.097 centimeter (cm)^3 Standard Deviation 1.8781

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 pre-dose, 5 and 45 minutes post-dose

Population: All treated participants who had at least 1 measurement of PF-05230907 concentration. "Number Analyzed" represents the number of participants evaluable for each specified category.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
PF-05230907 Concentration in Plasma Pre-dose	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and standard deviation (SD) were not available as none of the analyzed participants had plasma PF-05230907 concentration above the lower limit of quantification (LLOQ). The LLOQ was 1.95 ng/mL.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and SD were not available as none of the analyzed participants had plasma PF-05230907 concentration above the LLOQ. The LLOQ was 1.95 ng/mL.	17.46 nanogram per milliliter (ng/mL) Standard Deviation 28.121	2.382 nanogram per milliliter (ng/mL) Standard Deviation 3.4180	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and SD were not available as none of the analyzed participants had plasma PF-05230907 concentration above the LLOQ. The LLOQ was 1.95 ng/mL.	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and SD were not available as none of the analyzed participants had plasma PF-05230907 concentration above the LLOQ. The LLOQ was 1.95 ng/mL.
PF-05230907 Concentration in Plasma 5 minutes post-dose	11.90 nanogram per milliliter (ng/mL) Standard Deviation 13.359	—	34.63 nanogram per milliliter (ng/mL) Standard Deviation 30.731	39.82 nanogram per milliliter (ng/mL) Standard Deviation 28.393	35.60 nanogram per milliliter (ng/mL) Standard Deviation 21.072	41.17 nanogram per milliliter (ng/mL) Standard Deviation 23.756
PF-05230907 Concentration in Plasma 45 minutes post-dose	1.377 nanogram per milliliter (ng/mL) Standard Deviation 1.1935	2.460 nanogram per milliliter (ng/mL) Standard Deviation 0.32527	17.21 nanogram per milliliter (ng/mL) Standard Deviation 23.815	6.938 nanogram per milliliter (ng/mL) Standard Deviation 1.6070	2.490 nanogram per milliliter (ng/mL) Standard Deviation NA SD was not available as only 1 participant was analyzed.	4.657 nanogram per milliliter (ng/mL) Standard Deviation 1.6342

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 43

Population: All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest. "Number Analyzed" represents the number of participants evaluable for each specified category.

Participants with anti-Chinese hamster ovary (CHO) antibody production were those with positive results. Positive: titer value \>=2.00.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production Day 1	0 Participants	1 Participants	2 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production Day 43	0 Participants	1 Participants	2 Participants	3 Participants	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1, Day 43

Participants with anti-paired basic amino acid cleaving enzyme (PACE) antibody production were those with positive results. Positive: titer value \>=2.00.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production Day 43	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Day 1, Day 2, Day 4, Day 43, and Day 91

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified category.

The National Institute of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Day 4	5.7 units on a scale Standard Deviation 8.08	12.7 units on a scale Standard Deviation 8.14	16.0 units on a scale Standard Deviation 10.82	9.8 units on a scale Standard Deviation 5.98	13.5 units on a scale Standard Deviation 2.12	14.7 units on a scale Standard Deviation 6.03
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Screening	11.7 units on a scale Standard Deviation 7.37	10.7 units on a scale Standard Deviation 8.62	15.3 units on a scale Standard Deviation 10.60	15.7 units on a scale Standard Deviation 4.68	17.0 units on a scale Standard Deviation 2.65	13.7 units on a scale Standard Deviation 7.51
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Day 1	11.3 units on a scale Standard Deviation 6.81	14.0 units on a scale Standard Deviation 6.24	15.3 units on a scale Standard Deviation 10.60	15.2 units on a scale Standard Deviation 6.37	16.0 units on a scale Standard Deviation 2.83	13.7 units on a scale Standard Deviation 7.51
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Day 2	10.0 units on a scale Standard Deviation 12.73	16.3 units on a scale Standard Deviation 6.51	16.0 units on a scale Standard Deviation 10.82	12.3 units on a scale Standard Deviation 5.43	16.0 units on a scale Standard Deviation 4.24	14.3 units on a scale Standard Deviation 5.86
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Day 43	1.0 units on a scale Standard Deviation 1.00	8.3 units on a scale Standard Deviation 8.39	4.5 units on a scale Standard Deviation 6.36	4.4 units on a scale Standard Deviation 5.59	15.5 units on a scale Standard Deviation 4.95	5.0 units on a scale Standard Deviation 1.41
Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS) Day 91	0.7 units on a scale Standard Deviation 0.58	1.5 units on a scale Standard Deviation 0.71	3.5 units on a scale Standard Deviation 3.54	5.2 units on a scale Standard Deviation 5.07	13.5 units on a scale Standard Deviation 7.78	2.0 units on a scale Standard Deviation 2.83

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 up to Day 91

Population: All participants who received the treatment of PF-05230907. "Number Analyzed" represents the number of participants evaluable for each specified category.

Maximum duration for 4 types of hospital or health care unit: Intensive Care Unit (ICU), general ward, rehabilitation center, and other hospital units. This was an exploratory endpoint to evaluate information for designing future studies, which were no longer planned.

Outcome measures

Outcome measures
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 Participants PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 Participants PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 Participants PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 Participants PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 Participants PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 Participants PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Health Resource Utilization Surrogate Measures - Maximum Duration ICU	2 days NA as only 1 participant had data.	2 days NA as only 1 participant had data.	1 days NA as only 1 participant had data.	30 days Interval 1.0 to 59.0	17.5 days Interval 4.0 to 31.0	1 days NA as only 1 participant had data.
Health Resource Utilization Surrogate Measures - Maximum Duration General ward	1 days NA as only 1 participant had data.	5 days Interval 1.0 to 7.0	16.5 days Interval 16.0 to 17.0	7 days Interval 6.0 to 7.0	31.5 days Interval 0.0 to 63.0	26 days Interval 5.0 to 42.0
Health Resource Utilization Surrogate Measures - Maximum Duration Rehabilitation center	75 days NA as only 1 participant had data.	75 days Interval 61.0 to 79.0	40.5 days Interval 22.0 to 59.0	30.5 days Interval 26.0 to 43.0	79 days NA as only 1 participant had data.	20 days Interval 14.0 to 26.0
Health Resource Utilization Surrogate Measures - Maximum Duration Other hospital unit	4 days Interval 4.0 to 4.0	3 days Interval 2.0 to 4.0	7 days NA as only 1 participant had data.	24 days Interval 17.0 to 31.0	3.5 days Interval 1.0 to 6.0	—

Adverse Events

PF-05230907 5 Microgram Per Kilogram (mcg/kg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PF-05230907 8 mcg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

PF-05230907 12 mcg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

PF-05230907 19 mcg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

PF-05230907 24 mcg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

PF-05230907 30 mcg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 participants at risk PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 participants at risk PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 participants at risk PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 participants at risk PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 participants at risk PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 participants at risk PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Infections and infestations Pneumonia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Brain oedema	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Stroke in evolution	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Vascular disorders Thrombophlebitis	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.

Other adverse events

Other adverse events
Measure	PF-05230907 5 Microgram Per Kilogram (mcg/kg) n=3 participants at risk PF-05230907 5 mcg/kg was administered as a single intravenous (IV) bolus on Day 1.	PF-05230907 8 mcg/kg n=3 participants at risk PF-05230907 8 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 12 mcg/kg n=3 participants at risk PF-05230907 12 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 19 mcg/kg n=6 participants at risk PF-05230907 19 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 24 mcg/kg n=3 participants at risk PF-05230907 24 mcg/kg was administered as a single IV bolus on Day 1.	PF-05230907 30 mcg/kg n=3 participants at risk PF-05230907 30 mcg/kg was administered as a single IV bolus on Day 1.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Cardiac disorders Atrial flutter	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Gastrointestinal disorders Constipation	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	100.0% 3/3 • Number of events 3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Gastrointestinal disorders Nausea	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	66.7% 2/3 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Gastrointestinal disorders Vomiting	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
General disorders Chest pain	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
General disorders Injection site phlebitis	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
General disorders Oedema peripheral	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
General disorders Pain	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Infections and infestations Urinary tract infection	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Investigations Bacterial test positive	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Investigations Blood triglycerides increased	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Investigations Fibrin D dimer increased	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Investigations Troponin I increased	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 2/6 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Metabolism and nutrition disorders Hypoglycaemia	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Cerebral ischaemia	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Dizziness	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 2/6 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Seizure	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Somnolence	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Nervous system disorders Syncope	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Psychiatric disorders Agitation	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Renal and urinary disorders Urinary retention	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	16.7% 1/6 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Surgical and medical procedures Pain management	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/6 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.
Vascular disorders Hypertension	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	0.00% 0/3 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	66.7% 4/6 • Number of events 5 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	66.7% 2/3 • Number of events 2 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.	33.3% 1/3 • Number of events 1 • For each participant, Adverse Events (AEs) were collected up to Day 43/follow-up visit. All-Cause Mortality table presents all deaths up to 3.4 months. An AE may be categorized as serious in 1 participant and as non-serious in another participant; 1 participant may have experienced both a serious and non-serious AE.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER