Trial Outcomes & Findings for Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection (NCT NCT00513461)
NCT ID: NCT00513461
Last Updated: 2018-08-10
Results Overview
Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Baseline to week 24
Results posted on
2018-08-10
Participant Flow
Participant milestones
| Measure |
Arm I (SAMe)
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
Baseline characteristics by cohort
| Measure |
Arm I (SAMe)
n=57 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=53 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
57.88 years
STANDARD_DEVIATION 5.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data anlysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Measured using an Food and Drug Administration (FDA)-approved assay. Mean change over time for the SAMe and placebo groups will be estimated. Differences in the change over time between the treated and control groups will be tested using a two-group repeated measures analysis of variance model.
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=40 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in Serum AFP Levels
|
-1.928 ng/mL
Standard Deviation 20.304
|
5.855 ng/mL
Standard Deviation 29.207
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
To determine whether treatment with SAMe for 24 weeks reduces serum levels of des-gamma carboxyprothrombin (DCP) in patients with advanced liver disease due to chronic hepatitis C (hepatocellular carcinoma tumor markers).
Outcome measures
| Measure |
Arm I (SAMe)
n=27 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=26 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Treatment-related Changes in Serum DCP for Hepatocellular Carcinoma
|
0.259 ng/mL
Standard Deviation 0.976
|
0.647 ng/mL
Standard Deviation 1.491
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
AFP-L3 assay will be performed by Wako Laboratories using their LiBASys platform.
Outcome measures
| Measure |
Arm I (SAMe)
n=27 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=26 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Treatment-related Changes in Serum AFP-L3 (Expressed as the Percentage of Total AFTP) for Hepatocellular Carcinoma
|
0.144 percentage of AFP-L3/AFP
Standard Deviation 1.146
|
0.335 percentage of AFP-L3/AFP
Standard Deviation 3.486
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Change in SAMe levels
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
SAMe
|
414.242 nmol/L
Standard Deviation 744.373
|
-9.085 nmol/L
Standard Deviation 54.621
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
S-adenosylhomocysteine (SAH)
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - S-adenosylhomocysteine (SAH)
|
16.326 nmol/L
Standard Deviation 28.212
|
-3.456 nmol/L
Standard Deviation 13.104
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Methionine will be measured using HPLC with fluorescence detection.
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - Methionine
|
0.421 µmol/L
Standard Deviation 18.794
|
-2.894 µmol/L
Standard Deviation 23.669
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Total homocysteine (tHcy)
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - Total Homocysteine (tHcy)
|
0.266 µmol/L
Standard Deviation 2.394
|
-0.677 µmol/L
Standard Deviation 2.478
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Plasma GSH will be measured using HPLC with fluorescence detection.
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - Plasma GSH
|
0.455 µmol/L
Standard Deviation 1.425
|
0.285 µmol/L
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
malondialdehyde
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - Malondialdehyde (MDA)
|
-0.007 µmol/L
Standard Deviation 0.848
|
-0.002 µmol/L
Standard Deviation 1.162
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Serum marker of oxidative stress. One mechanism by which SAMe is hypothesized to be beneficial is by reducing oxidative stress.
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=41 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in SAMe Metabolites - 4-hydroxynonenal (4-HNE)
|
-0.185 µg/mL
Standard Deviation 0.716
|
-0.032 µg/mL
Standard Deviation 0.448
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
AST measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.
Outcome measures
| Measure |
Arm I (SAMe)
n=44 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=43 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in Markers of Liver Disease - AST
|
-0.755 IU/L
Standard Deviation 37.531
|
1.723 IU/L
Standard Deviation 40.709
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
ALT measurements will be performed in a College of American Pathologists (CAP)-certified lab using FDA-approved assays.
Outcome measures
| Measure |
Arm I (SAMe)
n=44 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=43 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Change in Markers of Liver Disease - ALT
|
-9.548 IU/L
Standard Deviation 34.786
|
0.019 IU/L
Standard Deviation 41.165
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Change in HCV RNA levels. Serum level of HVC RNA was measured using COBAS TaqMan HCV test (Roche Molecular Systems).
Outcome measures
| Measure |
Arm I (SAMe)
n=36 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=35 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
HCV RNA
|
-259327.69 IU/mL
Standard Deviation 3084015.42
|
-19968.89 IU/mL
Standard Deviation 2425010.48
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Physical Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change in QOL = (Week 24 score - Baseline score).
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=43 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Changes in Quality of Life - Physical Score
|
-0.4 units on a scale
Standard Deviation 11.73
|
0.03 units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: All subjects who completed the week 24 visit as planned were included in the data analysis. The number of subjects in each analysis differed slightly because the number of subjects with data at both time points (i.e., week 0 and week 24) varied depending on the outcome measured.
Change from Baseline to Week 24 in Quality of life as as assessed with Short Form (SF)-36 Mental Component Scores. Measured quality of life using the SF-36, a widely used and general questionnaire of quality of life. Possible scores range from 0 and 100. High scores reflect good QOL and low scores reflect bad QOL. Change = (Week 24 score - Baseline score).
Outcome measures
| Measure |
Arm I (SAMe)
n=43 Participants
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=43 Participants
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Changes in Quality of Life - Mental Score
|
0.83 scores on a scale
Standard Deviation 15.06
|
-2.83 scores on a scale
Standard Deviation 11.76
|
Adverse Events
Arm I (SAMe)
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (SAMe)
n=57 participants at risk
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=53 participants at risk
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Infections and infestations
ABDOMINAL CELLULITIS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Vascular disorders
ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEG
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Hepatobiliary disorders
HEPATOCELLULAR CARCINOMA
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
LEFT THIGH ABSCESS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Cardiac disorders
NON-ST ELEVATION MIOCARDIAL INFARCTION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
PNEUMONIA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
SMALL BOWEL INFLAMATION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Hepatobiliary disorders
SPLENOMEGALY SECONDARY TO PORTAL HYPERTENSION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
Other adverse events
| Measure |
Arm I (SAMe)
n=57 participants at risk
Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
Arm II (Placebo)
n=53 participants at risk
Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
immunoenzyme technique: Correlative studies
high performance liquid chromatography: Correlative studies
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
PAIN IN KNEE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN LEFT SIDE OF CHEST
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN ON ANKLE JOINTS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN ON HIP
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN ON KNEE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
PINCHED NERVE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
QUEASINESS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH ON BOTH ARMS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH ON EXTREMETIES
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT INFECTION
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
SINUSITIS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN RASH
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
SPRAINED ANKLE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
STIFF NECK
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL CRAMPS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Immune system disorders
ALLERGIC RHINITIS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
ANAL IRRITATION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
ANXIETY
|
5.3%
3/57 • Number of events 3 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS PAIN, KNEES
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS PAIN, LOWER BACK
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
ASCITES
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
BAD GAS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
BLACK OUT
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BLEEDING ESPHAGEAL VARICES
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BLOOD IN STOOLS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Eye disorders
BLURRED VISION
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Endocrine disorders
BORDERLINE DIABETES
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Reproductive system and breast disorders
BREAST TENDERNESS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
BROKEN TOOTH-UNCOMPLICATED
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
BRUISING R LEG
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
CHEST CONGESTION
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
General disorders
CHILLS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
CHRONIC ASCITES
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Ear and labyrinth disorders
CLICKING SOUND IN THE HEAD
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
General disorders
COLD
|
7.0%
4/57 • Number of events 5 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
General disorders
COMMON COLD
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
CONSTIPATION
|
21.1%
12/57 • Number of events 17 • Through study completion, an average of 30 weeks.
|
9.4%
5/53 • Number of events 6 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
3/57 • Number of events 3 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
CYST ON PATELLA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
DARK COLORED URINE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
DECREASED INSOMNIA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DENTAL IMPLANT SURGERY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
DEPRESSION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Endocrine disorders
DIABETES MELLITUS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DIARRHEA
|
35.1%
20/57 • Number of events 31 • Through study completion, an average of 30 weeks.
|
24.5%
13/53 • Number of events 17 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DIARRHEA 4-6 STOOLS/DAY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DIFFUSE ABDOMINAL PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
DISLOCATION OF LEFT SHOULDER
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
DIZZINESS
|
8.8%
5/57 • Number of events 6 • Through study completion, an average of 30 weeks.
|
7.5%
4/53 • Number of events 6 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DRY MOUTH
|
17.5%
10/57 • Number of events 10 • Through study completion, an average of 30 weeks.
|
22.6%
12/53 • Number of events 13 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
DRYNESS OF MOUTH
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Ear and labyrinth disorders
EARS RINGING
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
ELEVATED AFP
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Investigations
ELEVATED CREATININE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Investigations
ELEVATED INR
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
EXTRA GAS FLATULENCE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Eye disorders
EYES HURT
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Immune system disorders
FACIAL SWELLING OF ALLERGIC ORIGIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
FALL, HIP AND BACK PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
General disorders
FATIGUE
|
26.3%
15/57 • Number of events 19 • Through study completion, an average of 30 weeks.
|
17.0%
9/53 • Number of events 11 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
FEET AND LEGS CRAMPS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
General disorders
FEVER
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
FLATULENCE
|
33.3%
19/57 • Number of events 22 • Through study completion, an average of 30 weeks.
|
41.5%
22/53 • Number of events 25 • Through study completion, an average of 30 weeks.
|
|
General disorders
FLU
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
General disorders
FLU-LIKE SYMPTOMS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
7.5%
4/53 • Number of events 4 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
FOOD POISONING
|
3.5%
2/57 • Number of events 2 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
FORGETFULNESS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE 5TH R METACARPAL
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
GAS-FLATULENCE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
GI CONSTIPATION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
GUM BLEEDING
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
HAPPIER
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
HEADACHE
|
22.8%
13/57 • Number of events 16 • Through study completion, an average of 30 weeks.
|
20.8%
11/53 • Number of events 13 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
HEADACHE-SINUS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
HEARTBURN
|
12.3%
7/57 • Number of events 9 • Through study completion, an average of 30 weeks.
|
7.5%
4/53 • Number of events 4 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Endocrine disorders
HOT FLUSHES
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Metabolism and nutrition disorders
HUNGRIER
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
HYPERSOMNIA
|
3.5%
2/57 • Number of events 2 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INCREASE IN FLATULENCE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INCREASE NUMBER OF STOOLS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
INCREASE PEE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INCREASED DIARRHEA
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INCREASED FLATULENCE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INCREASED STOMACH PAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
INCREASED SWEATING
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
INCREASED URINATION
|
21.1%
12/57 • Number of events 13 • Through study completion, an average of 30 weeks.
|
17.0%
9/53 • Number of events 10 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
INFECTED SEBACEOUS CYST R. AXILA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
INSOMNIA
|
15.8%
9/57 • Number of events 11 • Through study completion, an average of 30 weeks.
|
15.1%
8/53 • Number of events 9 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
INTERMITTENT HEADACHE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
INTESTINAL FLU
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
INVOLUNTARY MOVEMENT
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
ITCHINESS ALL OVER THE BODY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
ITCHING
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
JOINT PAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
KNEE PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LEFT LEG VASCULAR CLAUDICATION
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LEFT SIDE PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LEG CRAMPS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LOWER BACK PAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LOWER BACK SURGERY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LOWER BACKACHE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
LOWER EXTREMITY EDEMA
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
MACULOPAPULAR RASH ON TORSO
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MANIA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 5 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
MEMORY LOSS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
MILD RASH
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION
|
3.5%
2/57 • Number of events 7 • Through study completion, an average of 30 weeks.
|
3.8%
2/53 • Number of events 2 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION DEPRESSION
|
1.8%
1/57 • Number of events 2 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION-ANXIETY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION-HAPPY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
MOOD ALTERATION:ANXIETY
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMPS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMPS OF BOTH LEGS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE MOVEMENT
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN (NECK)
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
NAUSEA
|
31.6%
18/57 • Number of events 20 • Through study completion, an average of 30 weeks.
|
13.2%
7/53 • Number of events 8 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
NOSE BLEEDING
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
OLECRANON BURSITIS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN BOTH HANDS AND FEET
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
STIFFNESS OF JOINTS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
STOMACH ACHE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
STOMACH CRAMPS
|
1.8%
1/57 • Number of events 3 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
STOMACH FLU
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
36.8%
21/57 • Number of events 28 • Through study completion, an average of 30 weeks.
|
17.0%
9/53 • Number of events 10 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
8.8%
5/57 • Number of events 5 • Through study completion, an average of 30 weeks.
|
11.3%
6/53 • Number of events 9 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
SWEATING "NIGHT"
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Blood and lymphatic system disorders
SWELLING OF ANKLES
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Nervous system disorders
TICS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
General disorders
TIREDNESS FATIGUE
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
TOOTH EXTRACTION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Skin and subcutaneous tissue disorders
ULCERATION OF THE LIP
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
UPSET STOMACH
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Renal and urinary disorders
URINE ODOR
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Reproductive system and breast disorders
VAGINAL IRRITATION
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
VAGINAL YEAST INFECTION
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Infections and infestations
VIRAL INFECTION INCLUDING COUGHING
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Investigations
VITAMIN D DEFICIENCY
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
VIVID DREAMS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
8.8%
5/57 • Number of events 6 • Through study completion, an average of 30 weeks.
|
7.5%
4/53 • Number of events 4 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
WEAKNESS
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Investigations
WEIGHT GAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Psychiatric disorders
WORSENING OF ANXIETY
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Musculoskeletal and connective tissue disorders
WORSENING OF BACK PAIN
|
1.8%
1/57 • Number of events 1 • Through study completion, an average of 30 weeks.
|
0.00%
0/53 • Through study completion, an average of 30 weeks.
|
|
Endocrine disorders
WORSENING OF BASELINE DIABETES MELLITUS
|
0.00%
0/57 • Through study completion, an average of 30 weeks.
|
1.9%
1/53 • Number of events 1 • Through study completion, an average of 30 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60