Trial Outcomes & Findings for Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin (NCT NCT00742859)
NCT ID: NCT00742859
Last Updated: 2023-08-07
Results Overview
The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
508 participants
Primary outcome timeframe
A maximum of 1 year
Results posted on
2023-08-07
Participant Flow
Between 31 October 2008 and 05 November 2009, 508 patients were enrolled by 35 study centers in 3 countries (USA, Canada, Germany). Patients were randomized to 1 of 4 treatment groups (1:1:1:1 allocation). The study was open-label for warfarin, while the 3 daily doses of betrixaban (40, 60, or 80 mg) were double-blinded.
561 patients were screened for study participation. Of these patients, 508 were randomized, all of whom received at least 1 dose of study drug.
Participant milestones
| Measure |
Betrixaban 40 mg
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
127
|
127
|
|
Overall Study
COMPLETED
|
116
|
115
|
116
|
119
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
11
|
8
|
Reasons for withdrawal
| Measure |
Betrixaban 40 mg
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
4
|
1
|
|
Overall Study
Endpoint
|
0
|
1
|
1
|
2
|
|
Overall Study
Amendment 2 patient off study drug >4wks
|
0
|
1
|
1
|
0
|
|
Overall Study
Sponsor req visit schedule noncompliance
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor request patient out of town
|
0
|
0
|
1
|
1
|
|
Overall Study
Site error
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Baseline characteristics by cohort
| Measure |
Betrixaban 40 mg
n=127 Participants
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
n=127 Participants
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
n=127 Participants
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
n=127 Participants
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 8.35 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 8.75 • n=4 Participants
|
73.0 years
STANDARD_DEVIATION 8.32 • n=21 Participants
|
|
Age, Customized
<75 years
|
64 Count of Participants
n=5 Participants
|
61 Count of Participants
n=7 Participants
|
76 Count of Participants
n=5 Participants
|
67 Count of Participants
n=4 Participants
|
268 Count of Participants
n=21 Participants
|
|
Age, Customized
>=75 years
|
63 Count of Participants
n=5 Participants
|
66 Count of Participants
n=7 Participants
|
51 Count of Participants
n=5 Participants
|
60 Count of Participants
n=4 Participants
|
240 Count of Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
338 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: A maximum of 1 yearPopulation: All randomized patients who took at least 1 dose of study medication after randomization.
The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.
Outcome measures
| Measure |
Betrixaban 40 mg
n=127 Participants
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
n=127 Participants
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
n=127 Participants
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
n=127 Participants
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode
|
2.02 Number of Patients per 100 Patient years
Interval 0.05 to 11.3
|
10.1 Number of Patients per 100 Patient years
Interval 3.28 to 23.6
|
10.5 Number of Patients per 100 Patient years
Interval 3.41 to 24.5
|
14.6 Number of Patients per 100 Patient years
Interval 5.85 to 30.0
|
SECONDARY outcome
Timeframe: A maximum of 1 yearPopulation: All randomized patients who took at least 1 dose of study medication after randomization.
The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.
Outcome measures
| Measure |
Betrixaban 40 mg
n=127 Participants
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
n=127 Participants
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
n=127 Participants
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
n=127 Participants
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)
|
50.5 Number of Patients per 100 Patient years
Interval 31.7 to 76.5
|
77.9 Number of Patients per 100 Patient years
Interval 53.3 to 110.0
|
56.0 Number of Patients per 100 Patient years
Interval 35.9 to 83.4
|
103 Number of Patients per 100 Patient years
Interval 73.6 to 140.0
|
Adverse Events
Betrixaban 40 mg
Serious events: 12 serious events
Other events: 61 other events
Deaths: 61 deaths
Betrixaban 60 mg
Serious events: 12 serious events
Other events: 68 other events
Deaths: 68 deaths
Betrixaban 80 mg
Serious events: 11 serious events
Other events: 53 other events
Deaths: 53 deaths
Warfarin
Serious events: 12 serious events
Other events: 50 other events
Deaths: 50 deaths
Serious adverse events
| Measure |
Betrixaban 40 mg
n=127 participants at risk
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
n=127 participants at risk
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
n=127 participants at risk
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
n=127 participants at risk
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.79%
1/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Infections and infestations
Cellulitis
|
0.79%
1/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Infections and infestations
Cystitis
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac Neoplasm Unspecified
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Recurrent
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.79%
1/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Nervous system disorders
Presyncope
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Nervous system disorders
Syncope
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
Abdominal Hernia Obstructive
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Ligament Disorder
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Vascular disorders
Arterial Stenosis
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
General disorders
Chest Pain
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Investigations
Internaional Normalised Ratio Increased
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
Other adverse events
| Measure |
Betrixaban 40 mg
n=127 participants at risk
Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 60 mg
n=127 participants at risk
Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months
|
Betrixaban 80 mg
n=127 participants at risk
Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months
|
Warfarin
n=127 participants at risk
Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months
|
|---|---|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
0.79%
1/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
NAUSEA
|
1.6%
2/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
11.0%
14/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.1%
4/127 • Maximum of 1 year
|
7.9%
10/127 • Maximum of 1 year
|
7.1%
9/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Nervous system disorders
HEADACHE
|
3.9%
5/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
7.1%
9/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
General disorders
OEDEMA PERIPHERAL
|
6.3%
8/127 • Maximum of 1 year
|
7.9%
10/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
8.7%
11/127 • Maximum of 1 year
|
|
Nervous system disorders
DIZZINESS
|
9.4%
12/127 • Maximum of 1 year
|
7.1%
9/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.9%
5/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
|
Psychiatric disorders
INSOMNIA
|
1.6%
2/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.1%
4/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
|
General disorders
FATIGUE
|
5.5%
7/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
|
Infections and infestations
BRONCHITIS
|
0.79%
1/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.9%
5/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Infections and infestations
INFLUENZA
|
1.6%
2/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.5%
7/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.1%
9/127 • Maximum of 1 year
|
6.3%
8/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.4%
3/127 • Maximum of 1 year
|
6.3%
8/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.4%
3/127 • Maximum of 1 year
|
4.7%
6/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.9%
5/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
7.9%
10/127 • Maximum of 1 year
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.1%
4/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.6%
2/127 • Maximum of 1 year
|
3.9%
5/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
|
General disorders
CHEST PAIN
|
3.9%
5/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.4%
3/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
1.6%
2/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
|
Vascular disorders
HYPERTENSION
|
2.4%
3/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.79%
1/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
0.79%
1/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.79%
1/127 • Maximum of 1 year
|
3.1%
4/127 • Maximum of 1 year
|
0.00%
0/127 • Maximum of 1 year
|
2.4%
3/127 • Maximum of 1 year
|
Additional Information
Head of Clinical Development
Portola Pharmaceuticals, Inc.
Phone: 650-246-7000
Results disclosure agreements
- Principal investigator is a sponsor employee Due to multiple studies, centers and countries this may vary.
- Publication restrictions are in place
Restriction type: OTHER