Trial Outcomes & Findings for Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (NCT NCT00571649)
NCT ID: NCT00571649
Last Updated: 2016-09-15
Results Overview
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8101 participants
Primary outcome timeframe
Up to Day 35 + 6 days
Results posted on
2016-09-15
Participant Flow
First patient first visit date: 04 DEC 2007; last patient last visit date 24 NOV 2010. Primary completion date: 12 AUG 2010. Participants were aged ≥40 years, hospitalized for an acute medical illness, and at risk of Venous Thromboembolism (VTE) (with heart failure, cancer, ischemic stroke, infection or inflammation, or respiratory insufficiency)
A total of 8428 participants were screened; 327 failed. 8101 were randomized. 7998 (98.7%) were in the Safety Analysis Set (SAF), i.e. received study medication. 6024 (74.4%) were in the modified Intent to Treat (at Day 35) group (valid for SAF with adequate assessment of venous thromboembolism). A total of 6005 (74.1%) completed study.
Participant milestones
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
|
Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
|
|---|---|---|
|
Treatment Period
STARTED
|
4050
|
4051
|
|
Treatment Period
Participants Received Treatment
|
3997
|
4001
|
|
Treatment Period
Day 10
|
3454
|
3499
|
|
Treatment Period
Day 35
|
3033
|
3115
|
|
Treatment Period
COMPLETED
|
2958
|
3047
|
|
Treatment Period
NOT COMPLETED
|
1092
|
1004
|
|
Follow-up Period
STARTED
|
3583
|
3635
|
|
Follow-up Period
COMPLETED
|
3038
|
3107
|
|
Follow-up Period
NOT COMPLETED
|
545
|
528
|
Reasons for withdrawal
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
|
Enoxaparin
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
|
|---|---|---|
|
Treatment Period
Adverse Event
|
438
|
385
|
|
Treatment Period
Clinical endpoint reached
|
50
|
56
|
|
Treatment Period
Withdrawal by Subject
|
285
|
255
|
|
Treatment Period
Death
|
76
|
59
|
|
Treatment Period
Physician Decision
|
8
|
9
|
|
Treatment Period
Lost to Follow-up
|
43
|
41
|
|
Treatment Period
Non-compliant with study medication
|
88
|
89
|
|
Treatment Period
Patient convenience
|
11
|
13
|
|
Treatment Period
Protocol Violation
|
90
|
92
|
|
Treatment Period
Technical problems
|
3
|
5
|
|
Follow-up Period
Adverse Event
|
46
|
40
|
|
Follow-up Period
Clinical endpoint reached
|
5
|
2
|
|
Follow-up Period
Withdrawal by Subject
|
119
|
115
|
|
Follow-up Period
Death
|
132
|
133
|
|
Follow-up Period
Physician Decision
|
7
|
13
|
|
Follow-up Period
Lost to Follow-up
|
95
|
92
|
|
Follow-up Period
Patient convenience
|
136
|
121
|
|
Follow-up Period
Protocol Violation
|
5
|
12
|
Baseline Characteristics
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Baseline characteristics by cohort
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
|
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
|
Total
n=7998 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Age, Customized
< 65 years
|
1323 participants
n=5 Participants
|
1363 participants
n=7 Participants
|
2686 participants
n=5 Participants
|
|
Age, Customized
65 to < 75 years
|
1144 participants
n=5 Participants
|
1090 participants
n=7 Participants
|
2234 participants
n=5 Participants
|
|
Age, Customized
>= 75 years
|
1530 participants
n=5 Participants
|
1548 participants
n=7 Participants
|
3078 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1774 Participants
n=5 Participants
|
1898 Participants
n=7 Participants
|
3672 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2223 Participants
n=5 Participants
|
2103 Participants
n=7 Participants
|
4326 Participants
n=5 Participants
|
|
Race
White
|
2749 participants
n=5 Participants
|
2744 participants
n=7 Participants
|
5493 participants
n=5 Participants
|
|
Race
Black
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Race
Asian
|
793 participants
n=5 Participants
|
794 participants
n=7 Participants
|
1587 participants
n=5 Participants
|
|
Race
Native American
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race
Hispanic
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Race
Uncodable
|
106 participants
n=5 Participants
|
112 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Race
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
Missing
|
178 participants
n=5 Participants
|
177 participants
n=7 Participants
|
355 participants
n=5 Participants
|
|
Reason for hospitalization
Heart failure (NYHA Class III or NYHA Class IV)
|
1292 participants
n=5 Participants
|
1301 participants
n=7 Participants
|
2593 participants
n=5 Participants
|
|
Reason for hospitalization
Active cancer
|
294 participants
n=5 Participants
|
290 participants
n=7 Participants
|
584 participants
n=5 Participants
|
|
Reason for hospitalization
Acute ischemic stroke
|
691 participants
n=5 Participants
|
692 participants
n=7 Participants
|
1383 participants
n=5 Participants
|
|
Reason for hospitalization
Acute Infectious and Inflammatory Diseases
|
1904 participants
n=5 Participants
|
1876 participants
n=7 Participants
|
3780 participants
n=5 Participants
|
|
Reason for hospitalization
Acute infectious disease
|
1826 participants
n=5 Participants
|
1801 participants
n=7 Participants
|
3627 participants
n=5 Participants
|
|
Reason for hospitalization
Acute inflammatory or rheumatic disease
|
150 participants
n=5 Participants
|
149 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Reason for hospitalization
Acute respiratory insufficiency
|
1085 participants
n=5 Participants
|
1151 participants
n=7 Participants
|
2236 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 35 + 6 daysPopulation: modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Outcome measures
| Measure |
Enoxaparin
n=3057 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=2967 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
|
5.7 Percentage of participants
|
4.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: Per Protocol (PP) Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations.
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Outcome measures
| Measure |
Enoxaparin
n=2993 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=2938 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
|
2.7 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35 + 6 daysPopulation: modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants who had an assessment of all deaths, including not VTE-related
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Outcome measures
| Measure |
Enoxaparin
n=3169 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3096 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
|
9.2 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: modified Intent-to-Treat (mITT) Day 10: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Outcome measures
| Measure |
Enoxaparin
n=3271 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3232 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
|
3.1 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: modified Intent-to-Treat (mITT) Day 10 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 10) expanded to include participants who had an assessment of all deaths, including not VTE-related
A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Outcome measures
| Measure |
Enoxaparin
n=3310 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3281 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
|
4.5 Percentage of participants
|
4.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 daysPopulation: Safety population: Participant had at least one dose of study drug.
Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90
Outcome measures
| Measure |
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (incl. VTE-related death)-Day 10
|
0.6 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (non fatal)-Day 10
|
0.3 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (non fatal)-Day 35
|
0.7 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (incl. VTE-related death)-Day 90
|
1.9 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (non fatal)-Day 90
|
0.9 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
symptomatic VTE (incl. VTE-related death)-Day 35
|
1.4 Percentage of participants
|
1.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35 + 6 daysPopulation: modified Intent-to-Treat (mITT) Day 35 (participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35) expanded to include participants with major and clinically relevant bleeding events.
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.
Outcome measures
| Measure |
Enoxaparin
n=3082 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3042 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
|
7.8 Percentage of participants
|
9.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: Participants valid for safety analysis, with adequate assessment of VTE (to Day 10 within 48 hours of study drug), met inclusion criteria, and no major protocol deviations; expanded to include participants who had major bleeding or clinically relevant non-major bleeding events and met all criteria for PP except valid assessment of thromboembolism.
Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events
Outcome measures
| Measure |
Enoxaparin
n=3007 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=2950 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days
|
3.9 Percentage of participants
|
4.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 daysPopulation: Safety population: Participant had at least one dose of study drug.
Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.
Outcome measures
| Measure |
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Acute MI-Day 10
|
0.4 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Death (cardiovascular)-Day 10
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Any event-Day 90
|
2.8 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Ischemic stroke-Day 90
|
1.1 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Any event-Day 10
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Ischemic stroke-Day 10
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Any event-Day 35
|
1.6 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Ischemic stroke-Day 35
|
0.5 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Acute MI-Day 35
|
0.5 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Death (cardiovascular)-Day 35
|
0.8 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Acute MI-Day 90
|
0.7 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Death (cardiovascular)-Day 90
|
1.4 Percentage of participants
|
1.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35 + 6 daysPopulation: modified Intent-to-Treat (mITT) Day 35: participant was valid for the safety analysis and had an adequate assessment of VTE up to Day 35
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Outcome measures
| Measure |
Enoxaparin
n=3057 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=2967 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
Asymptomatic proximal DVT in lower extremity
|
4.4 Percentage of participants
|
3.5 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
VTE related death
|
1.0 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
Symptomatic non-fatal PE
|
0.5 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
Symptomatic DVT in lower extremity
|
0.5 Percentage of participants
|
0.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: Per Protocol Day 10: participant was valid for the safety analysis, had an adequate assessment of VTE up to Day 10 not later than 48 hours after stop of study drug, met inclusion criteria, and had no major protocol deviations
The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Outcome measures
| Measure |
Enoxaparin
n=2993 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=2938 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Symptomatic non-fatal PE
|
0.1 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Symptomatic DVT in lower extremity
|
0.2 Percentage of participants
|
0.2 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Asymptomatic proximal DVT in lower extremity
|
2.4 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
VTE related death
|
0.2 Percentage of participants
|
0.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 90 + 7 daysPopulation: Safety population: Participant had at least one dose of study drug.
All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.
Outcome measures
| Measure |
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Any event
|
6.2 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Death (other)
|
3.7 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
VTE related death
|
1.1 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Death (cardiovascular)
|
1.4 Percentage of participants
|
1.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 35 + 6 daysPopulation: Safety population: Participant had at least one dose of study drug.
Major bleeding events were defined as events leading to \>=2 g/dL fall in hemoglobin; or transfusion of \>= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding
Outcome measures
| Measure |
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)
|
1.7 Percentage of participants
|
4.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 10 + 5 daysPopulation: Safety population: Participant had at least one dose of study drug.
Major bleeding events were defined as events leading to \>=2 g/dL fall in hemoglobin or transfusion of \>=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.
Outcome measures
| Measure |
Enoxaparin
n=4001 Participants
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 Participants
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
|---|---|---|
|
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)
|
1.2 Percentage of participants
|
2.8 Percentage of participants
|
Adverse Events
Rivaroxaban (Xarelto, BAY59-7939)
Serious events: 1034 serious events
Other events: 2297 other events
Deaths: 0 deaths
Enoxaparin
Serious events: 976 serious events
Other events: 2291 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 participants at risk
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
Enoxaparin
n=4001 participants at risk
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
|---|---|---|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Epilepsy
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
18/3997 • Number of events 20
|
0.32%
13/4001 • Number of events 13
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.10%
4/3997 • Number of events 5
|
0.07%
3/4001 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3997
|
0.07%
3/4001 • Number of events 3
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.33%
13/3997 • Number of events 13
|
0.22%
9/4001 • Number of events 9
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
30/3997 • Number of events 31
|
0.70%
28/4001 • Number of events 29
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3997 • Number of events 1
|
0.10%
4/4001 • Number of events 4
|
|
Cardiac disorders
Angina unstable
|
0.15%
6/3997 • Number of events 7
|
0.15%
6/4001 • Number of events 6
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Aortic valve stenosis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Cardiac disorders
Arrhythmia
|
0.05%
2/3997 • Number of events 2
|
0.15%
6/4001 • Number of events 6
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
23/3997 • Number of events 23
|
0.55%
22/4001 • Number of events 24
|
|
Cardiac disorders
Atrial flutter
|
0.13%
5/3997 • Number of events 5
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Atrial tachycardia
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Atrioventricular block complete
|
0.08%
3/3997 • Number of events 3
|
0.12%
5/4001 • Number of events 5
|
|
Cardiac disorders
Bradycardia
|
0.03%
1/3997 • Number of events 1
|
0.10%
4/4001 • Number of events 4
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
12/3997 • Number of events 13
|
0.27%
11/4001 • Number of events 12
|
|
Cardiac disorders
Cardiac failure
|
1.9%
76/3997 • Number of events 84
|
1.9%
76/4001 • Number of events 81
|
|
Cardiac disorders
Cardiac failure acute
|
0.28%
11/3997 • Number of events 12
|
0.62%
25/4001 • Number of events 28
|
|
Cardiac disorders
Cardiac failure chronic
|
0.25%
10/3997 • Number of events 10
|
0.25%
10/4001 • Number of events 11
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
31/3997 • Number of events 37
|
0.77%
31/4001 • Number of events 38
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.28%
11/3997 • Number of events 11
|
0.30%
12/4001 • Number of events 12
|
|
Cardiac disorders
Cardiogenic shock
|
0.15%
6/3997 • Number of events 6
|
0.10%
4/4001 • Number of events 4
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 2
|
|
Cardiac disorders
Cor pulmonale
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
12/3997 • Number of events 13
|
0.17%
7/4001 • Number of events 8
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Cardiac disorders
Left ventricular failure
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
3/3997 • Number of events 3
|
0.15%
6/4001 • Number of events 6
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Pericarditis
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Right ventricular failure
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Trifascicular block
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Ventricular fibrillation
|
0.10%
4/3997 • Number of events 6
|
0.07%
3/4001 • Number of events 3
|
|
Cardiac disorders
Ventricular tachycardia
|
0.18%
7/3997 • Number of events 8
|
0.02%
1/4001 • Number of events 2
|
|
Cardiac disorders
Intracardiac thrombus
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Cardiac disorders
Atrial thrombosis
|
0.10%
4/3997 • Number of events 4
|
0.00%
0/4001
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.13%
5/3997 • Number of events 5
|
0.20%
8/4001 • Number of events 8
|
|
Cardiac disorders
Acute coronary syndrome
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Haemorrhage coronary artery
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Cardiac disorders
Cardiac perforation
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Cardiac fibrillation
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Rheumatic heart disease
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Acute left ventricular failure
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Cardiac disorders
Chronotropic incompetence
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Congenital, familial and genetic disorders
Myotonic dystrophy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Ear and labyrinth disorders
Vertigo
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Eye disorders
Cataract
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Eye haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Keratitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Macular degeneration
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Macular oedema
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Optic atrophy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Periorbital oedema
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Pupils unequal
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Eye disorders
Entropion
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
6/3997 • Number of events 7
|
0.10%
4/4001 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Acute abdomen
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Ascites
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
5/3997 • Number of events 6
|
0.25%
10/4001 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3997
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
12/3997 • Number of events 12
|
0.17%
7/4001 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.08%
3/3997 • Number of events 3
|
0.10%
4/4001 • Number of events 4
|
|
Gastrointestinal disorders
Haematochezia
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.15%
6/3997 • Number of events 6
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 2
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
5/3997 • Number of events 5
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Melaena
|
0.15%
6/3997 • Number of events 6
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.08%
3/3997 • Number of events 3
|
0.12%
5/4001 • Number of events 7
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Peritonitis
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.10%
4/3997 • Number of events 4
|
0.10%
4/4001 • Number of events 5
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
7/3997 • Number of events 7
|
0.10%
4/4001 • Number of events 5
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 3
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Internal hernia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Hernial eventration
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Asthenia
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Chest pain
|
0.25%
10/3997 • Number of events 10
|
0.40%
16/4001 • Number of events 18
|
|
General disorders
Chills
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Death
|
0.35%
14/3997 • Number of events 14
|
0.22%
9/4001 • Number of events 9
|
|
General disorders
Fatigue
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
General disorders
Impaired healing
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Malaise
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.20%
8/3997 • Number of events 8
|
0.12%
5/4001 • Number of events 5
|
|
General disorders
Oedema
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Oedema peripheral
|
0.05%
2/3997 • Number of events 2
|
0.12%
5/4001 • Number of events 6
|
|
General disorders
Pain
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 3
|
|
General disorders
Pyrexia
|
0.20%
8/3997 • Number of events 8
|
0.22%
9/4001 • Number of events 9
|
|
General disorders
Sudden death
|
0.20%
8/3997 • Number of events 8
|
0.12%
5/4001 • Number of events 5
|
|
General disorders
Performance status decreased
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 3
|
|
General disorders
Hernia pain
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Sudden cardiac death
|
0.05%
2/3997 • Number of events 2
|
0.17%
7/4001 • Number of events 7
|
|
General disorders
General physical health deterioration
|
0.13%
5/3997 • Number of events 5
|
0.10%
4/4001 • Number of events 4
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Nodule
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Ulcer haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Drug intolerance
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Unevaluable event
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
General disorders
Implant site haematoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Device malfunction
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Device dislocation
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Device occlusion
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
General disorders
Disuse syndrome
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
General disorders
Device capturing issue
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Cholecystitis
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
2/3997 • Number of events 2
|
0.10%
4/4001 • Number of events 4
|
|
Hepatobiliary disorders
Cholestasis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.18%
7/3997 • Number of events 7
|
0.12%
5/4001 • Number of events 5
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Haemobilia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Appendicitis perforated
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Bacteraemia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Bronchiectasis
|
0.08%
3/3997 • Number of events 3
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Bronchiolitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Bronchitis
|
0.45%
18/3997 • Number of events 18
|
0.10%
4/4001 • Number of events 4
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
8/3997 • Number of events 8
|
0.25%
10/4001 • Number of events 10
|
|
Infections and infestations
Cellulitis
|
0.50%
20/3997 • Number of events 23
|
0.22%
9/4001 • Number of events 10
|
|
Infections and infestations
Cellulitis streptococcal
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Disseminated tuberculosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Diverticulitis
|
0.13%
5/3997 • Number of events 5
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Empyema
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 3
|
|
Infections and infestations
Enteritis necroticans
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Erysipelas
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Furuncle
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Gangrene
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
0.30%
12/3997 • Number of events 12
|
0.10%
4/4001 • Number of events 4
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Hepatitis C
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Herpes zoster
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Impetigo
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Infection
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
4/3997 • Number of events 4
|
0.07%
3/4001 • Number of events 3
|
|
Infections and infestations
Lung abscess
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Meningitis
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Oesophageal candidiasis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Peridiverticular abscess
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.9%
74/3997 • Number of events 78
|
1.9%
76/4001 • Number of events 78
|
|
Infections and infestations
Pneumonia klebsiella
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Pyometra
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pyothorax
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Retroperitoneal abscess
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.73%
29/3997 • Number of events 30
|
0.35%
14/4001 • Number of events 14
|
|
Infections and infestations
Septic shock
|
0.38%
15/3997 • Number of events 16
|
0.45%
18/4001 • Number of events 20
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.43%
17/3997 • Number of events 20
|
0.32%
13/4001 • Number of events 14
|
|
Infections and infestations
Viral infection
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Wound infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.10%
4/3997 • Number of events 4
|
0.15%
6/4001 • Number of events 6
|
|
Infections and infestations
Abscess limb
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Infections and infestations
Burn infection
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Haematoma infection
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Bacterial sepsis
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Sepsis syndrome
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Psoas abscess
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Phlebitis infective
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.25%
10/3997 • Number of events 10
|
0.30%
12/4001 • Number of events 12
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Abdominal sepsis
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Infections and infestations
Wound sepsis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Tuberculosis liver
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Enterocolitis infectious
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Infections and infestations
Wound infection staphylococcal
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Infections and infestations
Diabetic foot infection
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Lung infection
|
0.05%
2/3997 • Number of events 2
|
0.10%
4/4001 • Number of events 4
|
|
Infections and infestations
Pneumonia fungal
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
10/3997 • Number of events 12
|
0.15%
6/4001 • Number of events 6
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
H1N1 influenza
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Infections and infestations
Device related sepsis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Eye penetration
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
5/3997 • Number of events 5
|
0.07%
3/4001 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.05%
2/3997 • Number of events 2
|
0.10%
4/4001 • Number of events 4
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.13%
5/3997 • Number of events 5
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.50%
20/3997 • Number of events 20
|
0.57%
23/4001 • Number of events 26
|
|
Investigations
Arteriogram coronary
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3997 • Number of events 1
|
0.12%
5/4001 • Number of events 7
|
|
Investigations
Biopsy lymph gland
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.10%
4/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Blood glucose abnormal
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Blood glucose decreased
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Blood glucose increased
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Investigations
Creatinine renal clearance decreased
|
0.10%
4/3997 • Number of events 4
|
0.07%
3/4001 • Number of events 3
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.05%
2/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Immunoglobulins increased
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.20%
8/3997 • Number of events 8
|
0.12%
5/4001 • Number of events 5
|
|
Investigations
Prothrombin time prolonged
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Weight decreased
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Investigations
Aspiration bronchial
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Transaminases increased
|
0.08%
3/3997 • Number of events 3
|
0.05%
2/4001 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
Hepatic enzyme increased
|
0.25%
10/3997 • Number of events 10
|
0.27%
11/4001 • Number of events 11
|
|
Investigations
Occult blood positive
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Investigations
Coagulation test
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Investigations
False positive investigation result
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Metabolism and nutrition disorders
Cachexia
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
9/3997 • Number of events 9
|
0.12%
5/4001 • Number of events 5
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
1/3997 • Number of events 1
|
0.10%
4/4001 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.08%
3/3997 • Number of events 3
|
0.17%
7/4001 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3997
|
0.07%
3/4001 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
4/3997 • Number of events 5
|
0.10%
4/4001 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.08%
3/3997 • Number of events 3
|
0.07%
3/4001 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.08%
3/3997 • Number of events 3
|
0.10%
4/4001 • Number of events 4
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.05%
2/3997 • Number of events 3
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
2/3997 • Number of events 3
|
0.10%
4/4001 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
5/3997 • Number of events 5
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer stage IV
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3997
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.15%
6/3997 • Number of events 6
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.05%
2/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.03%
1/3997 • Number of events 1
|
0.10%
4/4001 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.03%
1/3997 • Number of events 1
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloma recurrence
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.08%
3/3997 • Number of events 3
|
0.10%
4/4001 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary cancer metastatic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.40%
16/3997 • Number of events 18
|
0.27%
11/4001 • Number of events 11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.10%
4/3997 • Number of events 4
|
0.07%
3/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.08%
3/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraproteinaemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural neoplasm
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.10%
4/3997 • Number of events 5
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Carotid artery stenosis
|
0.10%
4/3997 • Number of events 4
|
0.00%
0/4001
|
|
Nervous system disorders
Cauda equina syndrome
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Cerebral atrophy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
4/3997 • Number of events 4
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Cerebral ischaemia
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
5/3997 • Number of events 5
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Nervous system disorders
Dementia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Hydrocephalus
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Loss of consciousness
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Myoclonus
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Radiculopathy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Spinal cord compression
|
0.10%
4/3997 • Number of events 4
|
0.00%
0/4001
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.38%
15/3997 • Number of events 18
|
0.25%
10/4001 • Number of events 10
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.10%
4/3997 • Number of events 4
|
0.25%
10/4001 • Number of events 10
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Carotid artery occlusion
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Quadriparesis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Nervous system disorders
Vascular dementia
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.75%
30/3997 • Number of events 31
|
0.97%
39/4001 • Number of events 40
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Acute polyneuropathy
|
0.03%
1/3997 • Number of events 3
|
0.00%
0/4001
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Psychiatric disorders
Anorexia nervosa
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.03%
1/3997 • Number of events 1
|
0.12%
5/4001 • Number of events 5
|
|
Psychiatric disorders
Disorientation
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Psychiatric disorders
Panic attack
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Somatisation disorder
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Bipolar disorder
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 2
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 2
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Anuria
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 2
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Haematuria
|
0.23%
9/3997 • Number of events 9
|
0.17%
7/4001 • Number of events 7
|
|
Renal and urinary disorders
Nephritis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Proteinuria
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Renal failure
|
0.30%
12/3997 • Number of events 12
|
0.35%
14/4001 • Number of events 14
|
|
Renal and urinary disorders
Renal failure acute
|
0.78%
31/3997 • Number of events 32
|
0.40%
16/4001 • Number of events 16
|
|
Renal and urinary disorders
Renal failure chronic
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Urinary retention
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Renal and urinary disorders
Cystitis glandularis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Renal and urinary disorders
Pulmonary renal syndrome
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Reproductive system and breast disorders
Perineal fistula
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.20%
8/3997 • Number of events 8
|
0.12%
5/4001 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3997 • Number of events 1
|
0.12%
5/4001 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
35/3997 • Number of events 37
|
0.30%
12/4001 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
8/3997 • Number of events 9
|
0.15%
6/4001 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.08%
3/3997 • Number of events 3
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.7%
109/3997 • Number of events 138
|
2.6%
104/4001 • Number of events 131
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.05%
2/3997 • Number of events 2
|
0.10%
4/4001 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
19/3997 • Number of events 20
|
0.42%
17/4001 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
4/3997 • Number of events 4
|
0.10%
4/4001 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.23%
9/3997 • Number of events 9
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3997 • Number of events 1
|
0.12%
5/4001 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
9/3997 • Number of events 11
|
0.25%
10/4001 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
4/3997 • Number of events 4
|
0.27%
11/4001 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.03%
1/3997 • Number of events 1
|
0.10%
4/4001 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
4/3997 • Number of events 4
|
0.10%
4/4001 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.08%
3/3997 • Number of events 4
|
0.07%
3/4001 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.08%
3/3997 • Number of events 3
|
0.05%
2/4001 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.23%
9/3997 • Number of events 9
|
0.35%
14/4001 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
56/3997 • Number of events 59
|
1.00%
40/4001 • Number of events 41
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.08%
3/3997 • Number of events 4
|
0.02%
1/4001 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.15%
6/3997 • Number of events 6
|
0.07%
3/4001 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Social circumstances
Disability
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Social circumstances
Social problem
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Surgical and medical procedures
Radical hysterectomy
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Surgical and medical procedures
Tumour excision
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Surgical and medical procedures
Chemotherapy
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Surgical and medical procedures
Mitral valve repair
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Aortic stenosis
|
0.08%
3/3997 • Number of events 5
|
0.07%
3/4001 • Number of events 3
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Arterial rupture
|
0.03%
1/3997 • Number of events 2
|
0.00%
0/4001
|
|
Vascular disorders
Arterial thrombosis limb
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Vascular disorders
Arteriosclerosis
|
0.08%
3/3997 • Number of events 3
|
0.00%
0/4001
|
|
Vascular disorders
Arteritis
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Bleeding varicose vein
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Essential hypertension
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/3997
|
0.05%
2/4001 • Number of events 2
|
|
Vascular disorders
Femoral artery aneurysm
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Haematoma
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Hypertension
|
0.18%
7/3997 • Number of events 7
|
0.10%
4/4001 • Number of events 4
|
|
Vascular disorders
Hypertensive crisis
|
0.08%
3/3997 • Number of events 3
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.25%
10/3997 • Number of events 10
|
0.17%
7/4001 • Number of events 7
|
|
Vascular disorders
Hypovolaemic shock
|
0.05%
2/3997 • Number of events 2
|
0.05%
2/4001 • Number of events 2
|
|
Vascular disorders
Iliac artery thrombosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Lymphoedema
|
0.03%
1/3997 • Number of events 1
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Vascular disorders
Peripheral ischaemia
|
0.08%
3/3997 • Number of events 3
|
0.12%
5/4001 • Number of events 5
|
|
Vascular disorders
Shock
|
0.05%
2/3997 • Number of events 2
|
0.07%
3/4001 • Number of events 3
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Vascular disorders
Vasculitis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Shock haemorrhagic
|
0.05%
2/3997 • Number of events 2
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
4/3997 • Number of events 4
|
0.12%
5/4001 • Number of events 5
|
|
Vascular disorders
Haemorrhage
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Superior vena caval occlusion
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Extremity necrosis
|
0.03%
1/3997 • Number of events 1
|
0.00%
0/4001
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3997 • Number of events 1
|
0.05%
2/4001 • Number of events 2
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.05%
2/3997 • Number of events 3
|
0.05%
2/4001 • Number of events 2
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/3997
|
0.02%
1/4001 • Number of events 1
|
|
Vascular disorders
Aortic dissection rupture
|
0.05%
2/3997 • Number of events 2
|
0.00%
0/4001
|
Other adverse events
| Measure |
Rivaroxaban (Xarelto, BAY59-7939)
n=3997 participants at risk
Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
|
Enoxaparin
n=4001 participants at risk
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
87/3997 • Number of events 93
|
2.1%
85/4001 • Number of events 87
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.50%
20/3997 • Number of events 32
|
0.40%
16/4001 • Number of events 20
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.73%
29/3997 • Number of events 32
|
0.62%
25/4001 • Number of events 27
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
74/3997 • Number of events 82
|
1.5%
61/4001 • Number of events 65
|
|
Cardiac disorders
Cardiac failure
|
1.1%
43/3997 • Number of events 46
|
0.95%
38/4001 • Number of events 44
|
|
Cardiac disorders
Mitral valve incompetence
|
0.90%
36/3997 • Number of events 36
|
0.80%
32/4001 • Number of events 33
|
|
Cardiac disorders
Tachycardia
|
0.80%
32/3997 • Number of events 33
|
1.1%
43/4001 • Number of events 49
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.48%
19/3997 • Number of events 19
|
0.55%
22/4001 • Number of events 22
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.60%
24/3997 • Number of events 26
|
0.42%
17/4001 • Number of events 17
|
|
Ear and labyrinth disorders
Vertigo
|
0.65%
26/3997 • Number of events 26
|
0.62%
25/4001 • Number of events 26
|
|
Eye disorders
Conjunctivitis
|
0.40%
16/3997 • Number of events 16
|
0.60%
24/4001 • Number of events 24
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
89/3997 • Number of events 109
|
1.4%
56/4001 • Number of events 64
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
59/3997 • Number of events 63
|
1.3%
53/4001 • Number of events 62
|
|
Gastrointestinal disorders
Constipation
|
9.1%
362/3997 • Number of events 418
|
8.6%
346/4001 • Number of events 375
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
214/3997 • Number of events 238
|
5.7%
230/4001 • Number of events 256
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
53/3997 • Number of events 54
|
1.5%
62/4001 • Number of events 69
|
|
Gastrointestinal disorders
Gastritis
|
0.90%
36/3997 • Number of events 37
|
0.95%
38/4001 • Number of events 38
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.50%
20/3997 • Number of events 21
|
0.47%
19/4001 • Number of events 19
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.50%
20/3997 • Number of events 22
|
0.22%
9/4001 • Number of events 9
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.50%
20/3997 • Number of events 20
|
0.40%
16/4001 • Number of events 16
|
|
Gastrointestinal disorders
Nausea
|
5.2%
207/3997 • Number of events 242
|
5.6%
226/4001 • Number of events 253
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
170/3997 • Number of events 205
|
3.7%
149/4001 • Number of events 175
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.55%
22/3997 • Number of events 23
|
0.30%
12/4001 • Number of events 12
|
|
General disorders
Asthenia
|
1.3%
52/3997 • Number of events 54
|
0.77%
31/4001 • Number of events 32
|
|
General disorders
Chest pain
|
2.2%
89/3997 • Number of events 102
|
1.9%
77/4001 • Number of events 82
|
|
General disorders
Fatigue
|
0.83%
33/3997 • Number of events 35
|
0.87%
35/4001 • Number of events 35
|
|
General disorders
Injection site haemorrhage
|
0.20%
8/3997 • Number of events 8
|
0.52%
21/4001 • Number of events 23
|
|
General disorders
Oedema peripheral
|
3.3%
132/3997 • Number of events 153
|
2.9%
115/4001 • Number of events 127
|
|
General disorders
Pain
|
1.1%
42/3997 • Number of events 46
|
0.97%
39/4001 • Number of events 40
|
|
General disorders
Pyrexia
|
3.3%
132/3997 • Number of events 158
|
3.3%
131/4001 • Number of events 162
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
49/3997 • Number of events 50
|
1.2%
47/4001 • Number of events 48
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.43%
17/3997 • Number of events 18
|
0.60%
24/4001 • Number of events 24
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.2%
48/3997 • Number of events 48
|
1.5%
61/4001 • Number of events 61
|
|
Infections and infestations
Bronchitis
|
1.6%
64/3997 • Number of events 65
|
1.2%
47/4001 • Number of events 48
|
|
Infections and infestations
Cellulitis
|
0.55%
22/3997 • Number of events 22
|
0.45%
18/4001 • Number of events 19
|
|
Infections and infestations
Nasopharyngitis
|
0.93%
37/3997 • Number of events 38
|
0.90%
36/4001 • Number of events 36
|
|
Infections and infestations
Oral candidiasis
|
0.78%
31/3997 • Number of events 31
|
0.85%
34/4001 • Number of events 35
|
|
Infections and infestations
Pneumonia
|
1.8%
73/3997 • Number of events 75
|
1.6%
65/4001 • Number of events 68
|
|
Infections and infestations
Upper respiratory tract infection
|
0.75%
30/3997 • Number of events 33
|
0.65%
26/4001 • Number of events 27
|
|
Infections and infestations
Urinary tract infection
|
3.5%
138/3997 • Number of events 148
|
3.5%
142/4001 • Number of events 151
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
33/3997 • Number of events 38
|
1.00%
40/4001 • Number of events 40
|
|
Injury, poisoning and procedural complications
Contusion
|
0.95%
38/3997 • Number of events 50
|
1.0%
42/4001 • Number of events 63
|
|
Investigations
Alanine aminotransferase increased
|
0.80%
32/3997 • Number of events 32
|
1.5%
61/4001 • Number of events 66
|
|
Investigations
Aspartate aminotransferase increased
|
0.58%
23/3997 • Number of events 23
|
0.87%
35/4001 • Number of events 36
|
|
Investigations
Blood creatinine increased
|
0.95%
38/3997 • Number of events 40
|
0.90%
36/4001 • Number of events 39
|
|
Investigations
Blood urea increased
|
0.60%
24/3997 • Number of events 27
|
0.57%
23/4001 • Number of events 24
|
|
Investigations
Creatinine renal clearance decreased
|
0.90%
36/3997 • Number of events 40
|
0.87%
35/4001 • Number of events 35
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.78%
31/3997 • Number of events 31
|
0.80%
32/4001 • Number of events 32
|
|
Investigations
Haemoglobin decreased
|
0.58%
23/3997 • Number of events 26
|
0.30%
12/4001 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
43/3997 • Number of events 49
|
0.75%
30/4001 • Number of events 30
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.98%
39/3997 • Number of events 40
|
0.85%
34/4001 • Number of events 34
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
46/3997 • Number of events 54
|
1.2%
50/4001 • Number of events 63
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
62/3997 • Number of events 66
|
1.3%
51/4001 • Number of events 57
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
37/3997 • Number of events 46
|
0.97%
39/4001 • Number of events 48
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
191/3997 • Number of events 219
|
4.6%
184/4001 • Number of events 219
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
35/3997 • Number of events 38
|
0.85%
34/4001 • Number of events 34
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.95%
38/3997 • Number of events 42
|
1.00%
40/4001 • Number of events 44
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
62/3997 • Number of events 68
|
1.9%
76/4001 • Number of events 87
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
97/3997 • Number of events 105
|
2.0%
82/4001 • Number of events 85
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.63%
25/3997 • Number of events 25
|
0.70%
28/4001 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
46/3997 • Number of events 50
|
1.5%
61/4001 • Number of events 66
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.35%
14/3997 • Number of events 14
|
0.55%
22/4001 • Number of events 25
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
29/3997 • Number of events 30
|
0.55%
22/4001 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
110/3997 • Number of events 127
|
2.6%
103/4001 • Number of events 113
|
|
Nervous system disorders
Dizziness
|
2.0%
81/3997 • Number of events 83
|
1.8%
72/4001 • Number of events 80
|
|
Nervous system disorders
Headache
|
5.1%
205/3997 • Number of events 237
|
4.6%
185/4001 • Number of events 221
|
|
Nervous system disorders
Syncope
|
0.58%
23/3997 • Number of events 24
|
0.47%
19/4001 • Number of events 21
|
|
Psychiatric disorders
Anxiety
|
2.2%
89/3997 • Number of events 99
|
2.3%
94/4001 • Number of events 98
|
|
Psychiatric disorders
Confusional state
|
0.70%
28/3997 • Number of events 28
|
0.57%
23/4001 • Number of events 24
|
|
Psychiatric disorders
Depression
|
1.7%
68/3997 • Number of events 68
|
1.8%
73/4001 • Number of events 77
|
|
Psychiatric disorders
Insomnia
|
4.3%
172/3997 • Number of events 199
|
4.6%
185/4001 • Number of events 202
|
|
Psychiatric disorders
Sleep disorder
|
0.63%
25/3997 • Number of events 25
|
0.40%
16/4001 • Number of events 18
|
|
Renal and urinary disorders
Dysuria
|
0.55%
22/3997 • Number of events 23
|
0.37%
15/4001 • Number of events 15
|
|
Renal and urinary disorders
Haematuria
|
1.6%
65/3997 • Number of events 68
|
1.2%
48/4001 • Number of events 53
|
|
Renal and urinary disorders
Renal cyst
|
1.6%
65/3997 • Number of events 65
|
1.5%
61/4001 • Number of events 63
|
|
Renal and urinary disorders
Renal failure
|
1.3%
52/3997 • Number of events 55
|
1.2%
47/4001 • Number of events 48
|
|
Renal and urinary disorders
Renal failure acute
|
0.63%
25/3997 • Number of events 26
|
0.47%
19/4001 • Number of events 19
|
|
Renal and urinary disorders
Urinary retention
|
0.55%
22/3997 • Number of events 23
|
0.42%
17/4001 • Number of events 19
|
|
Renal and urinary disorders
Renal impairment
|
0.98%
39/3997 • Number of events 40
|
0.72%
29/4001 • Number of events 31
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.1%
44/3997 • Number of events 45
|
0.50%
20/4001 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
71/3997 • Number of events 92
|
1.5%
59/4001 • Number of events 84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
107/3997 • Number of events 118
|
2.3%
94/4001 • Number of events 100
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
107/3997 • Number of events 120
|
2.5%
99/4001 • Number of events 112
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
123/3997 • Number of events 145
|
1.6%
66/4001 • Number of events 83
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.93%
37/3997 • Number of events 40
|
0.80%
32/4001 • Number of events 37
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.70%
28/3997 • Number of events 32
|
0.77%
31/4001 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.68%
27/3997 • Number of events 28
|
0.67%
27/4001 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.53%
21/3997 • Number of events 22
|
0.45%
18/4001 • Number of events 23
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
42/3997 • Number of events 47
|
0.97%
39/4001 • Number of events 42
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.68%
27/3997 • Number of events 30
|
0.92%
37/4001 • Number of events 41
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
47/3997 • Number of events 47
|
1.2%
50/4001 • Number of events 51
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
41/3997 • Number of events 44
|
1.2%
50/4001 • Number of events 51
|
|
Vascular disorders
Haematoma
|
0.60%
24/3997 • Number of events 29
|
0.60%
24/4001 • Number of events 26
|
|
Vascular disorders
Hypertension
|
3.9%
154/3997 • Number of events 177
|
3.9%
156/4001 • Number of events 178
|
|
Vascular disorders
Hypertensive crisis
|
0.50%
20/3997 • Number of events 23
|
0.40%
16/4001 • Number of events 18
|
|
Vascular disorders
Hypotension
|
2.1%
82/3997 • Number of events 91
|
2.3%
93/4001 • Number of events 102
|
|
Vascular disorders
Phlebitis
|
0.93%
37/3997 • Number of events 38
|
0.95%
38/4001 • Number of events 41
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.63%
25/3997 • Number of events 25
|
0.47%
19/4001 • Number of events 19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60