Trial Outcomes & Findings for Vitamin D Supplementation in Multiple Sclerosis (NCT NCT01490502)
NCT ID: NCT01490502
Last Updated: 2022-09-28
Results Overview
Confirmed relapse defined as new or worsening symptoms referable to the central nervous system, lasting at least 24 hours, occurring at least 30 days since the prior attack, accompanied by worsening of the EDSS (\>= 0.5 points) or in the Functional Systems (FS) scales (2 points on at least one FS scale or 1 point on \>= two FS scales).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
2 years
Results posted on
2022-09-28
Participant Flow
Recruitment took place from March 2012 through April 2019 at 16 neurology clinics in the United States.
After successful screening, a thirty day run-in period was used to assess compliance with daily subcutaneous glatiramer acetate injections. Participants who missed more than 3 injections during the run-in period were ineligible to be randomized and were withdrawn from further study participation.
Participant milestones
| Measure |
Low-dose Vitamin D3
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
89
|
|
Overall Study
Received Allocated Intervention
|
83
|
88
|
|
Overall Study
Attended at Least 1 Follow-up Visit
|
82
|
83
|
|
Overall Study
COMPLETED
|
68
|
72
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
Baseline characteristics by cohort
| Measure |
Low-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=89 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 7.7 • n=83 Participants
|
34.5 years
STANDARD_DEVIATION 7.1 • n=89 Participants
|
34.4 years
STANDARD_DEVIATION 7.4 • n=172 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=83 Participants
|
61 Participants
n=89 Participants
|
131 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=83 Participants
|
28 Participants
n=89 Participants
|
41 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=83 Participants
|
18 Participants
n=89 Participants
|
30 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=83 Participants
|
71 Participants
n=89 Participants
|
141 Participants
n=172 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=83 Participants
|
1 Participants
n=89 Participants
|
2 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=83 Participants
|
11 Participants
n=89 Participants
|
29 Participants
n=172 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=83 Participants
|
71 Participants
n=89 Participants
|
132 Participants
n=172 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=83 Participants
|
1 Participants
n=89 Participants
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=83 Participants
|
5 Participants
n=89 Participants
|
8 Participants
n=172 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=83 Participants
|
89 Participants
n=89 Participants
|
172 Participants
n=172 Participants
|
|
Expanded Disability Status Scale (EDSS) score
|
2.00 units on a scale
n=83 Participants • Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
|
2.00 units on a scale
n=89 Participants • Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
|
2.00 units on a scale
n=172 Participants • Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
|
|
Multiple Sclerosis Functional Composite (MSFC) score
|
0.5 Z-score
STANDARD_DEVIATION 0.4 • n=83 Participants
|
0.6 Z-score
STANDARD_DEVIATION 0.5 • n=89 Participants
|
0.5 Z-score
STANDARD_DEVIATION 0.4 • n=172 Participants
|
|
Low-contrast acuity
|
36 letters
STANDARD_DEVIATION 10 • n=83 Participants
|
34 letters
STANDARD_DEVIATION 10 • n=89 Participants
|
35 letters
STANDARD_DEVIATION 10 • n=172 Participants
|
|
Health-related Quality of Life
|
126 units on a scale
STANDARD_DEVIATION 24 • n=83 Participants
|
126 units on a scale
STANDARD_DEVIATION 27 • n=89 Participants
|
126 units on a scale
STANDARD_DEVIATION 26 • n=172 Participants
|
|
Normalized Brain Parenchymal Volume
|
1,488,270 microliters
STANDARD_DEVIATION 107,046 • n=74 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
1,496,147 microliters
STANDARD_DEVIATION 88,025 • n=82 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
1,492,411 microliters
STANDARD_DEVIATION 97,270 • n=156 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
|
Normalized Gray Matter Volume
|
772,736 microliters
n=74 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
781,461 microliters
n=82 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
774,469 microliters
n=156 Participants • Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
|
PRIMARY outcome
Timeframe: 2 yearsConfirmed relapse defined as new or worsening symptoms referable to the central nervous system, lasting at least 24 hours, occurring at least 30 days since the prior attack, accompanied by worsening of the EDSS (\>= 0.5 points) or in the Functional Systems (FS) scales (2 points on at least one FS scale or 1 point on \>= two FS scales).
Outcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Proportion of Subjects That Experience a Relapse
|
0.32 proportion of participants
|
0.34 proportion of participants
|
SECONDARY outcome
Timeframe: 2 yearsAverage relapses per year
Outcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Annualized Relapse Rate
|
0.20 relapses per participant per year
Interval 0.11 to 0.35
|
0.34 relapses per participant per year
Interval 0.2 to 0.56
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Number of Relapses Requiring Treatment
|
0.15 relapses
Interval 0.08 to 0.3
|
0.28 relapses
Interval 0.15 to 0.51
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants analyzed had \> 1 MRI during the study (baseline and at least one follow-up MRI of sufficient quality).
Outcome measures
| Measure |
Low-dose Vitamin D3
n=65 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=74 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Number of New or Enlarging T2 Lesions
|
1.95 lesions
Interval 1.16 to 3.29
|
2.88 lesions
Interval 1.78 to 4.64
|
SECONDARY outcome
Timeframe: 2 yearsThe Expanded Disability Status Scale (EDSS) is an ordinal clinical rating scale based on a standard neurological examination and is used to measure global neurologic impairment in people with multiple sclerosis (MS). It ranges from a minimum of 0.0 (normal examination) to 10.0 (death due to MS) in half-point increments. A participant will be considered to have had sustained progression of disability if there is an increase in the EDSS score at month 12 by at least 1.0 point that is confirmed on the final examination one year later (month 24).
Outcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Proportion of Participants With Sustained Disability Progression
|
0.05 proportion of participants
|
0.08 proportion of participants
|
SECONDARY outcome
Timeframe: 2 yearsThe Multiple Sclerosis Functional Composite (MSFC) is a three-part measure of disability for people with multiple sclerosis, including measures of leg function/ambulation, arm/hand function and cognitive function. The three independent measures have different units. We take the reciprocal of the arm/hand function test, and then convert all measures to Z-scores. The average of the Z-scores from each measure yields the MSFC composite Z-score. A Z-score of 0 represents the population mean and positive scores indicate less disability. The MSFC was measured at baseline and up to 4 more times over 2 years.
Outcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Change in Multiple Sclerosis Functional Composite (MSFC) Score
|
0.051 Z-score
Interval 0.022 to 0.079
|
0.025 Z-score
Interval -0.003 to 0.053
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants analyzed did not have an MS relapse between screening and baseline visits and had at least one low-contrast acuity measure at a follow-up visit.
Low-contrast acuity was measured as binocular vision on a 2.5% Sloan chart at a distance of 2 meters. The chart is used to test the ability to discriminate gradually smaller gray letters with a 2.5% contrast level against a white background. The low-contrast acuity measure is scored as total letters read and ranges from 0 (no letters read) to 60 (all letters read). Low-contrast acuity was measured at baseline and up to 4 more times over 2 years and higher scores indicate better low-contrast acuity.
Outcome measures
| Measure |
Low-dose Vitamin D3
n=79 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=78 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Change in Low-contrast Acuity
|
0.82 letters
Interval -0.08 to 1.71
|
1.09 letters
Interval 0.2 to 1.99
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants analyzed completed a baseline FAMS questionnaire and at least 1 follow-up FAMS questionnaire.
The Functional Assessment of Multiple Sclerosis (FAMS) questionnaire is the quality of life (QOL) instrument used in this trial. It consists of 44 questions and the total score has a possible range of 0 to 176, with higher scores indicating better QOL. The FAMS questionnaire was obtained at baseline and up to 4 more times over 2 years.
Outcome measures
| Measure |
Low-dose Vitamin D3
n=79 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=78 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Change in Health-related Quality of Life
|
-0.78 score on a scale
Interval -2.38 to 0.82
|
-2.21 score on a scale
Interval -3.81 to -0.62
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants analyzed had \> 1 MRI during the study (baseline MRI and at least one follow-up MRI of sufficient quality).
Outcome measures
| Measure |
Low-dose Vitamin D3
n=65 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=74 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Change in Brain Parenchymal Volume
|
-0.29 microliters
Interval -0.78 to 0.2
|
-0.81 microliters
Interval -1.28 to -0.34
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants analyzed had \> 1 MRI during the study (baseline MRI and at least one follow-up MRI of sufficient quality).
Outcome measures
| Measure |
Low-dose Vitamin D3
n=65 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=74 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Change in Normalized Gray Matter Volume
|
-0.15 microliters
Interval -0.73 to 0.45
|
-0.87 microliters
Interval -1.43 to -0.31
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The quality of the clinical MRI scans acquired for this study prevented the analysis of cortical thickness.
Unable to analyze this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Development of Hypercalcemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Low-dose Vitamin D3
n=82 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 Participants
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Development of Nephrolithiasis
|
1 Participants
|
2 Participants
|
Adverse Events
Low-dose Vitamin D3
Serious events: 11 serious events
Other events: 66 other events
Deaths: 0 deaths
High-dose Vitamin D3
Serious events: 11 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose Vitamin D3
n=82 participants at risk
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 participants at risk
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/82 • Up to 2 years
|
0.00%
0/83 • Up to 2 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/82 • Number of events 1 • Up to 2 years
|
2.4%
2/83 • Number of events 2 • Up to 2 years
|
|
Pregnancy, puerperium and perinatal conditions
Unplanned pregnancy
|
6.1%
5/82 • Number of events 6 • Up to 2 years
|
3.6%
3/83 • Number of events 3 • Up to 2 years
|
|
Nervous system disorders
Unplanned hospitalization
|
1.2%
1/82 • Number of events 1 • Up to 2 years
|
3.6%
3/83 • Number of events 7 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Unplanned hospitalization
|
0.00%
0/82 • Up to 2 years
|
1.2%
1/83 • Number of events 5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Unplanned hospitalization
|
1.2%
1/82 • Number of events 1 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Unplanned hospitalization
|
1.2%
1/82 • Number of events 2 • Up to 2 years
|
0.00%
0/83 • Up to 2 years
|
|
Reproductive system and breast disorders
Unplanned hospitalization
|
0.00%
0/82 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Unplanned hospitalization
|
1.2%
1/82 • Number of events 1 • Up to 2 years
|
0.00%
0/83 • Up to 2 years
|
|
Eye disorders
Unplanned hospitalization
|
0.00%
0/82 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
|
Reproductive system and breast disorders
Planned hospitalization for elective procedure
|
1.2%
1/82 • Number of events 1 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Planned hospitalization for elective procedure
|
0.00%
0/82 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Planned hospitalization for elective procedure
|
0.00%
0/82 • Up to 2 years
|
1.2%
1/83 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Low-dose Vitamin D3
n=82 participants at risk
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
High-dose Vitamin D3
n=83 participants at risk
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
34.1%
28/82 • Number of events 44 • Up to 2 years
|
31.3%
26/83 • Number of events 40 • Up to 2 years
|
|
Nervous system disorders
Numbness or tingling
|
24.4%
20/82 • Number of events 22 • Up to 2 years
|
24.1%
20/83 • Number of events 21 • Up to 2 years
|
|
Nervous system disorders
Headache / worsened headache / migraine
|
15.9%
13/82 • Number of events 14 • Up to 2 years
|
21.7%
18/83 • Number of events 22 • Up to 2 years
|
|
Nervous system disorders
Fatigue / increased fatigue
|
17.1%
14/82 • Number of events 14 • Up to 2 years
|
13.3%
11/83 • Number of events 11 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain or swelling
|
8.5%
7/82 • Number of events 10 • Up to 2 years
|
13.3%
11/83 • Number of events 12 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
10/82 • Number of events 11 • Up to 2 years
|
8.4%
7/83 • Number of events 7 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
11.0%
9/82 • Number of events 12 • Up to 2 years
|
4.8%
4/83 • Number of events 5 • Up to 2 years
|
|
Psychiatric disorders
Depression / increased depression / severe depression
|
7.3%
6/82 • Number of events 6 • Up to 2 years
|
10.8%
9/83 • Number of events 10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
8.5%
7/82 • Number of events 7 • Up to 2 years
|
7.2%
6/83 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal pain / cramp / discomfort
|
9.8%
8/82 • Number of events 8 • Up to 2 years
|
4.8%
4/83 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
7.3%
6/82 • Number of events 7 • Up to 2 years
|
4.8%
4/83 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Limb pain
|
4.9%
4/82 • Number of events 6 • Up to 2 years
|
4.8%
4/83 • Number of events 4 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
5/82 • Number of events 5 • Up to 2 years
|
6.0%
5/83 • Number of events 5 • Up to 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
8.5%
7/82 • Number of events 7 • Up to 2 years
|
2.4%
2/83 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Urinary dysfunction
|
3.7%
3/82 • Number of events 3 • Up to 2 years
|
4.8%
4/83 • Number of events 6 • Up to 2 years
|
|
Ear and labyrinth disorders
Dizziness / increased dizziness
|
4.9%
4/82 • Number of events 4 • Up to 2 years
|
6.0%
5/83 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
Spasm / cramp (non-abdominal)
|
3.7%
3/82 • Number of events 3 • Up to 2 years
|
7.2%
6/83 • Number of events 6 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.1%
5/82 • Number of events 5 • Up to 2 years
|
4.8%
4/83 • Number of events 4 • Up to 2 years
|
|
Psychiatric disorders
Anxiety / worsening anxiety
|
3.7%
3/82 • Number of events 3 • Up to 2 years
|
6.0%
5/83 • Number of events 6 • Up to 2 years
|
|
Psychiatric disorders
Sleep disorder
|
6.1%
5/82 • Number of events 5 • Up to 2 years
|
13.3%
11/83 • Number of events 11 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat (+/- streptococcal infection)
|
4.9%
4/82 • Number of events 4 • Up to 2 years
|
2.4%
2/83 • Number of events 2 • Up to 2 years
|
Additional Information
Sandra D. Cassard, ScD
The Johns Hopkins University School of Medicine
Phone: 443-287-4353
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place