Trial Outcomes & Findings for Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia (NCT NCT01165307)
NCT ID: NCT01165307
Last Updated: 2017-01-20
Results Overview
The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.
COMPLETED
PHASE4
77 participants
Measured at 12 months following initial treatment
2017-01-20
Participant Flow
Subjects were recruited at Mayo Clinic in Rochester, Minnesota from September 2009 to February 2013.
77 subjects were initially consented, but 10 subjects were not randomized because 4 declined participation after consent, 4 reported spontaneous improvement during initial evaluation, 1 had an abnormal Pap smear indicating treatment, and 1 had a polypoid mass on hysteroscopy.
Participant milestones
| Measure |
Medical Therapy
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
19
|
31
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
Reasons for withdrawal
| Measure |
Medical Therapy
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Subject not available for contact
|
1
|
0
|
Baseline Characteristics
Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia
Baseline characteristics by cohort
| Measure |
Medical Therapy
n=33 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=34 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
42.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
|
15 units on a scale
Interval 0.0 to 131.0
|
0 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
SF-12 Physical Scale
|
54.2 units on a scale
Standard Deviation 5.9
|
54.5 units on a scale
Standard Deviation 4.2
|
|
Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
SF-12 Mental Scale
|
49.8 units on a scale
Standard Deviation 10.0
|
53.8 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )
|
100 units on a scale
Interval 87.2 to 100.0
|
100 units on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Hemoglobin at 12 Months
|
13.2 g/dL
Interval 12.5 to 13.8
|
13.4 g/dL
Interval 12.7 to 13.9
|
SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Change in Hemoglobin
|
0.0 g/dL
Interval -0.6 to 0.7
|
0.5 g/dL
Interval 0.0 to 2.2
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Ferritin at 12 Months
|
25.0 ug/L
Interval 17.0 to 33.0
|
26.5 ug/L
Interval 15.0 to 39.0
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Change in Ferritin From Baseline
|
4.0 ug/L
Interval -1.0 to 16.0
|
10.0 ug/L
Interval 4.0 to 22.0
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Direct Medical Costs
Primarily hospital billed services
|
1300 dollars
Standard Deviation 1170
|
3494 dollars
Standard Deviation 4006
|
|
Direct Medical Costs
Primarily physician billed services
|
1601 dollars
Standard Deviation 1576
|
1837 dollars
Standard Deviation 1602
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Indirect Medical Costs
Indirect costs C
|
968 dollars
Standard Deviation 1534
|
138 dollars
Standard Deviation 421
|
|
Indirect Medical Costs
Indirect costs A
|
741 dollars
Standard Deviation 1174
|
124 dollars
Standard Deviation 403
|
|
Indirect Medical Costs
Indirect costs B
|
264 dollars
Standard Deviation 467
|
27 dollars
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea "normal pattern" (none of the above patterns).
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Bleeding Pattern at 12 Months
Amenorrhea
|
5 participants
|
16 participants
|
|
Bleeding Pattern at 12 Months
Irregular/Infrequent bleeding
|
4 participants
|
6 participants
|
|
Bleeding Pattern at 12 Months
Eumenorrhea
|
8 participants
|
9 participants
|
|
Bleeding Pattern at 12 Months
Prolonged bleeding
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)
|
0.4 mm
Interval 0.0 to 3.0
|
0.0 mm
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Measured at 12 months following initial treatmentPopulation: Only subjects who completed the 12 month visit were included in the analysis.
Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.
Outcome measures
| Measure |
Medical Therapy
n=19 Participants
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=31 Participants
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
Subject Satisfaction at 12 Months
Totally satisfied
|
12 participants
|
30 participants
|
|
Subject Satisfaction at 12 Months
Generally satisfied
|
4 participants
|
1 participants
|
|
Subject Satisfaction at 12 Months
Acceptable improvement
|
2 participants
|
0 participants
|
|
Subject Satisfaction at 12 Months
Unacceptable
|
1 participants
|
0 participants
|
Adverse Events
Medical Therapy
Radiofrequency Endometrial Ablation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medical Therapy
n=33 participants at risk
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
|
Radiofrequency Endometrial Ablation
n=34 participants at risk
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
|
|---|---|---|
|
General disorders
Mild headache
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
General disorders
Moderate headache
|
12.1%
4/33 • Number of events 4
|
0.00%
0/34
|
|
Gastrointestinal disorders
Gastrointestinal adverse events
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
|
Psychiatric disorders
Depression
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
Extremity edema
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
General disorders
Weight gain
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Cardiac disorders
Increased blood pressure
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place