Trial Outcomes & Findings for Cancer Venous Thromboembolism (VTE) (NCT NCT02073682)
NCT ID: NCT02073682
Last Updated: 2019-03-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1046 participants
Primary outcome timeframe
12 months
Results posted on
2019-03-06
Participant Flow
1050 participants were randomized from 114 sites in Western Europe (31), Central Europe (11), South Europe (36), Australia/New Zealand (13) and North America (23)
Of 1050 participants randomized, 1046 took study drug and were included in the modified Intent to Treat (mITT) and Safety Analysis Sets
Participant milestones
| Measure |
Edoxaban Group
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
Participants received dalteparin daily
|
|---|---|---|
|
Overall Study
STARTED
|
522
|
524
|
|
Overall Study
COMPLETED
|
200
|
154
|
|
Overall Study
NOT COMPLETED
|
322
|
370
|
Reasons for withdrawal
| Measure |
Edoxaban Group
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
Participants received dalteparin daily
|
|---|---|---|
|
Overall Study
Low Creatinine Clearance
|
1
|
2
|
|
Overall Study
Death
|
86
|
100
|
|
Overall Study
Cancer Cured
|
10
|
15
|
|
Overall Study
ID: Patient Noncompliance
|
1
|
2
|
|
Overall Study
ID: Palliative Treatment Only
|
10
|
7
|
|
Overall Study
Prohibited Concomitant Medication Use
|
0
|
1
|
|
Overall Study
Platelet Count <50,000/mL
|
1
|
2
|
|
Overall Study
Surgery/Medical Procedure
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Start of New Chemotherapy Regimen
|
6
|
3
|
|
Overall Study
Cancer Progression
|
53
|
33
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
79
|
62
|
|
Overall Study
No reason provided
|
11
|
9
|
|
Overall Study
PD: Inconvenience of Dosing
|
21
|
78
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
ID: Benefit/Risk Judgment
|
32
|
46
|
Baseline Characteristics
The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
Baseline characteristics by cohort
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
Total
n=1046 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=522 Participants
|
65 years
n=524 Participants
|
65 years
n=1046 Participants
|
|
Age, Customized
18-64 Years
|
246 Participants
n=522 Participants
|
261 Participants
n=524 Participants
|
507 Participants
n=1046 Participants
|
|
Age, Customized
65-84 Years
|
267 Participants
n=522 Participants
|
254 Participants
n=524 Participants
|
521 Participants
n=1046 Participants
|
|
Age, Customized
85 years and over
|
9 Participants
n=522 Participants
|
9 Participants
n=524 Participants
|
18 Participants
n=1046 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=522 Participants
|
261 Participants
n=524 Participants
|
506 Participants
n=1046 Participants
|
|
Sex: Female, Male
Male
|
277 Participants
n=522 Participants
|
263 Participants
n=524 Participants
|
540 Participants
n=1046 Participants
|
|
Race/Ethnicity, Customized
White
|
453 Participants
n=509 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
427 Participants
n=506 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
880 Participants
n=1015 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=509 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
21 Participants
n=506 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
38 Participants
n=1015 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=509 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
13 Participants
n=506 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
19 Participants
n=1015 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=509 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
1 Participants
n=506 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
1 Participants
n=1015 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
|
Race/Ethnicity, Customized
Other
|
33 Participants
n=509 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
44 Participants
n=506 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
77 Participants
n=1015 Participants • The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.
|
|
Region of Enrollment
Netherlands
|
61 participants
n=522 Participants
|
57 participants
n=524 Participants
|
118 participants
n=1046 Participants
|
|
Region of Enrollment
Belgium
|
22 participants
n=522 Participants
|
19 participants
n=524 Participants
|
41 participants
n=1046 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=522 Participants
|
16 participants
n=524 Participants
|
33 participants
n=1046 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=522 Participants
|
103 participants
n=524 Participants
|
207 participants
n=1046 Participants
|
|
Region of Enrollment
Italy
|
45 participants
n=522 Participants
|
45 participants
n=524 Participants
|
90 participants
n=1046 Participants
|
|
Region of Enrollment
France
|
58 participants
n=522 Participants
|
64 participants
n=524 Participants
|
122 participants
n=1046 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=522 Participants
|
15 participants
n=524 Participants
|
28 participants
n=1046 Participants
|
|
Region of Enrollment
Germany
|
30 participants
n=522 Participants
|
29 participants
n=524 Participants
|
59 participants
n=1046 Participants
|
|
Region of Enrollment
Czechia
|
11 participants
n=522 Participants
|
10 participants
n=524 Participants
|
21 participants
n=1046 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=522 Participants
|
35 participants
n=524 Participants
|
70 participants
n=1046 Participants
|
|
Region of Enrollment
Australia
|
16 participants
n=522 Participants
|
16 participants
n=524 Participants
|
32 participants
n=1046 Participants
|
|
Region of Enrollment
New Zealand
|
12 participants
n=522 Participants
|
13 participants
n=524 Participants
|
25 participants
n=1046 Participants
|
|
Region of Enrollment
Canada
|
98 participants
n=522 Participants
|
102 participants
n=524 Participants
|
200 participants
n=1046 Participants
|
|
Type of Cancer
Solid Tumor
|
465 Participants
n=522 Participants
|
467 Participants
n=524 Participants
|
932 Participants
n=1046 Participants
|
|
Type of Cancer
Haematological Malignancy
|
56 Participants
n=522 Participants
|
55 Participants
n=524 Participants
|
111 Participants
n=1046 Participants
|
|
Type of Cancer
Solid Tumor and Haematological Malignancy
|
1 Participants
n=522 Participants
|
2 Participants
n=524 Participants
|
3 Participants
n=1046 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: modified Intent to Treat (mITT), equating to the Safety Analysis Set
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
|
67 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Safety analysis set
The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Adjudicated Major Bleeding Events While on Treatment
|
32 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT (Safety Analysis Set)
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
|
41 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT (Safety Analysis Set)
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
|
19 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT (Safety Analysis Set)
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT (Safety Analysis Set)
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With VTE-Related Death
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: mITT (Safety Analysis Set)
Outcome measures
| Measure |
Edoxaban Group
n=522 Participants
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 Participants
Participants received dalteparin daily
|
|---|---|---|
|
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
|
235 Participants
|
228 Participants
|
Adverse Events
Edoxaban Group
Serious events: 276 serious events
Other events: 75 other events
Deaths: 206 deaths
Dalteparin Group
Serious events: 251 serious events
Other events: 67 other events
Deaths: 192 deaths
Serious adverse events
| Measure |
Edoxaban Group
n=522 participants at risk
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 participants at risk
Participants received dalteparin daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/522 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac arrest
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Cardiac disorders
Cardiac failure
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiovascular disorder
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Intracardiac mass
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
11/522 • Number of events 12 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/522 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Melaena
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.96%
5/522 • Number of events 5 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.77%
4/522 • Number of events 6 • 12 months
|
0.00%
0/524 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Asthenia
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Chest pain
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 2 • 12 months
|
|
General disorders
Death
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
General disorders
Disease progression
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
General disorders
Euthanasia
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
General disorders
Fatigue
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
General physical health deterioration
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Malaise
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Multi-organ failure
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
General disorders
Oedema peripheral
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
General disorders
Pyrexia
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.00%
0/524 • 12 months
|
|
General disorders
Sudden death
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Abscess limb
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Appendicitis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.38%
2/522 • Number of events 4 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Infection
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Influenza
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Meningococcal sepsis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.1%
16/522 • Number of events 17 • 12 months
|
2.5%
13/524 • Number of events 13 • 12 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Pneumonia viral
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/522 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Sepsis
|
0.77%
4/522 • Number of events 4 • 12 months
|
1.3%
7/524 • Number of events 7 • 12 months
|
|
Infections and infestations
Septic shock
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Staphylococcal sepsis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Infections and infestations
Urosepsis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/522 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Investigations
Creatinine renal clearance decreased
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/522 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Investigations
Transaminases increased
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/522 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Huerthle cell carcinoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.5%
8/522 • Number of events 8 • 12 months
|
1.1%
6/524 • Number of events 6 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
13.2%
69/522 • Number of events 69 • 12 months
|
12.8%
67/524 • Number of events 67 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to rectum
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
4.6%
24/522 • Number of events 24 • 12 months
|
4.0%
21/524 • Number of events 21 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/522 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.77%
4/522 • Number of events 4 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/522 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvar cancer
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Nervous system disorders
Encephalopathy
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.57%
3/524 • Number of events 3 • 12 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Intracranial haematoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
6/522 • Number of events 6 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Nervous system disorders
Leukoencephalopathy
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
Seizure
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Spinal cord haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 2 • 12 months
|
|
Nervous system disorders
Syncope
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Thrombotic stroke
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.38%
2/522 • Number of events 3 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Psychiatric disorders
Confusional state
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/522 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Calculus bladder
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Renal and urinary disorders
Calculus ureteric
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
0.96%
5/522 • Number of events 6 • 12 months
|
0.76%
4/524 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Renal and urinary disorders
Renal infarct
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.57%
3/522 • Number of events 3 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.96%
5/522 • Number of events 6 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.57%
3/524 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.38%
2/522 • Number of events 2 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
8/522 • Number of events 9 • 12 months
|
3.1%
16/524 • Number of events 17 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
7/522 • Number of events 7 • 12 months
|
1.1%
6/524 • Number of events 6 • 12 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/522 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
13/522 • Number of events 13 • 12 months
|
1.5%
8/524 • Number of events 8 • 12 months
|
|
Vascular disorders
Embolism arterial
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Femoral artery embolism
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Haematoma
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.38%
2/524 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypertension
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.19%
1/522 • Number of events 2 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.00%
0/524 • 12 months
|
|
Vascular disorders
Venous thrombosis
|
0.19%
1/522 • Number of events 1 • 12 months
|
0.19%
1/524 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Edoxaban Group
n=522 participants at risk
After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily
|
Dalteparin Group
n=524 participants at risk
Participants received dalteparin daily
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
6.5%
34/522 • Number of events 40 • 12 months
|
7.1%
37/524 • Number of events 45 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.9%
41/522 • Number of events 44 • 12 months
|
5.7%
30/524 • Number of events 42 • 12 months
|
Additional Information
Daiichi Sankyo US Contact for Clinical Trial Results
Daiichi Sankyo, Inc.
Phone: 1-908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60