Trial Outcomes & Findings for A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline (NCT NCT01669915)
NCT ID: NCT01669915
Last Updated: 2023-04-21
Results Overview
We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3424 participants
Primary outcome timeframe
Change over two assessments (baseline, 2.8 years).
Results posted on
2023-04-21
Participant Flow
In this telephone interview ancillary study, participants (NCT01169259) who:1) were aged 60 or more; 2) had no hearing impairment; 3) were willing to participate in a cognitive sub-study (during run-in phase) were included.
Participant milestones
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
844
|
866
|
855
|
859
|
|
Overall Study
COMPLETED
|
844
|
866
|
855
|
859
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Baseline characteristics by cohort
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
n=844 Participants
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
n=866 Participants
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
n=855 Participants
PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
n=859 Participants
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
|
Total
n=3424 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
388 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
749 Participants
n=5 Participants
|
751 Participants
n=7 Participants
|
767 Participants
n=5 Participants
|
769 Participants
n=4 Participants
|
3036 Participants
n=21 Participants
|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
70.9 years
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
484 Participants
n=5 Participants
|
527 Participants
n=7 Participants
|
503 Participants
n=5 Participants
|
502 Participants
n=4 Participants
|
2016 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
360 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
1408 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic white
|
595 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
624 Participants
n=5 Participants
|
621 Participants
n=4 Participants
|
2429 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
178 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
743 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic (not African American)
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American/Alaskan Native
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/unknown
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
844 participants
n=5 Participants
|
866 participants
n=7 Participants
|
855 participants
n=5 Participants
|
859 participants
n=4 Participants
|
4218 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Change over two assessments (baseline, 2.8 years).We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
Outcome measures
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 Participants
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 Participants
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Change in Global Composite Score for Cognitive Decline
|
-0.24 Z-score
Standard Error 0.01
|
-0.25 Z-score
Standard Error 0.01
|
-0.25 Z-score
Standard Error 0.01
|
-0.24 Z-score
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Change over two assessments (baseline, 2.8 years)The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.
Outcome measures
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 Participants
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 Participants
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Change in Episodic Memory Score for Cognitive Decline
|
0.00 Z-score
Standard Error 0.02
|
-0.02 Z-score
Standard Error 0.02
|
-0.03 Z-score
Standard Error 0.02
|
0.02 Z-score
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Change over two assessments (baseline, 2.8 years)The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.
Outcome measures
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 Participants
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 Participants
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Change in Executive Function Score for Cognitive Decline
|
-0.48 Z-score
Standard Error 0.02
|
-0.48 Z-score
Standard Error 0.02
|
-0.47 Z-score
Standard Error 0.02
|
-0.49 Z-score
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Change over two assessments (baseline, 2.8 years)Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05
Outcome measures
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 Participants
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 Participants
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 Participants
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 Participants
Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|
|
Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
|
0.12 score on a scale
Standard Error 0.07
|
0.07 score on a scale
Standard Error 0.07
|
0.005 score on a scale
Standard Error 0.07
|
0.18 score on a scale
Standard Error 0.07
|
Adverse Events
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
Serious events: 138 serious events
Other events: 1259 other events
Deaths: 41 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
Serious events: 117 serious events
Other events: 1236 other events
Deaths: 26 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
Serious events: 134 serious events
Other events: 1220 other events
Deaths: 42 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
Serious events: 121 serious events
Other events: 1275 other events
Deaths: 25 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Active Omega-3 Fatty Acids
Serious events: 74 serious events
Other events: 600 other events
Deaths: 26 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Placebo Omega-3 Fatty Acids
Serious events: 64 serious events
Other events: 659 other events
Deaths: 15 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Active Omega-3 Fatty Acids
Serious events: 60 serious events
Other events: 620 other events
Deaths: 16 deaths
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Placebo Omega-3 Fatty Acids
Serious events: 57 serious events
Other events: 616 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 participants at risk
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 participants at risk
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 participants at risk
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 participants at risk
Omega-3 fatty acids placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Active Omega-3 Fatty Acids
n=844 participants at risk
Vitamin D3 (one 2000 IU capsule/day) + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Placebo Omega-3 Fatty Acids
n=866 participants at risk
Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Active Omega-3 Fatty Acids
n=855 participants at risk
Vitamin D placebo, one capsule/day + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Placebo Omega-3 Fatty Acids
n=859 participants at risk
Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Death
|
2.4%
41/1710 • Number of events 41
|
1.5%
26/1714 • Number of events 26
|
2.5%
42/1699 • Number of events 42
|
1.4%
25/1725 • Number of events 25
|
3.1%
26/844 • Number of events 26
|
1.7%
15/866 • Number of events 15
|
1.9%
16/855 • Number of events 16
|
1.2%
10/859 • Number of events 10
|
|
General disorders
Cancer
|
3.6%
62/1710 • Number of events 62
|
3.0%
51/1714 • Number of events 51
|
3.2%
54/1699 • Number of events 54
|
3.4%
59/1725 • Number of events 59
|
3.6%
30/844 • Number of events 30
|
3.7%
32/866 • Number of events 32
|
2.8%
24/855 • Number of events 24
|
3.1%
27/859 • Number of events 27
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
1.5%
25/1710 • Number of events 25
|
1.9%
33/1714 • Number of events 33
|
2.0%
34/1699 • Number of events 34
|
1.4%
24/1725 • Number of events 24
|
1.7%
14/844 • Number of events 14
|
1.3%
11/866 • Number of events 11
|
2.3%
20/855 • Number of events 20
|
1.5%
13/859 • Number of events 13
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.70%
12/1710 • Number of events 12
|
0.29%
5/1714 • Number of events 5
|
0.59%
10/1699 • Number of events 10
|
0.41%
7/1725 • Number of events 7
|
0.95%
8/844 • Number of events 8
|
0.46%
4/866 • Number of events 4
|
0.23%
2/855 • Number of events 2
|
0.35%
3/859 • Number of events 3
|
|
Cardiac disorders
Major cardiovascular event
|
2.2%
37/1710 • Number of events 37
|
1.3%
22/1714 • Number of events 22
|
2.1%
35/1699 • Number of events 35
|
1.4%
24/1725 • Number of events 24
|
2.8%
24/844 • Number of events 24
|
1.5%
13/866 • Number of events 13
|
1.3%
11/855 • Number of events 11
|
1.3%
11/859 • Number of events 11
|
Other adverse events
| Measure |
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D
n=1710 participants at risk
Vitamin D3, one 2000 IU capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo
n=1714 participants at risk
Vitamin D placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Omega-3 Fatty Acids
n=1699 participants at risk
Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo
n=1725 participants at risk
Omega-3 fatty acids placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Active Omega-3 Fatty Acids
n=844 participants at risk
Vitamin D3 (one 2000 IU capsule/day) + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Placebo Omega-3 Fatty Acids
n=866 participants at risk
Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Active Omega-3 Fatty Acids
n=855 participants at risk
Vitamin D placebo, one capsule/day + Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA).
|
TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Placebo Omega-3 Fatty Acids
n=859 participants at risk
Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Easy bruising
|
25.3%
432/1710 • Number of events 432
|
24.0%
411/1714 • Number of events 411
|
25.3%
429/1699 • Number of events 429
|
24.0%
414/1725 • Number of events 414
|
25.2%
213/844 • Number of events 213
|
25.3%
219/866 • Number of events 219
|
25.3%
216/855 • Number of events 216
|
22.7%
195/859 • Number of events 195
|
|
Blood and lymphatic system disorders
Frequent nosebleeds
|
2.5%
43/1710 • Number of events 43
|
3.3%
56/1714 • Number of events 56
|
2.9%
50/1699 • Number of events 50
|
2.8%
49/1725 • Number of events 49
|
2.7%
23/844 • Number of events 23
|
2.3%
20/866 • Number of events 20
|
3.2%
27/855 • Number of events 27
|
3.4%
29/859 • Number of events 29
|
|
Blood and lymphatic system disorders
Blood in urine
|
4.6%
79/1710 • Number of events 79
|
4.7%
81/1714 • Number of events 81
|
5.2%
88/1699 • Number of events 88
|
4.2%
72/1725 • Number of events 72
|
4.9%
41/844 • Number of events 41
|
4.4%
38/866 • Number of events 38
|
5.5%
47/855 • Number of events 47
|
4.0%
34/859 • Number of events 34
|
|
Endocrine disorders
Parathyroid condition
|
0.29%
5/1710 • Number of events 5
|
0.35%
6/1714 • Number of events 6
|
0.35%
6/1699 • Number of events 6
|
0.29%
5/1725 • Number of events 5
|
0.36%
3/844 • Number of events 3
|
0.23%
2/866 • Number of events 2
|
0.35%
3/855 • Number of events 3
|
0.35%
3/859 • Number of events 3
|
|
Gastrointestinal disorders
Stomach upset of pain
|
30.0%
513/1710 • Number of events 513
|
28.4%
487/1714 • Number of events 487
|
29.7%
505/1699 • Number of events 505
|
28.7%
495/1725 • Number of events 495
|
30.6%
258/844 • Number of events 258
|
29.4%
255/866 • Number of events 255
|
28.9%
247/855 • Number of events 247
|
27.9%
240/859 • Number of events 240
|
|
Gastrointestinal disorders
Nausea
|
20.8%
355/1710 • Number of events 355
|
20.2%
346/1714 • Number of events 346
|
21.4%
364/1699 • Number of events 364
|
19.5%
337/1725 • Number of events 337
|
21.6%
182/844 • Number of events 182
|
20.0%
173/866 • Number of events 173
|
21.3%
182/855 • Number of events 182
|
19.1%
164/859 • Number of events 164
|
|
Gastrointestinal disorders
Constipation
|
33.2%
568/1710 • Number of events 568
|
33.4%
573/1714 • Number of events 573
|
32.2%
547/1699 • Number of events 547
|
34.4%
594/1725 • Number of events 594
|
31.8%
268/844 • Number of events 268
|
34.6%
300/866 • Number of events 300
|
32.6%
279/855 • Number of events 279
|
34.2%
294/859 • Number of events 294
|
|
Gastrointestinal disorders
Diarrhea
|
33.6%
575/1710 • Number of events 575
|
35.0%
600/1714 • Number of events 600
|
34.4%
584/1699 • Number of events 584
|
34.3%
591/1725 • Number of events 591
|
33.9%
286/844 • Number of events 286
|
33.4%
289/866 • Number of events 289
|
34.9%
298/855 • Number of events 298
|
35.2%
302/859 • Number of events 302
|
|
Gastrointestinal disorders
Increased burping
|
13.4%
229/1710 • Number of events 229
|
14.6%
251/1714 • Number of events 251
|
14.1%
240/1699 • Number of events 240
|
13.9%
240/1725 • Number of events 240
|
12.9%
109/844 • Number of events 109
|
13.9%
120/866 • Number of events 120
|
15.3%
131/855 • Number of events 131
|
14.0%
120/859 • Number of events 120
|
|
General disorders
Bad taste in mouth
|
13.4%
229/1710 • Number of events 229
|
13.5%
231/1714 • Number of events 231
|
13.8%
234/1699 • Number of events 234
|
13.1%
226/1725 • Number of events 226
|
14.2%
120/844 • Number of events 120
|
12.6%
109/866 • Number of events 109
|
13.3%
114/855 • Number of events 114
|
13.6%
117/859 • Number of events 117
|
|
Renal and urinary disorders
Kidney stones
|
1.4%
24/1710 • Number of events 24
|
1.5%
25/1714 • Number of events 25
|
1.4%
24/1699 • Number of events 24
|
1.4%
25/1725 • Number of events 25
|
1.4%
12/844 • Number of events 12
|
1.4%
12/866 • Number of events 12
|
1.4%
12/855 • Number of events 12
|
1.5%
13/859 • Number of events 13
|
|
Renal and urinary disorders
Kidney failure or dialysis
|
0.64%
11/1710 • Number of events 11
|
0.47%
8/1714 • Number of events 8
|
0.53%
9/1699 • Number of events 9
|
0.58%
10/1725 • Number of events 10
|
0.71%
6/844 • Number of events 6
|
0.58%
5/866 • Number of events 5
|
0.35%
3/855 • Number of events 3
|
0.58%
5/859 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
20.6%
352/1710 • Number of events 352
|
21.1%
361/1714 • Number of events 361
|
20.2%
344/1699 • Number of events 344
|
21.4%
369/1725 • Number of events 369
|
19.5%
165/844 • Number of events 165
|
21.6%
187/866 • Number of events 187
|
20.9%
179/855 • Number of events 179
|
21.2%
182/859 • Number of events 182
|
Additional Information
Jae Hee Kang
Brigham and Women's Hospital;181 Longwood Ave; Boston, MA 02115
Phone: 617-525-2022
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place