Trial Outcomes & Findings for Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis (NCT NCT00323960)
NCT ID: NCT00323960
Last Updated: 2023-03-28
Results Overview
The PRINTO Juvenile Dermatomyositis (JDM) core set variables are: 1. muscle strength by the mean of the Childhood Myositis Assessment Scale (CMAS); 2. physician's global assessment of disease activity on a 10 cm Visual Analogue Scale (VAS); 3. global disease activity assessment by the mean of the Disease Activity Index (DAS); 4. parent's/patient's global assessment of overall well-being on a 10 cm VAS; 5. functional ability assessment by the mean of the Childhood Health Assessment Questionnaire (CHAQ) 6. health-related quality of life assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
139 participants
Primary outcome timeframe
6 months
Results posted on
2023-03-28
Participant Flow
Participant milestones
| Measure |
Methylprednisolone Pulse+Prednisone
Group 1 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent
|
Methylprednisolone Pulse+Prednisone+Cyclosporine A
Group 2 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent plus cyclosporine A
|
Methylprednisolone Pulses+Prednisone+Methotrexate
Group 3 received 3 pulses of methylprednisolone and has been randomized to prednisone or equivalent plus methotrexate
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
46
|
|
Overall Study
COMPLETED
|
47
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis
Baseline characteristics by cohort
| Measure |
MPDN+PDN
n=47 Participants
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
MPDN+PDN+CSA
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
MPDN+PDN+MTX
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
47 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
139 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
7.2 years
n=99 Participants
|
8.9 years
n=107 Participants
|
7.1 years
n=206 Participants
|
7.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=99 Participants
|
13 participants
n=107 Participants
|
10 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
Region of Enrollment
Algeria
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Argentina
|
11 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
3 participants
n=206 Participants
|
13 participants
n=7 Participants
|
|
Region of Enrollment
Colombia
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
France
|
3 participants
n=99 Participants
|
10 participants
n=107 Participants
|
11 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Latvia
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Norway
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Serbia
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Slovakia
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Slovenia
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
Venezuela
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
disease duration
|
2.6 months
n=99 Participants
|
2.7 months
n=107 Participants
|
2.8 months
n=206 Participants
|
2.8 months
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Comparison between group 2 (PDN+CSA) and 3 (PDN+MTX) combined versus group 1 (PDN)
The PRINTO Juvenile Dermatomyositis (JDM) core set variables are: 1. muscle strength by the mean of the Childhood Myositis Assessment Scale (CMAS); 2. physician's global assessment of disease activity on a 10 cm Visual Analogue Scale (VAS); 3. global disease activity assessment by the mean of the Disease Activity Index (DAS); 4. parent's/patient's global assessment of overall well-being on a 10 cm VAS; 5. functional ability assessment by the mean of the Childhood Health Assessment Questionnaire (CHAQ) 6. health-related quality of life assessment.
Outcome measures
| Measure |
Group 1 (MPDN+PDN)
n=47 Participants
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
Group 2 (MPDN+PDN+CSA)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
Group 3 (MPDN+PDN+MTX)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by > 30%.
|
24 Participants
|
32 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 60 monthsClinical remission is defined as the status of inactive disease for at least 6 continuous months defined as normal muscle strength (CMAS equal to 52) and physician global assessment of disease activity equal to 0.
Outcome measures
| Measure |
Group 1 (MPDN+PDN)
n=47 Participants
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
Group 2 (MPDN+PDN+CSA)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
Group 3 (MPDN+PDN+MTX)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Time to Clinical Remission
|
5.99 events per 1000 persons-time
Interval 3.0 to 11.98
|
4.95 events per 1000 persons-time
Interval 2.36 to 10.38
|
13.39 events per 1000 persons-time
Interval 8.07 to 22.21
|
SECONDARY outcome
Timeframe: 60 monthsTime to major therapeutic changes is defined as the addition of CSA or MTX or any other disease-modifying antirheumatic drug (DMARS) in any of the 3 groups or discontinuation of assigned therapy for any reason including adverse events. Retention on treatment was used as main measure of effectiveness.
Outcome measures
| Measure |
Group 1 (MPDN+PDN)
n=47 Participants
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
Group 2 (MPDN+PDN+CSA)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
Group 3 (MPDN+PDN+MTX)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Time to Major Therapeutic Changes
|
30.52 events per 1000 persons-time
Interval 21.34 to 43.65
|
17.52 events per 1000 persons-time
Interval 11.31 to 27.16
|
13.92 events per 1000 persons-time
Interval 8.65 to 22.39
|
SECONDARY outcome
Timeframe: 60 monthsPrednisone or equivalent glucocorticoid discontinuation is defined as the complete discontinuation of glucocorticoids
Outcome measures
| Measure |
Group 1 (MPDN+PDN)
n=47 Participants
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
Group 2 (MPDN+PDN+CSA)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
Group 3 (MPDN+PDN+MTX)
n=46 Participants
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Time to Prednisone, or Equivalent, Discontinuation
|
15.91 events per 1000 persons-time
Interval 10.15 to 24.94
|
27.82 events per 1000 persons-time
Interval 19.56 to 39.55
|
24.42 events per 1000 persons-time
Interval 16.5 to 36.14
|
Adverse Events
MPDN+PDN
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
MPDN+PDN+CSA
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
MPDN+PDN+MTX
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MPDN+PDN
n=47 participants at risk
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
MPDN+PDN+CSA
n=46 participants at risk
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
MPDN+PDN+MTX
n=46 participants at risk
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Subcutaneous abscess
|
2.1%
1/47 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
0.00%
0/46 • 5 years
|
|
Nervous system disorders
Posterior reversible encephalopathy
|
0.00%
0/47 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Nervous system disorders
Convulsion
|
0.00%
0/47 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/47 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/47 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/47 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
0.00%
0/47 • 5 years
|
0.00%
0/46 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dermo-hypodermitis
|
0.00%
0/47 • 5 years
|
0.00%
0/46 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
MPDN+PDN
n=47 participants at risk
MPDN+PDN MPDN= methylprednisolone PDN= prednisone or equivalent
3 MPDN pulse + PDN: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.
|
MPDN+PDN+CSA
n=46 participants at risk
MPDN= methylprednisolone pulse PDN= prednisone or equivalent CSA= cyclosporine A
3 MPDN pulse + PDN + CSA: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses
|
MPDN+PDN+MTX
n=46 participants at risk
MPDN= methylprednisolone pulse PDN= prednisone or equivalent MTX= methotrexate
3 MPDN pulse + PDN + MTX: 3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
10.6%
5/47 • 5 years
|
17.4%
8/46 • 5 years
|
2.2%
1/46 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.1%
1/47 • 5 years
|
23.9%
11/46 • 5 years
|
2.2%
1/46 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.1%
1/47 • 5 years
|
8.7%
4/46 • 5 years
|
4.3%
2/46 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
6.4%
3/47 • 5 years
|
8.7%
4/46 • 5 years
|
8.7%
4/46 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/47 • 5 years
|
15.2%
7/46 • 5 years
|
0.00%
0/46 • 5 years
|
|
Infections and infestations
Infection and infestations
|
10.6%
5/47 • 5 years
|
30.4%
14/46 • 5 years
|
30.4%
14/46 • 5 years
|
|
Endocrine disorders
Cushing syndrome
|
19.1%
9/47 • 5 years
|
13.0%
6/46 • 5 years
|
19.6%
9/46 • 5 years
|
|
Metabolism and nutrition disorders
Weight gain
|
6.4%
3/47 • 5 years
|
2.2%
1/46 • 5 years
|
6.5%
3/46 • 5 years
|
|
Investigations
Increases in serum creatinine
|
0.00%
0/47 • 5 years
|
6.5%
3/46 • 5 years
|
6.5%
3/46 • 5 years
|
|
Nervous system disorders
Headache
|
2.1%
1/47 • 5 years
|
10.9%
5/46 • 5 years
|
2.2%
1/46 • 5 years
|
|
Injury, poisoning and procedural complications
General disorders and administration site conditions
|
2.1%
1/47 • 5 years
|
19.6%
9/46 • 5 years
|
4.3%
2/46 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders
|
2.1%
1/47 • 5 years
|
10.9%
5/46 • 5 years
|
8.7%
4/46 • 5 years
|
|
Psychiatric disorders
Psychiatric disorders
|
4.3%
2/47 • 5 years
|
10.9%
5/46 • 5 years
|
8.7%
4/46 • 5 years
|
|
Metabolism and nutrition disorders
Metabolic disorders
|
6.4%
3/47 • 5 years
|
8.7%
4/46 • 5 years
|
8.7%
4/46 • 5 years
|
|
Vascular disorders
Vascular disorders
|
4.3%
2/47 • 5 years
|
15.2%
7/46 • 5 years
|
2.2%
1/46 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/47 • 5 years
|
6.5%
3/46 • 5 years
|
0.00%
0/46 • 5 years
|
|
Eye disorders
Eye disorders
|
0.00%
0/47 • 5 years
|
6.5%
3/46 • 5 years
|
6.5%
3/46 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place