Trial Outcomes & Findings for Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer (NCT NCT03045406)
NCT ID: NCT03045406
Last Updated: 2025-06-24
Results Overview
Primary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1170 participants
Primary outcome timeframe
6 months
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
Apixaban
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban: Tablets
|
Dalteparin
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin: Injections
|
|---|---|---|
|
Overall Study
STARTED
|
585
|
585
|
|
Overall Study
COMPLETED
|
399
|
382
|
|
Overall Study
NOT COMPLETED
|
186
|
203
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Apixaban
n=576 Participants
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban: Tablets
|
Dalteparin
n=579 Participants
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin: Injections
|
Total
n=1155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=99 Participants
|
210 Participants
n=107 Participants
|
409 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
377 Participants
n=99 Participants
|
369 Participants
n=107 Participants
|
746 Participants
n=206 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
67.2 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
284 Participants
n=99 Participants
|
303 Participants
n=107 Participants
|
587 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
292 Participants
n=99 Participants
|
276 Participants
n=107 Participants
|
568 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
456 Participants
n=99 Participants
|
469 Participants
n=107 Participants
|
925 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
107 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
64 participants
n=99 Participants
|
74 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
7 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
65 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
204 participants
n=99 Participants
|
193 participants
n=107 Participants
|
397 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=99 Participants
|
18 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
18 participants
n=99 Participants
|
8 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
France
|
102 participants
n=99 Participants
|
90 participants
n=107 Participants
|
192 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
80 participants
n=99 Participants
|
95 participants
n=107 Participants
|
175 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPrimary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)
Outcome measures
| Measure |
Apixaban
n=576 Participants
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban: Tablets
|
Dalteparin
n=579 Participants
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin: Injections
|
|---|---|---|
|
Recurrent Venous Thromboembolism
|
32 Participants
|
46 Participants
|
Adverse Events
Apixaban
Serious events: 255 serious events
Other events: 89 other events
Deaths: 135 deaths
Dalteparin
Serious events: 276 serious events
Other events: 74 other events
Deaths: 153 deaths
Serious adverse events
| Measure |
Apixaban
n=576 participants at risk
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban: Tablets
|
Dalteparin
n=579 participants at risk
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin: Injections
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
6/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.87%
5/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Anaemia Of Malignant Disease
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Anaemia Of Chronic Disease
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Fibrillation
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Arrhythmia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardiac Arrest
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Myocardial Infarction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Thrombosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.4%
8/576 • Number of events 10 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
7/576 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.6%
9/579 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
1.0%
6/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Melaena
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Ascites
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Diarrhoea
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Constipation
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Ileus
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Anal Fistula
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Fistula
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Pseudo-Obstruction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Nausea
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Subileus
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Thrombosis Mesenteric Vessel
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Diaphragmatic Hernia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Duodenal Stenosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Dilatation
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haemorrhagic Ascites
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Condition Aggravated
|
3.8%
22/576 • Number of events 22 • 6 months treatment + 1 month follow-up
No difference in definition
|
3.3%
19/579 • Number of events 24 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Pyrexia
|
2.1%
12/576 • Number of events 13 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.6%
9/579 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Death
|
1.9%
11/576 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
3.3%
19/579 • Number of events 19 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
General Physical Health Deterioration
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
2.2%
13/579 • Number of events 13 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Fatigue
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Pain
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Asthenia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Chest Pain
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Hyperthermia
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Malaise
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Mucosal Inflammation
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Sudden Death
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Administration Site Haematoma
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Generalised Oedema
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Hyperthermia Malignant
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholangitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Jaundice
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Pneumobilia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia
|
2.1%
12/576 • Number of events 12 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.7%
10/579 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Sepsis
|
1.6%
9/576 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.9%
11/579 • Number of events 12 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Respiratory Tract Infection
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Cellulitis
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abdominal Abscess
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Lung Infection
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abscess
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abscess Neck
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Anal Abscess
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Bacteraemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Bronchitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Infected Skin Ulcer
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Muscle Abscess
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Oral Candidiasis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Osteomyelitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pelvic Abscess
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Peritonsillitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia Fungal
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pulmonary Sepsis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Rhinovirus Infection
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Septic Shock
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Sinusitis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Urinary Tract Infection
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.0%
6/579 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Urosepsis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Infection
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Appendicitis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Cystitis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Device Related Sepsis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Erysipelas
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Fungaemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Listeriosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Mastitis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Overdose
|
0.87%
5/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Platelet Count Decreased
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Alanine Aminotransferase Increased
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Anticoagulation Drug Level Above Therapeutic
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Blood Bilirubin Increased
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Transaminases Increased
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
General Physical Condition Abnormal
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Troponin Increased
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Weight Decreased
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Cachexia
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Fracture Pain
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
12.0%
69/576 • Number of events 69 • 6 months treatment + 1 month follow-up
No difference in definition
|
13.3%
77/579 • Number of events 77 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Peritoneum
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Skin
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Meninges
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Squamous Cell Carcinoma
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Uterine Cancer
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Recurrent
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Ischaemic Stroke
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Artery Thrombosis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Infarction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebrospinal Fistula
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Nervous System Disorder
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Neurological Decompensation
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Syncope
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Trigeminal Nerve Disorder
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Disorder
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Headache
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Confusional State
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Depression
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Haematuria
|
1.4%
8/576 • Number of events 10 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Renal Failure
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.0%
6/579 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.4%
8/579 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Hydronephrosis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Prerenal Failure
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Urethral Obstruction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
8/576 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
2.6%
15/579 • Number of events 16 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
7/576 • Number of events 7 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.2%
7/579 • Number of events 7 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
2.6%
15/579 • Number of events 16 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.2%
7/579 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Obstruction
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Thrombosis
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Irritation
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Drug Reaction With Eosinophilia And Systemic Symptoms
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Toxic Skin Eruption
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Hospitalisation
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Elective Surgery
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Cancer Surgery
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Cardiac Operation
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Colostomy
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Ileostomy
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Lung Lobectomy
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Lung Neoplasm Surgery
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Neurosurgery
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Surgery
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Vena Cava Filter Insertion
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Autologous Bone Marrow Transplantation Therapy
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Jejunostomy
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Pain Management
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Vena Cava Filter Removal
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Haemorrhage
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Atheroembolism
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Ischaemia
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Shock Haemorrhagic
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Embolism
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Haematoma
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Hypotension
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Artery Occlusion
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Thrombosis
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
Other adverse events
| Measure |
Apixaban
n=576 participants at risk
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban: Tablets
|
Dalteparin
n=579 participants at risk
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin: Injections
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
33/576 • Number of events 38 • 6 months treatment + 1 month follow-up
No difference in definition
|
3.6%
21/579 • Number of events 27 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
33/576 • Number of events 38 • 6 months treatment + 1 month follow-up
No difference in definition
|
4.1%
24/579 • Number of events 28 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
23/576 • Number of events 23 • 6 months treatment + 1 month follow-up
No difference in definition
|
5.0%
29/579 • Number of events 36 • 6 months treatment + 1 month follow-up
No difference in definition
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60