Trial Outcomes & Findings for S0000 Selenium and Vitamin E in Preventing Prostate Cancer (NCT NCT00006392)
NCT ID: NCT00006392
Last Updated: 2015-11-20
Results Overview
Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35533 participants
Primary outcome timeframe
Every six months for 7 to 12 years depending on when the participant was randomized.
Results posted on
2015-11-20
Participant Flow
Men were randomized at 427 study sites in the US, Puerto Rico and Canada between August 22, 2001 and June 24, 2004.
Prior to randomization, there was a three month formal pre-randomization period with no placebo run-in capsules to give potential participants to decide if they would agree to stop disallowed over-the-counter supplements of selenium or vitamin E. By returning for randomization, they exhibited their willingness to adhere to the trial.
Participant milestones
| Measure |
Vitamin E
Vitamin E + matching placebo for selenium
|
Selenium
Selenium + matching placebo for vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8904
|
8910
|
8863
|
8856
|
|
Overall Study
COMPLETED
|
8737
|
8752
|
8703
|
8696
|
|
Overall Study
NOT COMPLETED
|
167
|
158
|
160
|
160
|
Reasons for withdrawal
| Measure |
Vitamin E
Vitamin E + matching placebo for selenium
|
Selenium
Selenium + matching placebo for vitamin E
|
Combination
Vitamin E + selenium
|
Placebo
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Overall Study
Ineligible
|
11
|
3
|
5
|
5
|
|
Overall Study
Poor data/ppt mgmt, regulatory problems
|
156
|
155
|
155
|
155
|
Baseline Characteristics
S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Baseline characteristics by cohort
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
Total
n=34888 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.4 years
n=99 Participants
|
62.6 years
n=107 Participants
|
62.3 years
n=206 Participants
|
62.6 years
n=7 Participants
|
62.3 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8737 Participants
n=99 Participants
|
8752 Participants
n=107 Participants
|
8703 Participants
n=206 Participants
|
8696 Participants
n=7 Participants
|
34888 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
6890 Participant
n=99 Participants
|
6942 Participant
n=107 Participants
|
6874 Participant
n=206 Participants
|
6863 Participant
n=7 Participants
|
27569 Participant
n=31 Participants
|
|
Race/Ethnicity, Customized
African American
|
1107 Participant
n=99 Participants
|
1053 Participant
n=107 Participants
|
1076 Participant
n=206 Participants
|
1078 Participant
n=7 Participants
|
4314 Participant
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic (non-African American)
|
477 Participant
n=99 Participants
|
481 Participant
n=107 Participants
|
484 Participant
n=206 Participants
|
492 Participant
n=7 Participants
|
1934 Participant
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic (African American)
|
103 Participant
n=99 Participants
|
86 Participant
n=107 Participants
|
95 Participant
n=206 Participants
|
76 Participant
n=7 Participants
|
360 Participant
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
160 Participant
n=99 Participants
|
190 Participant
n=107 Participants
|
174 Participant
n=206 Participants
|
187 Participant
n=7 Participants
|
711 Participant
n=31 Participants
|
|
Region of Enrollment
United States
|
7463 participants
n=99 Participants
|
7471 participants
n=107 Participants
|
7427 participants
n=206 Participants
|
7428 participants
n=7 Participants
|
29789 participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
909 participants
n=99 Participants
|
915 participants
n=107 Participants
|
911 participants
n=206 Participants
|
904 participants
n=7 Participants
|
3639 participants
n=31 Participants
|
|
Region of Enrollment
Puerto Rico
|
365 participants
n=99 Participants
|
366 participants
n=107 Participants
|
365 participants
n=206 Participants
|
364 participants
n=7 Participants
|
1460 participants
n=31 Participants
|
|
Age (categorical)
50 - 54 years
|
402 participants
n=99 Participants
|
337 participants
n=107 Participants
|
385 participants
n=206 Participants
|
355 participants
n=7 Participants
|
1479 participants
n=31 Participants
|
|
Age (categorical)
55 - 64 years
|
5143 participants
n=99 Participants
|
5076 participants
n=107 Participants
|
5052 participants
n=206 Participants
|
5078 participants
n=7 Participants
|
20349 participants
n=31 Participants
|
|
Age (categorical)
65 - 74 years
|
2641 participants
n=99 Participants
|
2733 participants
n=107 Participants
|
2731 participants
n=206 Participants
|
2702 participants
n=7 Participants
|
10807 participants
n=31 Participants
|
|
Age (categorical)
>= 75 years
|
551 participants
n=99 Participants
|
606 participants
n=107 Participants
|
535 participants
n=206 Participants
|
561 participants
n=7 Participants
|
2253 participants
n=31 Participants
|
|
Education (highest)
<= High school graduate or GED
|
1875 Participant
n=99 Participants
|
1917 Participant
n=107 Participants
|
1898 Participant
n=206 Participants
|
1993 Participant
n=7 Participants
|
7683 Participant
n=31 Participants
|
|
Education (highest)
Some college/vocational school
|
2387 Participant
n=99 Participants
|
2327 Participant
n=107 Participants
|
2348 Participant
n=206 Participants
|
2291 Participant
n=7 Participants
|
9353 Participant
n=31 Participants
|
|
Education (highest)
>= College graduate
|
4394 Participant
n=99 Participants
|
4430 Participant
n=107 Participants
|
4372 Participant
n=206 Participants
|
4317 Participant
n=7 Participants
|
17513 Participant
n=31 Participants
|
|
Education (highest)
Unknown/missing
|
81 Participant
n=99 Participants
|
78 Participant
n=107 Participants
|
85 Participant
n=206 Participants
|
95 Participant
n=7 Participants
|
339 Participant
n=31 Participants
|
|
PSA (ng/ml)
0.1 - 1.0
|
4208 Participant
n=99 Participants
|
4218 Participant
n=107 Participants
|
4213 Participant
n=206 Participants
|
4122 Participant
n=7 Participants
|
16761 Participant
n=31 Participants
|
|
PSA (ng/ml)
1.1 - 2.0
|
2653 Participant
n=99 Participants
|
2661 Participant
n=107 Participants
|
2666 Participant
n=206 Participants
|
2728 Participant
n=7 Participants
|
10708 Participant
n=31 Participants
|
|
PSA (ng/ml)
2.1 - 3.0
|
1228 Participant
n=99 Participants
|
1211 Participant
n=107 Participants
|
1149 Participant
n=206 Participants
|
1168 Participant
n=7 Participants
|
4756 Participant
n=31 Participants
|
|
PSA (ng/ml)
3.1 - 4.0
|
634 Participant
n=99 Participants
|
652 Participant
n=107 Participants
|
659 Participant
n=206 Participants
|
666 Participant
n=7 Participants
|
2611 Participant
n=31 Participants
|
|
PSA (ng/ml)
> 4.0
|
3 Participant
n=99 Participants
|
2 Participant
n=107 Participants
|
1 Participant
n=206 Participants
|
5 Participant
n=7 Participants
|
11 Participant
n=31 Participants
|
|
PSA (ng/ml)
Unknown/missing
|
11 Participant
n=99 Participants
|
8 Participant
n=107 Participants
|
15 Participant
n=206 Participants
|
7 Participant
n=7 Participants
|
41 Participant
n=31 Participants
|
|
Smoking status
Never
|
3752 Participant
n=99 Participants
|
3780 Participant
n=107 Participants
|
3666 Participant
n=206 Participants
|
3682 Participant
n=7 Participants
|
14880 Participant
n=31 Participants
|
|
Smoking status
Current
|
659 Participant
n=99 Participants
|
631 Participant
n=107 Participants
|
670 Participant
n=206 Participants
|
655 Participant
n=7 Participants
|
2615 Participant
n=31 Participants
|
|
Smoking status
Former
|
4194 Participant
n=99 Participants
|
4214 Participant
n=107 Participants
|
4242 Participant
n=206 Participants
|
4208 Participant
n=7 Participants
|
16858 Participant
n=31 Participants
|
|
Smoking status
Ever (unknown status)
|
55 Participant
n=99 Participants
|
61 Participant
n=107 Participants
|
56 Participant
n=206 Participants
|
63 Participant
n=7 Participants
|
235 Participant
n=31 Participants
|
|
Smoking status
Unknown
|
77 Participant
n=99 Participants
|
66 Participant
n=107 Participants
|
69 Participant
n=206 Participants
|
88 Participant
n=7 Participants
|
300 Participant
n=31 Participants
|
PRIMARY outcome
Timeframe: Every six months for 7 to 12 years depending on when the participant was randomized.Population: All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.
Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Number of Participants With Prostate Cancer
|
473 participants
|
432 participants
|
437 participants
|
416 participants
|
SECONDARY outcome
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.Population: All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.
Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Number of Participants With Lung Cancer
|
67 participants
|
75 participants
|
78 participants
|
67 participants
|
SECONDARY outcome
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.Population: All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.
Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Number of Participants With Colorectal Cancer
|
66 participants
|
63 participants
|
77 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.Population: All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.
Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Number of Participants With Any Diagnosis of Cancer
|
856 participants
|
837 participants
|
846 participants
|
824 participants
|
SECONDARY outcome
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.Population: All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.
Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
All deaths
|
358 participants
|
378 participants
|
359 participants
|
382 participants
|
|
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
All cancer deaths
|
106 participants
|
128 participants
|
117 participants
|
125 participants
|
|
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
Prostate cancer deaths
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
Lung cancer deaths
|
38 participants
|
45 participants
|
39 participants
|
41 participants
|
|
Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
Colorectal cancer deaths
|
13 participants
|
10 participants
|
15 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.Population: All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.
Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.
Outcome measures
| Measure |
Vitamin E
n=8737 Participants
Vitamin E + matching placebo for selenium
|
Selenium
n=8752 Participants
Selenium + matching placebo for vitamin E
|
Combination
n=8703 Participants
Vitamin E + selenium
|
Placebo
n=8696 Participants
Matching placebo for vitamin E + matching placebo for selenium
|
|---|---|---|---|---|
|
Number of Participants With Serious Cardiovascular Events
|
1034 participants
|
1080 participants
|
1041 participants
|
1050 participants
|
Adverse Events
Selenium Alone
Serious events: 96 serious events
Other events: 2605 other events
Deaths: 0 deaths
Combination
Serious events: 93 serious events
Other events: 2550 other events
Deaths: 0 deaths
Placebo
Serious events: 108 serious events
Other events: 2421 other events
Deaths: 0 deaths
Vitamin E Alone
Serious events: 99 serious events
Other events: 2553 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selenium Alone
n=8752 participants at risk
Selenium + placebo for vitamin E
|
Combination
n=8702 participants at risk
Selenium + vitamin E
|
Placebo
n=8696 participants at risk
Placebo for selenium + placebo for vitamin E
|
Vitamin E Alone
n=8737 participants at risk
Vitamin E + placebo for selenium
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia, NOS
|
0.03%
3/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.29%
25/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.30%
26/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.31%
27/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.21%
18/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
Cardiovascular-other
|
0.10%
9/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.14%
12/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.20%
17/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.16%
14/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
Conduction abnormality/block
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
LVEF decrease/CHF
|
0.10%
9/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.05%
4/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
Supraventricular arrhythmia
|
0.03%
3/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.03%
3/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
2/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.09%
8/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.03%
3/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Eye disorders
Eye-other
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Eye disorders
Vision,NOS
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Gastrointestinal disorders
GI-other
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Gastrointestinal disorders
Melena/ GI bleeding
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
General disorders
Constitutional symptoms-other
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
General disorders
Hemorrhage w/o 3-4 thrombocyt
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
General disorders
Pain-other
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
General disorders
Reportable adverse event, NOS
|
0.13%
11/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.11%
10/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.20%
17/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.22%
19/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Hepatobiliary disorders
Liver-clinical
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Hepatobiliary disorders
Liver-other
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Infections and infestations
Respiratory infect w/o neutrop
|
0.02%
2/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Infections and infestations
Respiratory infection, unk ANC
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Infections and infestations
Urinary tr infect w/o neutrop
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Injury, poisoning and procedural complications
Surgery-hemorrhage
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Investigations
Weight gain
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia, NOS
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary
|
0.05%
4/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.06%
5/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.03%
3/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
CNS hemorrhage
|
0.09%
8/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.09%
8/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.03%
3/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.10%
9/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.08%
7/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.20%
17/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.11%
10/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.09%
8/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Cranial neuropathy
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Headache
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Neuro-other
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Seizures
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Sensory neuropathy
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Syncope
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Nervous system disorders
Tremor
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Renal and urinary disorders
Renal failure
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Renal and urinary disorders
Urinary retention
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Reproductive system and breast disorders
Erectile impotence
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema/COPD
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Aortic Stenosis
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Cardiomyopathy
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Carotid stenosis
|
0.00%
0/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Hypertension
|
0.02%
2/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Hypotension
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.00%
0/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Peripheral arterial ischemia
|
0.01%
1/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.01%
1/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Vascular disorders
Thrombosis/embolism
|
0.02%
2/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.02%
2/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.03%
3/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
0.05%
4/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
Other adverse events
| Measure |
Selenium Alone
n=8752 participants at risk
Selenium + placebo for vitamin E
|
Combination
n=8702 participants at risk
Selenium + vitamin E
|
Placebo
n=8696 participants at risk
Placebo for selenium + placebo for vitamin E
|
Vitamin E Alone
n=8737 participants at risk
Vitamin E + placebo for selenium
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
6.4%
558/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.1%
533/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.1%
529/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.3%
551/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Gastrointestinal disorders
Halitosis
|
6.0%
523/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.4%
555/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
5.1%
447/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
5.9%
517/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
General disorders
Fatigue/malaise/lethargy
|
8.0%
698/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
7.5%
657/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
7.3%
632/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
7.6%
660/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.4%
647/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.8%
593/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
6.4%
554/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
7.2%
627/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
12.9%
1129/8752 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
12.4%
1080/8702 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
12.3%
1072/8696 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
12.2%
1070/8737 • 6 months
Study site visits, collected by CRA based on participant interview and annual limited physical exam
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 2066674623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place