Trial Outcomes & Findings for The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients (NCT NCT00981409)

Last Updated: 2016-12-16

Results Overview

VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

From Day 1 to Day 90 (±7 days)

Results posted on

2016-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Fondaparinux Sodium (FPX) The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
Overall Study STARTED	30	11
Overall Study COMPLETED	24	10
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fondaparinux Sodium (FPX) The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
Overall Study Adverse Event	4	0
Overall Study Protocol Violation	0	1
Overall Study Prostate Cancer Treatment before Trial	2	0

Baseline Characteristics

The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fondaparinux Sodium (FPX) n=28 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.	Total n=38 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 11.4 • n=5 Participants	62.6 years STANDARD_DEVIATION 14.1 • n=7 Participants	67.0 years STANDARD_DEVIATION 12.2 • n=5 Participants
Gender Female	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Gender Male	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese	28 participants n=5 Participants	10 participants n=7 Participants	38 participants n=5 Participants
Body weight <50 kg	5 kilograms (kg) n=5 Participants	1 kilograms (kg) n=7 Participants	6 kilograms (kg) n=5 Participants
Body weight 50-100 kg	23 kilograms (kg) n=5 Participants	9 kilograms (kg) n=7 Participants	32 kilograms (kg) n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 90 (±7 days)

Population: Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)

VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Outcome measures

Outcome measures
Measure	Fondaparinux Sodium (FPX) n=28 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Day 1 to Day 90 (±7 days)

VTE (pulmonary thromboembolism \[PE\] and/or deep vein thromboembolism \[DVT\]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).

Outcome measures

Outcome measures
Measure	Fondaparinux Sodium (FPX) n=28 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) Symptomatic DVT only	0 percentage of participants	0 percentage of participants
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) (Symptomatic) Non-fatal PE	0 percentage of participants	0 percentage of participants
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) (Symptomatic) Fatal PE	0 percentage of participants	0 percentage of participants
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) Asymptomatic DVT only	0 percentage of participants	0 percentage of participants
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) Asymptomatic PE	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

"Improved," "No change," or "Worse" was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE.

Outcome measures

Outcome measures
Measure	Fondaparinux Sodium (FPX) n=28 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse No change	21.4 percentage of participants	10.0 percentage of participants
The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Improved	78.6 percentage of participants	90.0 percentage of participants
The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Worse	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).

Outcome measures

Outcome measures
Measure	Fondaparinux Sodium (FPX) n=28 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10 Change from baseline, Days 5-10 (+/-1)	0.101 points on a scale Standard Deviation 0.079	0.185 points on a scale Standard Deviation 0.148
Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10 Baseline	0.654 points on a scale Standard Deviation 0.141	0.586 points on a scale Standard Deviation 0.237

SECONDARY outcome

Timeframe: FPX or UFH treatment period (Days 5-10, on average)

Population: Safety population: all participants who received at least one dose of medication (FPX or UFH).

Bleeding events (major bleeding \[clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin \>=2 g/dL, or a transfusion \>=2 units\], minor bleeding \[clinically overt bleeding and not adjudicated as major bleeding\]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).

Outcome measures

Outcome measures
Measure	Fondaparinux Sodium (FPX) n=31 Participants The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 Participants The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
The Percentage of Participants With a Bleeding Event Major bleeding only	0 percentage of participants	0 percentage of participants
The Percentage of Participants With a Bleeding Event Minor bleeding	9.7 percentage of participants	0 percentage of participants
The Percentage of Participants With a Bleeding Event Any bleeding (major and/or minor bleeding)	9.7 percentage of participants	0 percentage of participants

Adverse Events

Fondaparinux Sodium (FPX)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Unfractionated Heparin (UFH)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fondaparinux Sodium (FPX) n=31 participants at risk The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 participants at risk The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
Skin and subcutaneous tissue disorders Drug eruption	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Fondaparinux Sodium (FPX) n=31 participants at risk The dose of FPX was determined based on a participant's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.	Unfractionated Heparin (UFH) n=10 participants at risk The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	12.9% 4/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Gastrointestinal disorders Constipation	9.7% 3/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Infections and infestations Urinary tract infection	9.7% 3/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Musculoskeletal and connective tissue disorders Back pain	6.5% 2/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Investigations Alanine aminotransferase increased	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	20.0% 2/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Investigations Aspartate aminotransferase increased	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	20.0% 2/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	20.0% 2/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Hepatobiliary disorders Liver disorder	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	20.0% 2/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Blister	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Infections and infestations Candidiasis	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Investigations Blood alkaline phosphatase increased	0.00% 0/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	10.0% 1/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Drug eruption	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Ecchymosis	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Erythema	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Skin and subcutaneous tissue disorders Purpura	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Gastrointestinal disorders Abnormal faeces	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Gastrointestinal disorders Peritonitis	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Investigations Occult blood	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
General disorders Chest discomfort	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
General disorders Pyrexia	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Blood and lymphatic system disorders Anaemia	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Reproductive system and breast disorders Genital erosion	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.
Infections and infestations Wound infection	3.2% 1/31 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.	0.00% 0/10 • FPX or UFH treatment period (Days 5-10 days, on average) SAEs and AEs were collected for the Safety Population (all participants who received at least one dose of medication \[FPX or UFH\]). One participant was randomized to UFH, but was incorrectly administered FPX.