Trial Outcomes & Findings for GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases (NCT NCT01257802)
NCT ID: NCT01257802
Last Updated: 2017-06-27
Results Overview
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
Day 0 to 6-month post-intervention visit
Results posted on
2017-06-27
Participant Flow
2 of the 16 consented individuals were screen fails and therefore were not randomized.
Participant milestones
| Measure |
LUPRON
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
6 Month / 24 Week Visit
|
5
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
Baseline characteristics by cohort
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=8 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 years
n=5 Participants
|
28.25 years
n=7 Participants
|
27.93 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 6-month post-intervention visitPopulation: 8 subjects are listed in the breakdown of baseline characteristics. Samples were missing from one subject enrolled in the Placebo arm - therefore analysis throughout the majority of the reporting will include only 7 samples instead of 8 in the Placebo arm
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
Outcome measures
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=7 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
Baseline AMH (ng/ml)
|
2.07 ng/ml
Standard Deviation 1.92
|
3.87 ng/ml
Standard Deviation 4.00
|
|
Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit
6 month AMH (ng/ml)
|
0.72 ng/ml
Standard Deviation 1.07
|
0.24 ng/ml
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: 4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone
AMH level ≤1.0 predicts onset of menopause within 5 years in normal women
Outcome measures
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=7 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
Baseline AMH level >1 ng/ml
|
3 Participants
|
1 Participants
|
|
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
Baseline AMH level ≤1.0 ng/ml
|
3 Participants
|
6 Participants
|
|
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
6 Month AMH level ≤1.0 ng/ml
|
4 Participants
|
1 Participants
|
|
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
6 Month AMH level >1 ng/ml
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: 4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone
An AMH level of \>1 ng/ml and/or an antral follicle count of \>4 in either ovary is a strong predictor of residual ovarian function
Outcome measures
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=7 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.
Baseline AMH >1 ng/ml or AFC>4
|
4 Participants
|
6 Participants
|
|
Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.
6 Month AMH >1 ng/ml or AFC>4
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: 4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone
Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries
Outcome measures
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=7 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Mean Antral Follicle Count (AFC)
Baseline Mean antral follicle count (AFC)
|
10.3 # of ovarian follicles
Standard Deviation 9.29
|
14.4 # of ovarian follicles
Standard Deviation 12.4
|
|
Mean Antral Follicle Count (AFC)
6 Month Mean antral follicle count (AFC)
|
2.5 # of ovarian follicles
Standard Deviation 1.29
|
17.7 # of ovarian follicles
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: 4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone
Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients
Outcome measures
| Measure |
LUPRON
n=6 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=7 Participants
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Mean Ovarian Volume.
Baseline mean ovarian volume
|
9.59 cubic centimeters
Standard Deviation 2.69
|
7.68 cubic centimeters
Standard Deviation 3.50
|
|
Mean Ovarian Volume.
6 Month mean ovarian volume
|
4.26 cubic centimeters
Standard Deviation 1.93
|
6.97 cubic centimeters
Standard Deviation 5.54
|
Adverse Events
LUPRON
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LUPRON
n=6 participants at risk
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=8 participants at risk
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Infections and infestations
clostridium difficile infection
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 2 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for items listed below:
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for items listed below
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
Other adverse events
| Measure |
LUPRON
n=6 participants at risk
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
Placebo
n=8 participants at risk
depot leuprolide acetate 3.75 mg: Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
Placebo: Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
leg striae
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
hot flashes
|
33.3%
2/6 • Number of events 2 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
50.0%
4/8 • Number of events 4 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
hot and cold flashes
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Skin and subcutaneous tissue disorders
facial rash
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
increased sweating
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
2 menstruations in 28 day cycle
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Renal and urinary disorders
fluid retention
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Renal and urinary disorders
worsening hypertension
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Surgical and medical procedures
bleeding at catheter site
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
pain in right hip
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
pain in right forearm
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Gastrointestinal disorders
stool incontinence
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
menstrual spotting in between cycles
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Gastrointestinal disorders
abdominal pain
|
16.7%
1/6 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
0.00%
0/8 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
General disorders
Insomnia
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Reproductive system and breast disorders
night sweats
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Gastrointestinal disorders
bacterial overgrowth - GI related
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Musculoskeletal and connective tissue disorders
arthralgias
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Infections and infestations
viral upper respiratory infection
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Gastrointestinal disorders
nausea and vomiting
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Renal and urinary disorders
edema of left calf, foot, and hand
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
|
Blood and lymphatic system disorders
pancytopenia
|
0.00%
0/6 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
12.5%
1/8 • Number of events 1 • adverse events were collected from the time of randomization/baseline to the 6 month (24 week) follow up period The total interval of time for subjects in which AE's were collected spans approximately 6 months/24 weeks for each subject
|
Additional Information
W Joseph McCune MD Professor of Rheuntic Diseases University of Michigan
University of Michigan
Phone: 734 936 5560
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place