Trial Outcomes & Findings for ASCEND: A Study of Cardiovascular Events iN Diabetes (NCT NCT00135226)
NCT ID: NCT00135226
Last Updated: 2025-05-28
Results Overview
The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision \[ICD-10\] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage \[I60\], intracerebral hemorrhage \[I61\], and other non-traumatic intracranial hemorrhage \[I62\]).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
15480 participants
Primary outcome timeframe
Randomized treatment phase during a mean of 7.4 years
Results posted on
2025-05-28
Participant Flow
Participants were randomized between June 2005 through July 2011. Follow-up continued until March 2018.
Participant milestones
| Measure |
Aspirin + Omega-3 Ethyl Esters
Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily.
Aspirin
Omega-3 ethyl esters
|
Aspirin + Placebo Omega-3 Ethyl Esters
Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily.
Aspirin
Placebo omega-3 ethyl esters
|
Placebo Aspirin + Omega-3 Ethyl Esters
Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily.
Placebo aspirin
Omega-3 ethyl esters
|
Placebo Aspirin + Placebo Omega-3 Ethyl Esters
Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily.
Placebo aspirin
Placebo omega-3 ethyl esters
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3870
|
3870
|
3870
|
3870
|
|
Overall Study
COMPLETED
|
3836
|
3835
|
3836
|
3834
|
|
Overall Study
NOT COMPLETED
|
34
|
35
|
34
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ASCEND: A Study of Cardiovascular Events iN Diabetes
Baseline characteristics by cohort
| Measure |
Aspirin + Omega-3
n=3870 Participants
Participants receive 100mg of aspirin once daily and 1g of omega-3 ethyl esters once daily.
|
Aspirin + Placebo Omega-3
n=3870 Participants
Participants receive 100mg of aspirin once daily and placebo omega-3 ethyl esters once daily.
|
Placebo Aspirin + Omega-3
n=3870 Participants
Participants receive placebo aspirin once daily and 1g of omega-3 ethyl esters once daily.
|
Placebo Aspirin + Placebo Omega-3
n=3870 Participants
Participants receive placebo aspirin once daily and placebo omega-3 ethyl esters once daily.
|
Total
n=15480 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2257 Participants
n=5 Participants
|
2259 Participants
n=7 Participants
|
2257 Participants
n=5 Participants
|
2261 Participants
n=4 Participants
|
9034 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1613 Participants
n=5 Participants
|
1611 Participants
n=7 Participants
|
1613 Participants
n=5 Participants
|
1609 Participants
n=4 Participants
|
6446 Participants
n=21 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
63.3 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1448 Participants
n=5 Participants
|
1449 Participants
n=7 Participants
|
1450 Participants
n=5 Participants
|
1449 Participants
n=4 Participants
|
5796 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2422 Participants
n=5 Participants
|
2421 Participants
n=7 Participants
|
2420 Participants
n=5 Participants
|
2421 Participants
n=4 Participants
|
9684 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · White
|
3733 Participants
n=5 Participants
|
3734 Participants
n=7 Participants
|
3734 Participants
n=5 Participants
|
3734 Participants
n=4 Participants
|
14935 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Indian/Pakistani/Bangladeshi
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
184 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · African/Caribbean
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Other/unknown
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
221 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
3870 participants
n=5 Participants
|
3870 participants
n=7 Participants
|
3870 participants
n=5 Participants
|
3870 participants
n=4 Participants
|
15480 participants
n=21 Participants
|
|
Body-mass index (kg/m²)
<25
|
522 Participants
n=5 Participants
|
558 Participants
n=7 Participants
|
607 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
2249 Participants
n=21 Participants
|
|
Body-mass index (kg/m²)
≥25 to <30
|
1356 Participants
n=5 Participants
|
1397 Participants
n=7 Participants
|
1415 Participants
n=5 Participants
|
1361 Participants
n=4 Participants
|
5529 Participants
n=21 Participants
|
|
Body-mass index (kg/m²)
≥30
|
1863 Participants
n=5 Participants
|
1802 Participants
n=7 Participants
|
1721 Participants
n=5 Participants
|
1815 Participants
n=4 Participants
|
7201 Participants
n=21 Participants
|
|
Body-mass index (kg/m²)
Unknown
|
129 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
501 Participants
n=21 Participants
|
|
Body-mass index (mean)
|
30.9 kg/m²
STANDARD_DEVIATION 6.3 • n=5 Participants
|
30.8 kg/m²
STANDARD_DEVIATION 6.2 • n=7 Participants
|
30.5 kg/m²
STANDARD_DEVIATION 6.3 • n=5 Participants
|
30.7 kg/m²
STANDARD_DEVIATION 6.3 • n=4 Participants
|
30.7 kg/m²
STANDARD_DEVIATION 6.3 • n=21 Participants
|
|
Smoking status
Current smoker
|
319 Participants
n=5 Participants
|
320 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
1279 Participants
n=21 Participants
|
|
Smoking status
Ex-smoker
|
1764 Participants
n=5 Participants
|
1762 Participants
n=7 Participants
|
1763 Participants
n=5 Participants
|
1762 Participants
n=4 Participants
|
7051 Participants
n=21 Participants
|
|
Smoking status
Never smoked
|
1745 Participants
n=5 Participants
|
1744 Participants
n=7 Participants
|
1744 Participants
n=5 Participants
|
1744 Participants
n=4 Participants
|
6977 Participants
n=21 Participants
|
|
Smoking status
Unknown
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Treated hypertension
Yes
|
2384 Participants
n=5 Participants
|
2382 Participants
n=7 Participants
|
2384 Participants
n=5 Participants
|
2383 Participants
n=4 Participants
|
9533 Participants
n=21 Participants
|
|
Treated hypertension
No
|
1459 Participants
n=5 Participants
|
1460 Participants
n=7 Participants
|
1458 Participants
n=5 Participants
|
1458 Participants
n=4 Participants
|
5835 Participants
n=21 Participants
|
|
Treated hypertension
Unknown
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Aspirin use prior to screening
Yes
|
1373 Participants
n=5 Participants
|
1367 Participants
n=7 Participants
|
1371 Participants
n=5 Participants
|
1397 Participants
n=4 Participants
|
5508 Participants
n=21 Participants
|
|
Aspirin use prior to screening
No
|
2497 Participants
n=5 Participants
|
2503 Participants
n=7 Participants
|
2499 Participants
n=5 Participants
|
2473 Participants
n=4 Participants
|
9972 Participants
n=21 Participants
|
|
Type of diabetes
Type 1
|
226 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
911 Participants
n=21 Participants
|
|
Type of diabetes
Type 2
|
3644 Participants
n=5 Participants
|
3638 Participants
n=7 Participants
|
3636 Participants
n=5 Participants
|
3651 Participants
n=4 Participants
|
14569 Participants
n=21 Participants
|
|
Duration of diabetes (years)
<6 yr
|
2172 Participants
n=5 Participants
|
2165 Participants
n=7 Participants
|
2160 Participants
n=5 Participants
|
2162 Participants
n=4 Participants
|
8659 Participants
n=21 Participants
|
|
Duration of diabetes (years)
≥6 <13 yr
|
1484 Participants
n=5 Participants
|
1492 Participants
n=7 Participants
|
1496 Participants
n=5 Participants
|
1493 Participants
n=4 Participants
|
5965 Participants
n=21 Participants
|
|
Duration of diabetes (years)
≥13 yr
|
214 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
856 Participants
n=21 Participants
|
|
Duration of diabetes (years)
|
7 years
n=5 Participants
|
7 years
n=7 Participants
|
7 years
n=5 Participants
|
7 years
n=4 Participants
|
7 years
n=21 Participants
|
|
Systolic blood pressure (mmHg)
<130 mmHg
|
849 Participants
n=5 Participants
|
845 Participants
n=7 Participants
|
846 Participants
n=5 Participants
|
854 Participants
n=4 Participants
|
3394 Participants
n=21 Participants
|
|
Systolic blood pressure (mmHg)
≥130 to <140 mmHg
|
764 Participants
n=5 Participants
|
786 Participants
n=7 Participants
|
783 Participants
n=5 Participants
|
758 Participants
n=4 Participants
|
3091 Participants
n=21 Participants
|
|
Systolic blood pressure (mmHg)
≥140 mmHg
|
1140 Participants
n=5 Participants
|
1123 Participants
n=7 Participants
|
1139 Participants
n=5 Participants
|
1153 Participants
n=4 Participants
|
4555 Participants
n=21 Participants
|
|
Systolic blood pressure (mmHg)
Unknown
|
1117 Participants
n=5 Participants
|
1116 Participants
n=7 Participants
|
1102 Participants
n=5 Participants
|
1105 Participants
n=4 Participants
|
4440 Participants
n=21 Participants
|
|
Systolic blood pressure (mean)
|
136.1 mmHg
STANDARD_DEVIATION 15.4 • n=5 Participants
|
136.1 mmHg
STANDARD_DEVIATION 15.0 • n=7 Participants
|
136.2 mmHg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
136.2 mmHg
STANDARD_DEVIATION 15.2 • n=4 Participants
|
136.2 mmHg
STANDARD_DEVIATION 15.3 • n=21 Participants
|
|
Vascular risk score
Low (<5%)
|
1567 Participants
n=5 Participants
|
1561 Participants
n=7 Participants
|
1577 Participants
n=5 Participants
|
1559 Participants
n=4 Participants
|
6264 Participants
n=21 Participants
|
|
Vascular risk score
Moderate (≥5%, <10%)
|
1635 Participants
n=5 Participants
|
1659 Participants
n=7 Participants
|
1634 Participants
n=5 Participants
|
1620 Participants
n=4 Participants
|
6548 Participants
n=21 Participants
|
|
Vascular risk score
High (≥10%)
|
668 Participants
n=5 Participants
|
650 Participants
n=7 Participants
|
659 Participants
n=5 Participants
|
691 Participants
n=4 Participants
|
2668 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsThe primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision \[ICD-10\] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage \[I60\], intracerebral hemorrhage \[I61\], and other non-traumatic intracranial hemorrhage \[I62\]).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)
|
658 Participants
|
743 Participants
|
689 Participants
|
712 Participants
|
PRIMARY outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsThe primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as: * any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or * sight-threatening eye bleeding; or * any other serious bleeding episode.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)
|
314 Participants
|
245 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsPopulation: A single participant may have had multiple events.
Secondary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 versus placebo on the first occurrence of the expanded vascular endpoint of "SVE or revascularization" (including coronary and non-coronary revascularizations).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Combined End-point of Serious Vascular Events (SVEs) or Revascularizations
|
833 Participants
|
936 Participants
|
882 Participants
|
887 Participants
|
SECONDARY outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsPopulation: Participants taking aspirin
Secondary efficacy assessments of aspirin involve intention-to-treat comparisons during the scheduled treatment period among all randomized participants on the first occurrence of: Any incident gastrointestinal (GI) tract cancer (i.e. any GI cancer excluding pancreas and hepatobiliary), overall and after exclusion of the first three years of follow-up.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Any Incident Gastrointestinal (GI) Tract Cancer (Aspirin Comparison Only)
|
157 Participants
|
158 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 years'All-cause mortality' includes all recorded deaths.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: All-cause Mortality
|
748 Participants
|
792 Participants
|
752 Participants
|
788 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'Coronary' events include deaths from: Acute MI and other CHD (unspecified Acute ischaemic heart disease; Atherosclerotic heart disease; Ischaemic cardiomyopathy; unspecified Chronic ischaemic heart disease).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Coronary
|
105 Participants
|
122 Participants
|
100 Participants
|
127 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'All stroke' events include deaths from: Haemorrhagic stroke (Intracerebral haemorrhage; Subarachnoid haemorrhage); Non-haemorrhagic stroke (Cerebral infarction; Stroke not specified as haemorrhage or infarction).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: All Stroke
|
38 Participants
|
34 Participants
|
35 Participants
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'Other vascular' events include deaths from: Heart failure (excluding ischaemic cardiomyopathy); Other vascular death (excluding stroke; and Cardiac death (excluding CHD).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Other Vascular
|
67 Participants
|
70 Participants
|
61 Participants
|
76 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'Cancer' events include any death attributed to cancer.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Cancer
|
309 Participants
|
315 Participants
|
305 Participants
|
319 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'Respiratory' events include any death attributed to respiratory causes.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Respiratory
|
82 Participants
|
69 Participants
|
73 Participants
|
78 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'Other medical' events include deaths from: Non-vascular medical causes (excluding cancer and respiratory, including Fatal GI bleed or perforation); and deaths from Renal disease and Diabetes.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Other Medical
|
126 Participants
|
157 Participants
|
158 Participants
|
125 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsFatal 'External cause' events include deaths from: Injury; Fracture; Self harm; and Medical and surgical complications
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: External Cause
|
18 Participants
|
21 Participants
|
17 Participants
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsAny death for which the cause is not known.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Fatal Event: Unknown Cause
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncidence of fatal or non-fatal cancers. Any cancer excludes non-fatal non-melanoma skin cancer and non-fatal recurrence of a cancer that had occurred before randomization. A single participant may have had multiple cancers.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Any Cancer
|
897 Participants
|
887 Participants
|
894 Participants
|
890 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers. Excludes cancers reported in the gastrointestinal tract category (see secondary outcome measure #4), and includes hepatobiliary and pancreatic cancers.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Other Gastrointestinal Cancer (Aspirin Comparison Only)
|
87 Participants
|
82 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers. Includes lung and larynx cancer.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Respiratory Cancer
|
101 Participants
|
103 Participants
|
104 Participants
|
100 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal renal, bladder, prostate, gynaecological and other GU cancers
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Genitourinary Cancer
|
332 Participants
|
294 Participants
|
323 Participants
|
303 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers. Includes leukaemia and lymphoma.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Hematological Cancer
|
88 Participants
|
86 Participants
|
94 Participants
|
80 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Breast Cancer
|
97 Participants
|
96 Participants
|
103 Participants
|
90 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal melanomas.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Melanoma
|
50 Participants
|
59 Participants
|
55 Participants
|
54 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers not included elsewhere (where the type of cancer is known).
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Other Cancer
|
25 Participants
|
30 Participants
|
23 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal cancers of unknown type.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 Participants
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 Participants
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Unspecified Cancer
|
26 Participants
|
31 Participants
|
25 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal events.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Atrial Fibrillation (Omega-3 Comparison Only)
|
166 Participants
|
135 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomized treatment phase during a mean of 7.4 yearsIncludes fatal and non-fatal events, excludes atrial fibrillation.
Outcome measures
| Measure |
Aspirin
n=7740 Participants
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 Participants
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Number of Participants With Event: Other Arrhythmia (Omega-3 Comparison Only)
|
83 Participants
|
99 Participants
|
—
|
—
|
Adverse Events
Aspirin
Serious events: 5264 serious events
Other events: 0 other events
Deaths: 748 deaths
Placebo Aspirin
Serious events: 5321 serious events
Other events: 0 other events
Deaths: 792 deaths
Omega-3
Serious events: 5344 serious events
Other events: 0 other events
Deaths: 752 deaths
Placebo Omega-3
Serious events: 5241 serious events
Other events: 0 other events
Deaths: 788 deaths
Serious adverse events
| Measure |
Aspirin
n=7740 participants at risk
Group includes 3870 participants in the Aspirin+Omega-3 arm, and 3870 participants in the Aspirin+Placebo Omega-3 arm
|
Placebo Aspirin
n=7740 participants at risk
Group includes 3870 participants in the Placebo Aspirin+Omega-3 arm, and 3870 participants in the Placebo Aspirin+Placebo Omega-3 arm
|
Omega-3
n=7740 participants at risk
Group includes 3870 participants in the Omega-3+Aspirin arm, and 3870 participants in the Omega-3+Placebo Aspirin arm
|
Placebo Omega-3
n=7740 participants at risk
Group includes 3870 participants in the Placebo Omega-3+Aspirin arm, and 3870 participants in the Placebo Omega-3+Placebo Aspirin arm
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.4%
184/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.9%
145/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.0%
156/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.2%
173/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Cardiac disorders
Cardiac disorders
|
10.1%
784/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.6%
824/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.5%
812/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.3%
796/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
0.06%
5/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.05%
4/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.08%
6/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.04%
3/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.57%
44/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.19%
15/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.30%
23/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.47%
36/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Endocrine disorders
Endocrine disorders
|
0.27%
21/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.27%
21/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.31%
24/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.23%
18/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Eye disorders
Eye disorders
|
6.6%
511/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
5.9%
457/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
6.3%
486/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
6.2%
482/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
8.6%
664/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
8.2%
635/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
8.7%
671/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
8.1%
628/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
General disorders
General disorders and administration site conditions
|
3.1%
240/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
3.0%
231/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
3.2%
247/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.9%
224/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.4%
112/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.9%
149/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.7%
134/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.6%
127/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Immune system disorders
Immune system disorders
|
0.35%
27/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.25%
19/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.21%
16/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.39%
30/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Infections and infestations
Infections and infestations
|
11.1%
859/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.4%
804/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.9%
847/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.5%
816/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
6.3%
484/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
6.2%
479/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
6.3%
488/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
6.1%
475/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Investigations
Investigations
|
11.7%
906/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
12.5%
965/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
12.1%
935/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
12.1%
936/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
2.6%
200/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.3%
176/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.6%
201/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.3%
175/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
3.2%
248/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
3.3%
256/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
3.4%
265/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
3.1%
239/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
17.1%
1320/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
16.4%
1266/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
16.7%
1294/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
16.7%
1292/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Nervous system disorders
Nervous system disorders
|
9.4%
724/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
10.0%
776/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
9.6%
741/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
9.8%
759/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.45%
35/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.53%
41/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.47%
36/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.52%
40/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
4.9%
381/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
5.0%
384/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
5.0%
387/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
4.9%
378/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
2.0%
157/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.7%
130/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.8%
137/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.9%
150/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
5.6%
436/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
4.5%
351/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
5.1%
395/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
5.1%
392/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
2.2%
171/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.6%
127/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
1.7%
131/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.2%
167/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Social circumstances
Social circumstances
|
0.03%
2/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.03%
2/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.04%
3/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
0.01%
1/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
37.7%
2916/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
38.6%
2990/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
38.6%
2990/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
37.7%
2916/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
|
Vascular disorders
Vascular disorders
|
2.5%
192/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.8%
213/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.5%
194/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
2.7%
211/7740 • Randomized treatment phase during a mean of 7.4 years
Follow-up questionnaires asking about cardiovascular events and other Serious Adverse Events were sent to participants at 6-monthly intervals. Only information about Serious Adverse Events were collected, therefore there are no Non-Serious Adverse Events to report.
|
Other adverse events
Adverse event data not reported
Additional Information
Prof Jane Armitage
Nuffield Department of Population Health
Phone: +44 (0)1865 743743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place