Trial Outcomes & Findings for Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia (NCT NCT00330382)
NCT ID: NCT00330382
Last Updated: 2014-12-19
Results Overview
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
325 participants
Primary outcome timeframe
6 months
Results posted on
2014-12-19
Participant Flow
A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.
Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.
Participant milestones
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
65
|
|
Overall Study
COMPLETED
|
43
|
48
|
|
Overall Study
NOT COMPLETED
|
24
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Baseline characteristics by cohort
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=67 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=65 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.25 years
STANDARD_DEVIATION 13.63 • n=93 Participants
|
60.64 years
STANDARD_DEVIATION 12.01 • n=4 Participants
|
59.42 years
STANDARD_DEVIATION 12.87 • n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=43 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=46 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Relative Percent Change in Total Lesion Area After 6 Months on Study
|
-20.6 percentage change
Standard Deviation 52.4
|
-17.1 percentage change
Standard Deviation 66.4
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease.
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=43 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=46 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants by Category of Clinical Response at 6 Months
Complete response (CR)
|
2 participants
|
2 participants
|
|
Number of Participants by Category of Clinical Response at 6 Months
Partial response (PR)
|
10 participants
|
12 participants
|
|
Number of Participants by Category of Clinical Response at 6 Months
Stable disease
|
27 participants
|
26 participants
|
|
Number of Participants by Category of Clinical Response at 6 Months
Disease progression
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baselie to 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period.
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=41 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=47 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen
|
1.2 score
Standard Deviation 23.7
|
3.6 score
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, "top photo shows a complete response relative to the bottom photo," through, "the same degree of disease is shown by top photo and bottom photo," to "bottom photo shows a complete response relative to the top photo." Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo.
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=45 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=46 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Clinical Impression From Photographs
|
4.0 score
Standard Deviation 1.0
|
3.6 score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=21 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=24 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)
|
-10.1 percentage change
Interval -52.3 to 24.6
|
-4.2 percentage change
Interval -33.6 to 36.7
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=19 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=22 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Relative Percent Change in Serum Neu Protein (ng/ml)
|
-3.9 percentage change
Interval -13.5 to 8.1
|
-8.1 percentage change
Interval -15.3 to 6.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The participants who have complete data are analyzed in this outcome measure.
100% x (Posttreatment value - pretreatment value)/(pretreatment value)
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=21 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=24 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Relative Percent Change in Protease Activity (Delta RFU/Min/µg)
|
15.7 percentage change
Interval -23.8 to 74.9
|
17.2 percentage change
Interval -10.3 to 30.9
|
SECONDARY outcome
Timeframe: Randomized date to Off-study date, up to 21 monthsThe onset of adverse event is between the randomizaiton date and off-study date
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=67 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=65 Participants
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Participants Report at Least 1 Adverse Event During the Study
Yes: report at least 1 AE
|
33 participants
|
25 participants
|
|
Number of Participants Report at Least 1 Adverse Event During the Study
No: no AE reported
|
34 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: The participants whose data are available and complete are included in the analysis.
Outcome measures
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=45 Participants
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months
Buccal-Cell New
|
-8.9 percentage change
Interval -24.5 to 18.5
|
—
|
|
Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months
Protease Activity
|
16.2 percentage change
Interval -10.0 to 27.0
|
—
|
|
Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months
Serum Neu (n=41)
|
-4.1 percentage change
Interval -11.3 to 0.7
|
—
|
Adverse Events
Arm I (Bowman-Birk Inhibitor Concentrate)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=67 participants at risk
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=65 participants at risk
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Surgical and medical procedures
ADMISSION FOR ORAL SURGERY ON FLOOR MOUTH
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
C/O "LUMP" TO RT. LOWER GUM
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
COLD
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
EPIGASTRIC PAIN
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Infections and infestations
FINGER INFECTION - LEFT RING
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Cardiac disorders
HEART PROBLEMS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
Other adverse events
| Measure |
Arm I (Bowman-Birk Inhibitor Concentrate)
n=67 participants at risk
Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months
Bowman-Birk inhibitor concentrate: Given orally
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=65 participants at risk
Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Surgical and medical procedures
6 CROWNS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
ABD PN AND BLOATING
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
BAD BREATH
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
BAD CANKER LOWER LIP
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
BAD COLD
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
BLEEDING HEMORRHOIDS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
BLOATED
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS/FLU
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Cardiac disorders
CAD
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
CANKER SORES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Cardiac disorders
CARDIAC STENT
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Cardiac disorders
CARDIOVASCULAR OTHER - GENERAL
|
1.5%
1/67 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Cardiac disorders
CHEST PAIN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
3.1%
2/65 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
CHIP FX ON RIGHT BIG TOE
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
COLD
|
4.5%
3/67 • Number of events 3 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Infections and infestations
COLD SORES
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
COMPLAINED OF TASTE
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Injury, poisoning and procedural complications
CUT HAND WHILE PLAYING SOCCER AND NEEDED STITCHES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Psychiatric disorders
DECREASED SEXUAL APPETITE
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
DENTAL IMPLANTS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
DIARRHEA
|
4.5%
3/67 • Number of events 4 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
DIDN'T LIKE TASTE AFTER RUN IN AND THEN RANDOMIZED, STATED THAT HE "DIDN'T FEEL IT WAS WORKING".
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
DRY LIPS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
DRY MOUTH
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Ear and labyrinth disorders
EAR INFECTION/IRREGULAR BUMP
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
EPIGASTRIC PAIN
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
EPIGASTRIC PAIN AND NAUSEA
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Injury, poisoning and procedural complications
FALL, COMPRESSION OF T11-L1 VERTEBRAL BODY
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
FISSURE FX
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
FLU X 1
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
FLU X 2
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
FLU X 6 D
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
FLU/COLD
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Surgical and medical procedures
FNA AND BIOPSY OF MASS INTRAMUSCULAR LIPOMA
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
GAS-BUT THIS HAS DISAPPEARED AFTER BEING ON POWDER FOR ONE WEEK.
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
GUM BLEEDING
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
GUM EROSION (SONIC TOOTHBRUSH)
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
GUMS FEEL SORE/TENDER
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
HANDS NUMB
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
HEAD COLD
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
HEADACHE
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
HEADACHES
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
HIVES
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Surgical and medical procedures
HOSPITALIZAED RIGHT KNEE REPLACEMENT
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
INCREASED HAIR LOSS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
INCREASED SENSITIVITY WITH SPICY FOOD, IE FROM MED TO MILD SALSA
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
INCREASED TONGUE PAIN
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
ITCHY FOREARM, POSSIBLE BUG BITE REACTION
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Renal and urinary disorders
KIDNEY STONES
|
1.5%
1/67 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
LOOSE STOOLS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Psychiatric disorders
LOWER LEFT JAW LESION FEELS ODD/STRETCHY
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
LT. FOOT RUPTURED TENDON
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
LT. FOOT THROMBUS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
LT. FOOT THROMBUS CONTINUES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 3 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MASS 2-3 CM ON CT OF ABDOMEN
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
MOUTH SORES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
NAUSEA
|
3.0%
2/67 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
NAUSEA/ABD CRAMPING
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEW SPOTS IN THROAT
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
ORAL SORENESS
|
3.0%
2/67 • Number of events 3 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
POISON OAK
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Injury, poisoning and procedural complications
PT FELL. LEFT EYEBROW AREA BRUISED
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.0%
2/67 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
REDNESS OUTER ASPECT LIPS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
ROOF OF MOUTH MORE SENSITIVE
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
RT HAND LITTLE FINGER BROKEN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
SCIATIC LEG PAIN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
SCIATICA
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
SHINGLES
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS INFECTION, TOOK ZITHROMAX
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
SOFT STOOL
|
3.0%
2/67 • Number of events 2 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
SORE - TONGUE
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
SORE MOUTH
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
SORE MOUTH - CORNERS AND GUMS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
SORE TONGUE BOTH SIDES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
STOMACH ACHE
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
STOMACH DISTRESS WITH SPICY FOODS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
STOMACH FLU
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Surgical and medical procedures
SURGERY ON FINGER
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
TASTED LIKE YEAST
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
TASTES BAD
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
THINNING HAIR
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT DRY AND CHAULKY
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Psychiatric disorders
TIRED AND DIDN'T FEEL LIKE TAKING
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
General disorders
TIRED. IN RETROSPECT FELT TIRED DUE TO WORK.
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
TONGUE NUMBNESS COMES AND GOES
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Nervous system disorders
TONGUE NUMBNESS, TINGLING AND DRY MOUTH
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
TOOTH EXTRACTION
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
TOOTH INFECTION
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
TOOTH PULLED/EAR PAIN/ TOOTH DECAY
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
TOUNGE PAIN CONTINUES
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Musculoskeletal and connective tissue disorders
TOUNGE SORENESS
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
ULCERATION (SMALL)
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Skin and subcutaneous tissue disorders
ULCERATION X3
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Surgical and medical procedures
UNDERGOING ROOT CANAL
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION AND SORE THROAT
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
UPSET STOMACH
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
UPSET STOMACH AND GAS
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Gastrointestinal disorders
VOMITING - 2X THEN STOPPED
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Metabolism and nutrition disorders
WEIGHT LOSS 10LB DUE TO PAIN
|
0.00%
0/67 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
1.5%
1/65 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
|
Infections and infestations
YEAST INFECTION
|
1.5%
1/67 • Number of events 1 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
0.00%
0/65 • The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
|
Additional Information
Dr. Frank Meyskens, Jr.
University of California, Irvine
Phone: 714-456-6310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60