Trial Outcomes & Findings for S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (NCT NCT00706121)
NCT ID: NCT00706121
Last Updated: 2019-12-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
8094 participants
Primary outcome timeframe
From 1 year post randomization through study completion
Results posted on
2019-12-16
Participant Flow
Participant milestones
| Measure |
Vitamin E + Selenium Placebo
Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
Selenium + Vitamin E Placebo
Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
|
Vitamin E + Selenium
Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
|
Vitamin E Placebo + Selenium Placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2039
|
2096
|
2030
|
1929
|
|
Overall Study
COMPLETED
|
1643
|
1700
|
1626
|
1577
|
|
Overall Study
NOT COMPLETED
|
396
|
396
|
404
|
352
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects missing FDR information excluded.
Baseline characteristics by cohort
| Measure |
Vitamin E + Selenium Placebo
n=1643 Participants
Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
Selenium + Vitamin E Placebo
n=1700 Participants
Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
|
Vitamin E + Selenium
n=1626 Participants
Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
|
Vitamin E Placebo + Selenium Placebo
n=1577 Participants
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
Total
n=6546 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
n=1643 Participants
|
62.0 years
n=1700 Participants
|
62.0 years
n=1626 Participants
|
62.0 years
n=1577 Participants
|
62.0 years
n=6546 Participants
|
|
Age, Customized
Age, Categorical · 50-54
|
60 Participants
n=1643 Participants
|
59 Participants
n=1700 Participants
|
49 Participants
n=1626 Participants
|
52 Participants
n=1577 Participants
|
220 Participants
n=6546 Participants
|
|
Age, Customized
Age, Categorical · 55-64
|
1025 Participants
n=1643 Participants
|
1045 Participants
n=1700 Participants
|
1002 Participants
n=1626 Participants
|
933 Participants
n=1577 Participants
|
4005 Participants
n=6546 Participants
|
|
Age, Customized
Age, Categorical · 65-74
|
494 Participants
n=1643 Participants
|
538 Participants
n=1700 Participants
|
516 Participants
n=1626 Participants
|
524 Participants
n=1577 Participants
|
2072 Participants
n=6546 Participants
|
|
Age, Customized
Age, Categorical · >= 75
|
64 Participants
n=1643 Participants
|
58 Participants
n=1700 Participants
|
59 Participants
n=1626 Participants
|
68 Participants
n=1577 Participants
|
249 Participants
n=6546 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1643 Participants
|
0 Participants
n=1700 Participants
|
0 Participants
n=1626 Participants
|
0 Participants
n=1577 Participants
|
0 Participants
n=6546 Participants
|
|
Sex: Female, Male
Male
|
1643 Participants
n=1643 Participants
|
1700 Participants
n=1700 Participants
|
1626 Participants
n=1626 Participants
|
1577 Participants
n=1577 Participants
|
6546 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
1411 Participants
n=1643 Participants
|
1445 Participants
n=1700 Participants
|
1412 Participants
n=1626 Participants
|
1374 Participants
n=1577 Participants
|
5642 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · African American
|
181 Participants
n=1643 Participants
|
187 Participants
n=1700 Participants
|
167 Participants
n=1626 Participants
|
160 Participants
n=1577 Participants
|
695 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic, not African American
|
30 Participants
n=1643 Participants
|
30 Participants
n=1700 Participants
|
32 Participants
n=1626 Participants
|
25 Participants
n=1577 Participants
|
117 Participants
n=6546 Participants
|
|
Number of First Degree Relatives with Colorectal Cancer
1
|
185 Participants
n=1560 Participants • Subjects missing FDR information excluded.
|
198 Participants
n=1617 Participants • Subjects missing FDR information excluded.
|
181 Participants
n=1554 Participants • Subjects missing FDR information excluded.
|
196 Participants
n=1501 Participants • Subjects missing FDR information excluded.
|
760 Participants
n=6232 Participants • Subjects missing FDR information excluded.
|
|
Number of First Degree Relatives with Colorectal Cancer
2 or more
|
28 Participants
n=1560 Participants • Subjects missing FDR information excluded.
|
26 Participants
n=1617 Participants • Subjects missing FDR information excluded.
|
23 Participants
n=1554 Participants • Subjects missing FDR information excluded.
|
26 Participants
n=1501 Participants • Subjects missing FDR information excluded.
|
103 Participants
n=6232 Participants • Subjects missing FDR information excluded.
|
|
Medication Use -- Cox II Inhibitors
|
91 Participants
n=1641 Participants • Subjects missing information on Cox II inhibitor use excluded.
|
85 Participants
n=1697 Participants • Subjects missing information on Cox II inhibitor use excluded.
|
92 Participants
n=1624 Participants • Subjects missing information on Cox II inhibitor use excluded.
|
77 Participants
n=1575 Participants • Subjects missing information on Cox II inhibitor use excluded.
|
345 Participants
n=6537 Participants • Subjects missing information on Cox II inhibitor use excluded.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic, African American
|
2 Participants
n=1643 Participants
|
1 Participants
n=1700 Participants
|
1 Participants
n=1626 Participants
|
0 Participants
n=1577 Participants
|
4 Participants
n=6546 Participants
|
|
Medication Use -- Aspirin
|
756 Participants
n=1643 Participants
|
769 Participants
n=1700 Participants
|
775 Participants
n=1626 Participants
|
736 Participants
n=1577 Participants
|
3036 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Aboriginal
|
2 Participants
n=1643 Participants
|
8 Participants
n=1700 Participants
|
1 Participants
n=1626 Participants
|
7 Participants
n=1577 Participants
|
18 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian/Pacific Islander
|
12 Participants
n=1643 Participants
|
22 Participants
n=1700 Participants
|
11 Participants
n=1626 Participants
|
9 Participants
n=1577 Participants
|
54 Participants
n=6546 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
5 Participants
n=1643 Participants
|
7 Participants
n=1700 Participants
|
2 Participants
n=1626 Participants
|
2 Participants
n=1577 Participants
|
16 Participants
n=6546 Participants
|
|
Education
<=High school/GED
|
263 Participants
n=1639 Participants • Subjects missing education information excluded.
|
264 Participants
n=1691 Participants • Subjects missing education information excluded.
|
226 Participants
n=1615 Participants • Subjects missing education information excluded.
|
263 Participants
n=1572 Participants • Subjects missing education information excluded.
|
1016 Participants
n=6517 Participants • Subjects missing education information excluded.
|
|
Education
Some college/vocational
|
432 Participants
n=1639 Participants • Subjects missing education information excluded.
|
447 Participants
n=1691 Participants • Subjects missing education information excluded.
|
397 Participants
n=1615 Participants • Subjects missing education information excluded.
|
378 Participants
n=1572 Participants • Subjects missing education information excluded.
|
1654 Participants
n=6517 Participants • Subjects missing education information excluded.
|
|
Education
>=College graduate
|
944 Participants
n=1639 Participants • Subjects missing education information excluded.
|
980 Participants
n=1691 Participants • Subjects missing education information excluded.
|
992 Participants
n=1615 Participants • Subjects missing education information excluded.
|
931 Participants
n=1572 Participants • Subjects missing education information excluded.
|
3847 Participants
n=6517 Participants • Subjects missing education information excluded.
|
|
Smoking Status
Never
|
729 Participants
n=1642 Participants • Subjects missing smoking history excluded.
|
785 Participants
n=1698 Participants • Subjects missing smoking history excluded.
|
726 Participants
n=1625 Participants • Subjects missing smoking history excluded.
|
711 Participants
n=1575 Participants • Subjects missing smoking history excluded.
|
2951 Participants
n=6540 Participants • Subjects missing smoking history excluded.
|
|
Smoking Status
Current
|
87 Participants
n=1642 Participants • Subjects missing smoking history excluded.
|
98 Participants
n=1698 Participants • Subjects missing smoking history excluded.
|
99 Participants
n=1625 Participants • Subjects missing smoking history excluded.
|
97 Participants
n=1575 Participants • Subjects missing smoking history excluded.
|
381 Participants
n=6540 Participants • Subjects missing smoking history excluded.
|
|
Smoking Status
Former
|
826 Participants
n=1642 Participants • Subjects missing smoking history excluded.
|
815 Participants
n=1698 Participants • Subjects missing smoking history excluded.
|
800 Participants
n=1625 Participants • Subjects missing smoking history excluded.
|
767 Participants
n=1575 Participants • Subjects missing smoking history excluded.
|
3208 Participants
n=6540 Participants • Subjects missing smoking history excluded.
|
|
BMI, Categorical
Normal or underweight (<=25)
|
293 Participants
n=1639 Participants • Subjects missing BMI excluded.
|
355 Participants
n=1695 Participants • Subjects missing BMI excluded.
|
327 Participants
n=1619 Participants • Subjects missing BMI excluded.
|
324 Participants
n=1572 Participants • Subjects missing BMI excluded.
|
1299 Participants
n=6525 Participants • Subjects missing BMI excluded.
|
|
BMI, Categorical
Overweight (>25 to 30)
|
818 Participants
n=1639 Participants • Subjects missing BMI excluded.
|
795 Participants
n=1695 Participants • Subjects missing BMI excluded.
|
800 Participants
n=1619 Participants • Subjects missing BMI excluded.
|
764 Participants
n=1572 Participants • Subjects missing BMI excluded.
|
3177 Participants
n=6525 Participants • Subjects missing BMI excluded.
|
|
BMI, Categorical
Obese (>30)
|
528 Participants
n=1639 Participants • Subjects missing BMI excluded.
|
545 Participants
n=1695 Participants • Subjects missing BMI excluded.
|
492 Participants
n=1619 Participants • Subjects missing BMI excluded.
|
484 Participants
n=1572 Participants • Subjects missing BMI excluded.
|
2049 Participants
n=6525 Participants • Subjects missing BMI excluded.
|
|
BMI, Continuous
|
27.8 kg/m^2
n=1639 Participants • Subjects missing BMI excluded.
|
28.0 kg/m^2
n=1695 Participants • Subjects missing BMI excluded.
|
27.8 kg/m^2
n=1619 Participants • Subjects missing BMI excluded.
|
28.0 kg/m^2
n=1572 Participants • Subjects missing BMI excluded.
|
27.9 kg/m^2
n=6525 Participants • Subjects missing BMI excluded.
|
|
History of Cancer
|
38 Participants
n=1643 Participants
|
32 Participants
n=1700 Participants
|
35 Participants
n=1626 Participants
|
30 Participants
n=1577 Participants
|
135 Participants
n=6546 Participants
|
|
History of Colorectal Cancer
|
7 Participants
n=1643 Participants
|
7 Participants
n=1700 Participants
|
7 Participants
n=1626 Participants
|
5 Participants
n=1577 Participants
|
26 Participants
n=6546 Participants
|
|
History of Colon Polyps
|
355 Participants
n=1643 Participants
|
347 Participants
n=1700 Participants
|
339 Participants
n=1626 Participants
|
355 Participants
n=1577 Participants
|
1396 Participants
n=6546 Participants
|
|
History of Diverticulitis
|
128 Participants
n=1643 Participants
|
103 Participants
n=1700 Participants
|
121 Participants
n=1626 Participants
|
110 Participants
n=1577 Participants
|
462 Participants
n=6546 Participants
|
|
History of Diabetes
|
138 Participants
n=1643 Participants
|
126 Participants
n=1700 Participants
|
126 Participants
n=1626 Participants
|
148 Participants
n=1577 Participants
|
538 Participants
n=6546 Participants
|
|
Number of First Degree Relatives with Colorectal Cancer
0
|
1347 Participants
n=1560 Participants • Subjects missing FDR information excluded.
|
1393 Participants
n=1617 Participants • Subjects missing FDR information excluded.
|
1350 Participants
n=1554 Participants • Subjects missing FDR information excluded.
|
1279 Participants
n=1501 Participants • Subjects missing FDR information excluded.
|
5369 Participants
n=6232 Participants • Subjects missing FDR information excluded.
|
|
Medication Use -- Other NSAIDs
|
173 Participants
n=1641 Participants • Subjects missing information on NSAID use excluded.
|
175 Participants
n=1698 Participants • Subjects missing information on NSAID use excluded.
|
164 Participants
n=1626 Participants • Subjects missing information on NSAID use excluded.
|
168 Participants
n=1576 Participants • Subjects missing information on NSAID use excluded.
|
680 Participants
n=6541 Participants • Subjects missing information on NSAID use excluded.
|
|
Medication Use -- Statins
|
280 Participants
n=992 Participants • Subjects missing information on or not asked about statin use excluded.
|
297 Participants
n=1050 Participants • Subjects missing information on or not asked about statin use excluded.
|
283 Participants
n=1005 Participants • Subjects missing information on or not asked about statin use excluded.
|
284 Participants
n=955 Participants • Subjects missing information on or not asked about statin use excluded.
|
1144 Participants
n=4002 Participants • Subjects missing information on or not asked about statin use excluded.
|
PRIMARY outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
Outcome measures
| Measure |
Active Selenium
n=3326 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=3220 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
|
1136 Participants
|
1150 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
Adenomas with diameter \>=1cm or any adenoma with villous features or high-grade dysplasia
Outcome measures
| Measure |
Active Selenium
n=3326 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=3220 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
|
269 Participants
|
282 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From 1 year post randomization through study completionOutcome measures
| Measure |
Active Selenium
n=1643 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=1700 Participants
Selenium Placebo +/- Vitamin E
|
Combination
n=1626 Participants
Vitamin E + selenium
|
Placebo
n=1577 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
|
10 Participants
|
11 Participants
|
9 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
Outcome measures
| Measure |
Active Selenium
n=3326 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=3220 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect of Selenium on Occurrences of Multiple (>2) Adenomas
|
258 Participants
|
276 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
Outcome measures
| Measure |
Active Selenium
n=3269 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=3277 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo
|
1159 Participants
|
1127 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
Outcome measures
| Measure |
Active Selenium
n=1133 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=1146 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Normal
|
30.2 percentage of participants
|
31.4 percentage of participants
|
—
|
—
|
|
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Overweight
|
35.2 percentage of participants
|
36.5 percentage of participants
|
—
|
—
|
|
Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Obese
|
35.2 percentage of participants
|
37.0 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.
Outcome measures
| Measure |
Active Selenium
n=1136 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=1150 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Users
|
33.5 ercentage of participants in subgroup
|
36.4 ercentage of participants in subgroup
|
—
|
—
|
|
Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
Non-users
|
34.9 ercentage of participants in subgroup
|
34.9 ercentage of participants in subgroup
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
Outcome measures
| Measure |
Active Selenium
n=1155 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=1124 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Normal
|
30.2 ercentage of participants in subgroup
|
31.4 ercentage of participants in subgroup
|
—
|
—
|
|
Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Overweight
|
36.8 ercentage of participants in subgroup
|
34.9 ercentage of participants in subgroup
|
—
|
—
|
|
Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Obese
|
36.5 ercentage of participants in subgroup
|
35.7 ercentage of participants in subgroup
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 1 year post randomization through study completionPopulation: Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.
Outcome measures
| Measure |
Active Selenium
n=1159 Participants
Active Selenium +/- Vitamin E
|
Selenium Placebo
n=1127 Participants
Selenium Placebo +/- Vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Users
|
34.5 ercentage of participants in subgroup
|
35.3 ercentage of participants in subgroup
|
—
|
—
|
|
Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo
Non-users
|
36.5 ercentage of participants in subgroup
|
33.3 ercentage of participants in subgroup
|
—
|
—
|
Adverse Events
Vitamin E + Selenium Placebo
Serious events: 10 serious events
Other events: 116 other events
Deaths: 0 deaths
Selenium + Vitamin E Placebo
Serious events: 12 serious events
Other events: 85 other events
Deaths: 0 deaths
Vitamin E + Selenium
Serious events: 14 serious events
Other events: 112 other events
Deaths: 0 deaths
Vitamin E Placebo + Selenium Placebo
Serious events: 19 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin E + Selenium Placebo
n=1643 participants at risk
Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
Selenium + Vitamin E Placebo
n=1700 participants at risk
Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
|
Vitamin E + Selenium
n=1626 participants at risk
Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
|
Vitamin E Placebo + Selenium Placebo
n=1577 participants at risk
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.12%
2/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.29%
5/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.43%
7/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.38%
6/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Cardiac disorders
Cardiovascular-other
|
0.18%
3/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.18%
3/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.37%
6/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.38%
6/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Cardiac disorders
Supraventricular arrhythmia
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.06%
1/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Injury, poisoning and procedural complications
Surgery-hemorrhage
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Investigations
Weight gain
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Nervous system disorders
CNS hemorrhage
|
0.06%
1/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.12%
2/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.12%
2/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.18%
3/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.13%
2/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Reproductive system and breast disorders
Erectile impotence
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
1/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Vascular disorders
Carotid stenosis
|
0.06%
1/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Vascular disorders
Peripheral arterial ischemia
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.00%
0/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
0.06%
1/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
Other adverse events
| Measure |
Vitamin E + Selenium Placebo
n=1643 participants at risk
Vitamin E and selenium placebo daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
Selenium + Vitamin E Placebo
n=1700 participants at risk
Selenium and vitamin E placebo daily for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
|
Vitamin E + Selenium
n=1626 participants at risk
Vitamin E and selenium daily for 7 - 12 years
Vitamin E: 400 IU daily by mouth for 7 - 12 years
Selenium: 200 mcg daily for 7 - 12 years
|
Vitamin E Placebo + Selenium Placebo
n=1577 participants at risk
Vitamin E placebo and selenium placebo daily for 7 - 12 years
Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years
selenium placebo: 1 pill by mouth daily for 7 - 12 years
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
7.1%
116/1643 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
5.0%
85/1700 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
6.9%
112/1626 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
6.3%
100/1577 • Every 6 months while the participant is receiving study supplements.
There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
|
Additional Information
SELECT/S0000D Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60