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=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
377 Participants
n=5 Participants
|
369 Participants
n=7 Participants
|
746 Participants
n=5 Participants
|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
284 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
587 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
292 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
568 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
456 Participants
n=5 Participants
|
469 Participants
n=7 Participants
|
925 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
107 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
64 participants
n=5 Participants
|
74 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
65 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
204 participants
n=5 Participants
|
193 participants
n=7 Participants
|
397 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
18 participants
n=5 Participants
|
8 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
France
|
102 participants
n=5 Participants
|
90 participants
n=7 Participants
|
192 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
80 participants
n=5 Participants
|
95 participants
n=7 Participants
|
175 participants
n=5 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
Dalteparin
Serious events: 276 serious events
Other events: 74 other events
Deaths: 153 deaths
Apixaban
Serious events: 255 serious events
Other events: 89 other events
Deaths: 135 deaths
Serious adverse events
| Measure |
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
|
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Irritation
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Drug Reaction With Eosinophilia And Systemic Symptoms
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infarction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural Fistula
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Obstruction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Artery Thrombosis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Toxic Skin Eruption
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Hospitalisation
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Elective Surgery
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Cancer Surgery
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Lung Lobectomy
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Lung Neoplasm Surgery
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Neurosurgery
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Surgery
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Vena Cava Filter Insertion
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Autologous Bone Marrow Transplantation Therapy
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Cardiac Operation
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • 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
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Meninges
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Squamous Cell Carcinoma
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Uterine Cancer
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Recurrent
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 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
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Ischaemic Stroke
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Artery Thrombosis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebrospinal Fistula
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Neurological Decompensation
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Syncope
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Trigeminal Nerve Disorder
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Disorder
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Headache
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Nervous system disorders
Spinal Cord Compression
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Bipolar Disorder
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Depression
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Psychiatric disorders
Disorientation
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Haematuria
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.4%
8/576 • Number of events 10 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Renal Failure
|
1.0%
6/579 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.4%
8/579 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Hydronephrosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Prerenal Failure
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Renal and urinary disorders
Urethral Obstruction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.6%
15/579 • Number of events 16 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.4%
8/576 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
7/579 • Number of events 7 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.2%
7/576 • Number of events 7 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
15/579 • Number of events 16 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.2%
7/579 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Anaemia
|
0.69%
4/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.0%
6/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Anaemia Of Malignant Disease
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Bone Marrow Failure
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Anaemia Of Chronic Disease
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Fibrillation
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Myocardial Infarction
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardiac Failure
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Angina Unstable
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Flutter
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Atrial Thrombosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Pericarditis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Sinus Tachycardia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Cardiac disorders
Tachycardia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.4%
8/576 • Number of events 10 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
9/579 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.2%
7/576 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.0%
6/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Melaena
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Ascites
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Diarrhoea
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Ileus
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Fistula
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Intestinal Pseudo-Obstruction
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Nausea
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Thrombosis Mesenteric Vessel
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haematemesis
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haematochezia
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Diaphragmatic Hernia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Duodenal Stenosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Enteritis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Dilatation
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haemorrhagic Ascites
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Condition Aggravated
|
3.3%
19/579 • Number of events 24 • 6 months treatment + 1 month follow-up
No difference in definition
|
3.8%
22/576 • Number of events 22 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Pyrexia
|
1.6%
9/579 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
2.1%
12/576 • Number of events 13 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Death
|
3.3%
19/579 • Number of events 19 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.9%
11/576 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
General Physical Health Deterioration
|
2.2%
13/579 • Number of events 13 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Fatigue
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Pain
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Asthenia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Chest Pain
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Hyperthermia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Malaise
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Sudden Death
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Non-Cardiac Chest Pain
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Administration Site Haematoma
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Generalised Oedema
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Hyperthermia Malignant
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholangitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Gallbladder Perforation
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Jaundice
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Biliary Colic
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia
|
1.7%
10/579 • Number of events 11 • 6 months treatment + 1 month follow-up
No difference in definition
|
2.1%
12/576 • Number of events 12 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Sepsis
|
1.9%
11/579 • Number of events 12 • 6 months treatment + 1 month follow-up
No difference in definition
|
1.6%
9/576 • Number of events 9 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Respiratory Tract Infection
|
0.69%
4/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Cellulitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Lung Infection
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Abscess Neck
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Bronchitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Muscle Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Septic Shock
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Sinusitis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
6/579 • Number of events 8 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Urosepsis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Infection
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Appendicitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Biliary Tract Infection
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Cystitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Device Related Sepsis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Erysipelas
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Fungaemia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Listeriosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Mastitis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pneumonia Bacterial
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pyelonephritis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Infections and infestations
Pyelonephritis Acute
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Overdose
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 6 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Platelet Count Decreased
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Alanine Aminotransferase Increased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Anticoagulation Drug Level Above Therapeutic
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Transaminases Increased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
General Physical Condition Abnormal
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Troponin Increased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
Weight Decreased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Investigations
White Blood Cell Count Decreased
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Cachexia
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.69%
4/576 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.52%
3/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.52%
3/579 • Number of events 3 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Fracture Pain
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
13.3%
77/579 • Number of events 77 • 6 months treatment + 1 month follow-up
No difference in definition
|
12.0%
69/576 • Number of events 69 • 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
|
0.69%
4/579 • Number of events 4 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.52%
3/576 • 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 Liver
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • 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%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • 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
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • 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 Neoplasm
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Jejunostomy
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Mastectomy
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Pain Management
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Surgical and medical procedures
Vena Cava Filter Removal
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.86%
5/579 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.87%
5/576 • Number of events 5 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Haemorrhage
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.35%
2/576 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Atheroembolism
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/579 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Shock Haemorrhagic
|
0.35%
2/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.17%
1/576 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Embolism
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Haematoma
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Hypotension
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Artery Occlusion
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.17%
1/579 • Number of events 2 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Vascular disorders
Thrombosis
|
0.17%
1/579 • Number of events 1 • 6 months treatment + 1 month follow-up
No difference in definition
|
0.00%
0/576 • 6 months treatment + 1 month follow-up
No difference in definition
|
Other adverse events
| Measure |
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
|
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
21/579 • Number of events 27 • 6 months treatment + 1 month follow-up
No difference in definition
|
5.7%
33/576 • Number of events 38 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.1%
24/579 • Number of events 28 • 6 months treatment + 1 month follow-up
No difference in definition
|
5.7%
33/576 • Number of events 38 • 6 months treatment + 1 month follow-up
No difference in definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
29/579 • Number of events 36 • 6 months treatment + 1 month follow-up
No difference in definition
|
4.0%
23/576 • Number of events 23 • 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