Trial Outcomes & Findings for Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis) (NCT NCT00443053)

Last Updated: 2017-03-06

Results Overview

VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3002 participants

Primary outcome timeframe

Baseline to Day 47

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo Matching placebo
Overall Study STARTED	1502	1500
Overall Study COMPLETED	1481	1467
Overall Study NOT COMPLETED	21	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Fondaparinux 2.5 mg Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo Matching placebo
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	9	18
Overall Study Lost to Follow-up	4	5
Overall Study Did Not Meet Eligibility Criteria	1	0
Overall Study Noncompliance	2	1
Overall Study Other	3	4
Overall Study Physician Decision	0	4

Baseline Characteristics

Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fondaparinux 2.5 mg n=1502 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1500 Participants Matching placebo	Total n=3002 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 13.29 • n=99 Participants	56.9 years STANDARD_DEVIATION 13.56 • n=107 Participants	57.0 years STANDARD_DEVIATION 13.43 • n=206 Participants
Sex: Female, Male Female	974 Participants n=99 Participants	944 Participants n=107 Participants	1918 Participants n=206 Participants
Sex: Female, Male Male	528 Participants n=99 Participants	556 Participants n=107 Participants	1084 Participants n=206 Participants
Race/Ethnicity, Customized White, European Heritage	1485 participants n=99 Participants	1492 participants n=107 Participants	2977 participants n=206 Participants
Race/Ethnicity, Customized Arabic/North African Heritage	15 participants n=99 Participants	4 participants n=107 Participants	19 participants n=206 Participants
Race/Ethnicity, Customized African American Heritage	0 participants n=99 Participants	2 participants n=107 Participants	2 participants n=206 Participants
Race/Ethnicity, Customized Asian/South Asian Heritage	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Mixed Race	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Missing	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to Day 47

Population: Intent-to-Treat (ITT) Population: all randomized participants

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1502 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1500 Participants Matching placebo
Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47	13 participants	88 participants

SECONDARY outcome

Timeframe: Baseline to Day 77

Population: ITT Population

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1502 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1500 Participants Matching placebo
Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77	18 participants	94 participants

SECONDARY outcome

Timeframe: Days 47 and 77

Population: ITT Population

VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within \<=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length.

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1502 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1500 Participants Matching placebo
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Participants with at least one event, D 47	13 participants	88 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Death, D 47	2 participants	1 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic PE, D 47	0 participants	5 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic DVT, D 47	3 participants	18 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic recurrence of SVT, D 47	5 participants	24 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic extension of SVT, D 47	4 participants	51 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Participants with at least one event, D 77	18 participants	94 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Death, D 77	2 participants	1 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic PE, D 77	0 participants	6 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic DVT, D 77	4 participants	19 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic recurrence of SVT, D 77	8 participants	26 participants
Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77 Symptomatic extension of SVT, D 77	5 participants	54 participants

SECONDARY outcome

Timeframe: Days 47 and 77

Population: ITT Population

The number of participants requiring surgery was measured.

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1502 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1500 Participants Matching placebo
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77 Day 47	11 participants	57 participants
Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77 Day 77	15 participants	61 participants

SECONDARY outcome

Timeframe: Days 47 (or last dose plus 4 days) and 77

Population: As-Treated Population: randomized participants who received at least one dose of study treatment, as actually received

Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin \>=20 g/L (1.24 mmol/L); (3) led to a transfusion of \>=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1499 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1488 Participants Matching placebo
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 Major bleeding events, Day 47	1 events	1 events
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 Deaths, Day 47	2 events	1 events
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 Major bleeding events, Day 77	1 events	1 events
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77 Deaths, Day 77	2 events	1 events

SECONDARY outcome

Timeframe: Days 47 (or last dose plus 4 days) and 77

Population: As-Treated Population

Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1499 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1488 Participants Matching placebo
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77 Day 47	5 events	8 events
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77 Day 77	6 events	9 events

SECONDARY outcome

Timeframe: Days 47 (or last dose plus 4 days) and 77

Population: As-Treated Population

The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated "On-Treatment," defined as from randomization up to the last injection +4 days.

Outcome measures

Outcome measures
Measure	Fondaparinux 2.5 mg n=1499 Participants Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1488 Participants Matching placebo
Number of Any Adjudicated Bleeding Events at Days 47 and 77 Day 47	15 events	14 events
Number of Any Adjudicated Bleeding Events at Days 47 and 77 Day 77	16 events	15 events

Adverse Events

Fondaparinux 2.5 mg

Serious events: 10 serious events

Other events: 95 other events

Deaths: 0 deaths

Placebo

Serious events: 16 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fondaparinux 2.5 mg n=1499 participants at risk Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1488 participants at risk Matching placebo
Nervous system disorders Headache	2.3% 34/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	2.1% 31/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Skin and subcutaneous tissue disorders Injection site hematoma	1.8% 27/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	1.1% 17/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Hypertension	1.3% 20/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	1.0% 15/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
General disorders Asthenia	0.93% 14/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	1.1% 16/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.

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 2.5 mg n=1499 participants at risk Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days	Placebo n=1488 participants at risk Matching placebo
Cardiac disorders Angina pectoris	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Cardiac disorders Atrial fibrillation	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Cardiac disorders Cardiac failure acute	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Cardiac disorders Coronary artery disease	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.13% 2/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Cardiac disorders Myocardial infarction	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Cardiac disorders Right ventricular failure	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Hepatobiliary disorders Billiary colic	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Infections and infestations Erysipelas	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Infections and infestations Haematoma infection	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Infections and infestations Peritonsillar abscess	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Infections and infestations Prostatic abscess	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Infections and infestations Staphylococcal infection	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Injury, poisoning and procedural complications Fall	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Nervous system disorders Cerebrovascular accident	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Nervous system disorders Vertebrobasilar insufficiency	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Renal and urinary disorders Renal colic	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Renal and urinary disorders Renal cyst	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Renal and urinary disorders Urethral obstruction	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Skin and subcutaneous tissue disorders Dermatitis	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Circulatory collapse	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Hypertensive crisis	0.00% 0/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.07% 1/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Jugular vein thrombosis	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Subclavian vein thrombosis	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.
Vascular disorders Vena cave thrombosis	0.07% 1/1499 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.	0.00% 0/1488 Serious adverse events (SAEs) and adverse events (AEs) were collected in the As-Treated Population, defined as randomized participants who received at least one dose of study treatment, as actually received.