Trial Outcomes & Findings for AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients (NCT NCT01780987)
NCT ID: NCT01780987
Last Updated: 2016-06-23
Results Overview
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2016-06-23
Participant Flow
Participant milestones
| Measure |
Apixaban
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Apixaban
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Request of Changing Hospital
|
0
|
1
|
|
Overall Study
Changing Residence
|
1
|
0
|
|
Overall Study
Not Receiving any Study Medication
|
0
|
1
|
Baseline Characteristics
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Baseline characteristics by cohort
| Measure |
Apixaban
n=40 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=40 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 17.72 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 15.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE)
DVT
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE)
PE
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: The safety analysis set (SAS) consisted of all treated participants.
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=39 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
|
3 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.
VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late.
Outcome measures
| Measure |
Apixaban
n=38 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=40 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.
Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.
Outcome measures
| Measure |
Apixaban
n=22 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=23 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
CUS - Week 2 (n=22, n=22)
|
1 participants
|
2 participants
|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
CTV - Week 12 (n=20, n=21)
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
CUS - Week 12 (n=21, n=22)
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
CUS - Week 24 (n=20, n=22)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.
Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.
Outcome measures
| Measure |
Apixaban
n=18 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=17 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
CTPA - Week 2 (n=18, n=17)
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
CTPA - Week 12 (n=18, n=16)
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
CTPA - Week 24 (n=16, n=15)
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The safety analysis set (SAS) consisted of all treated participants.
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=39 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The safety analysis set (SAS) consisted of all treated participants.
All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.
Outcome measures
| Measure |
Apixaban
n=40 Participants
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=39 Participants
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
|
7 participants
|
17 participants
|
Adverse Events
Apixaban
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Unfractionated Heparin (UFH)/Warfarin
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apixaban
n=40 participants at risk
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=39 participants at risk
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Parkinsonism
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Apixaban
n=40 participants at risk
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
|
Unfractionated Heparin (UFH)/Warfarin
n=39 participants at risk
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
5.0%
2/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
5/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.5%
8/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
10.0%
4/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
5/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
5.0%
2/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
5/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
4/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
5.0%
2/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
10.0%
4/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
1/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.5%
3/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.8%
5/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.3%
4/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
1/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haematoma
|
5.0%
2/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.1%
2/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/40
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.7%
3/39
The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
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