Trial Outcomes & Findings for Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E (NCT NCT01792115)
NCT ID: NCT01792115
Last Updated: 2020-11-04
Results Overview
Biochemical response defined as number of patients with normal transaminases AST \<=32 or ALT \<=35 U/L at end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Vit E 200 IU/d
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Vit E 200 IU/d
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Baseline characteristics by cohort
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=7 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Diabetes
Has Diabetes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Diabetes
No Diabetes
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksBiochemical response defined as number of patients with normal transaminases AST \<=32 or ALT \<=35 U/L at end of treatment.
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Biochemical: Number of Patients With Normal Transaminases at End of Treatment.
|
6 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPhysiological response defined as absolute change in liver fat measured by 1H-MRS
Outcome measures
| Measure |
Vit E 200 IU/d
n=6 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Physiological: Absolute Change in Liver Fat
|
-1.9 percent liver fat
Standard Deviation 9.6
|
-7.6 percent liver fat
Standard Deviation 3.3
|
-0.6 percent liver fat
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksAbsolute Change in AST \[u/l\] by week 24
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Absolute Change in AST
|
-5.6 u/l
Standard Deviation 11.1
|
-1.8 u/l
Standard Deviation 4.5
|
-10.6 u/l
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPercent change in AST by week 24
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Percent Change in AST
|
-0.15 percent
Standard Deviation 0.29
|
-0.07 percent
Standard Deviation 0.21
|
-0.24 percent
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksAbsolute Change in ALT \[u/l\] by week 24
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Absolute Change in ALT
|
-8 u/l
Standard Deviation 16.7
|
-8.3 u/l
Standard Deviation 10.7
|
-22 u/l
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPercent change in ALT by week 24
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Percent Change in ALT
|
-0.17 percent
Standard Deviation 0.44
|
-0.19 percent
Standard Deviation 0.23
|
-0.35 percent
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksChange in GGT by week 24 (U/L)
Outcome measures
| Measure |
Vit E 200 IU/d
n=7 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=5 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Absolute Change in GGT
|
-6.1 u/l
Standard Deviation 24.5
|
-22.8 u/l
Standard Deviation 50
|
-11 u/l
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPercent change in liver fat by week 24
Outcome measures
| Measure |
Vit E 200 IU/d
n=6 Participants
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=6 Participants
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 Participants
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Percent Change in Liver Fat
|
0.33 percent of percent liver fat
Standard Deviation 0.93
|
-0.42 percent of percent liver fat
Standard Deviation 0.18
|
-0.10 percent of percent liver fat
Standard Deviation 0.48
|
Adverse Events
Vit E 200 IU/d
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Vitamin E 400
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vitamin E 800
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vit E 200 IU/d
n=7 participants at risk
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=7 participants at risk
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 participants at risk
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Renal and urinary disorders
Diuretic-induced hypokalemia
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Gastrointestinal disorders
Diverticulitis with recto-vaginal fistula
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Cardiac disorders
Hypertensive crisis (medication non-compliance)
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
Other adverse events
| Measure |
Vit E 200 IU/d
n=7 participants at risk
Subjects randomized to vitamin E 200 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 200 IU/d: Supplement-low dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 400
n=7 participants at risk
Subjects randomized to vitamin E 400 IU/day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU/day for up to 120 weeks following the initial 24 week period.
Vitamin E 400 IU/d: Supplement-intermediate dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
Vitamin E 800
n=8 participants at risk
Subjects randomized to vitamin E 800 IU /day for 24 weeks; invited to optional extension of open- label vitamin E 800 IU /day for up to 120 weeks following the initial 24 week period.
Vitamin E 800 IU/d: Supplement High Dose
Diet and Exercise: Diet and Exercise for all Arms of the study at baseline
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
25.0%
2/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Nervous system disorders
Headache/Migraine
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Infections and infestations
Viral gastroenteritis
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Reproductive system and breast disorders
Galactorrhea
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Reproductive system and breast disorders
Breast cancer
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Cardiac disorders
Hypertensive crisis
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle tear
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Infections and infestations
Herpes Keratitis
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Cardiac disorders
Vasovagal
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
14.3%
1/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
25.0%
2/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Vascular disorders
Epistaxis
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
25.0%
2/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis (post-anesthesia)
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Vascular disorders
Hypertriglyceridemia exacerbation
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Musculoskeletal and connective tissue disorders
Jaw swelling
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
12.5%
1/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency or anemia
|
42.9%
3/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
57.1%
4/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
50.0%
4/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
|
Gastrointestinal disorders
Overt gastrointestinal bleeding
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
0.00%
0/7 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
25.0%
2/8 • AE data were collected over 144 weeks, from starting treatment to completion of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place