Trial Outcomes & Findings for Study of Arimoclomol in Inclusion Body Myositis (IBM) (NCT NCT02753530)
NCT ID: NCT02753530
Last Updated: 2023-05-10
Results Overview
Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
Change from Baseline to Month 20
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
Arimoclomol (20 Months)
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
78
|
|
Overall Study
COMPLETED
|
62
|
72
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Arimoclomol (20 Months)
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Baseline characteristics by cohort
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 Years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
67.4 Years
STANDARD_DEVIATION 8.08 • n=7 Participants
|
67.2 Years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age at diagnosis
|
63.4 Years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 7.94 • n=7 Participants
|
63.4 Years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
|
Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score
|
26.88 score on a scale
STANDARD_DEVIATION 4.740 • n=5 Participants
|
27.92 score on a scale
STANDARD_DEVIATION 4.394 • n=7 Participants
|
27.41 score on a scale
STANDARD_DEVIATION 4.581 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Month 20Population: Intention-to-treat; participants with data at Month 20
Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=62 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=72 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score
|
-3.26 score on a scale
Interval -4.15 to -2.36
|
-2.26 score on a scale
Interval -3.11 to -1.41
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12Population: Intention-to-treat; participants with data at Month 12
Measured by rate of decline in the IBMFRS between experimental and placebo groups. The IBMFRS is a 10-item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=63 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=73 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score
|
-1.87 score on a scale
Standard Deviation 3.494
|
-1.03 score on a scale
Standard Deviation 3.127
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Unilateral hand grip strength in both hands measured using the Jamar Dynamometer. Results are for the stronger limb, as identified at baseline.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Grip Strength
Change from Baseline to Month 12
|
-1.09 kg
Standard Deviation 5.459
|
-1.84 kg
Standard Deviation 3.259
|
|
Grip Strength
Change from Baseline to Month 20
|
-3.93 kg
Standard Deviation 9.201
|
-2.86 kg
Standard Deviation 4.741
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
The patient's combined ability to rise from a chair and walk 3 meters, turn around and walk back to the chair and sit down. The test was performed twice and the fastest time was used. The results were expressed as velocity in meters/second.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Modified Timed up and go (mTUG)
Change from Baseline to Month 12
|
-0.075 meters per second (m/sec)
Standard Deviation 0.3048
|
-0.058 meters per second (m/sec)
Standard Deviation 0.2281
|
|
Modified Timed up and go (mTUG)
Change from Baseline to Month 20
|
-0.084 meters per second (m/sec)
Standard Deviation 0.1893
|
-0.104 meters per second (m/sec)
Standard Deviation 0.1955
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
The Manual Muscle Testing (MMT) scores the strength of 24 muscles (axial, proximal, and distal muscles, tested bilaterally) on a scale from 0 to 10 points. The total score is calculated as an average across the 24 muscles and ranges from 0 to 10. The total score will increase if a patient is getting stronger and decrease if a patient is getting weaker.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Manual Muscle Testing (MMT), Total Score
Change from Baseline to Month 12
|
-0.49 score on a scale
Standard Deviation 0.878
|
-0.47 score on a scale
Standard Deviation 0.855
|
|
Manual Muscle Testing (MMT), Total Score
Change from Baseline to Month 20
|
-0.48 score on a scale
Standard Deviation 0.922
|
-0.53 score on a scale
Standard Deviation 0.764
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
The distance patients could walk in 6 minutes. The distance walked in meters was recorded after 6 minutes.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
6 Minute Walk Test (6MWT); Distance After 6 Minutes (6MWD)
Change from Baseline to Month 20
|
-37.0 meters
Standard Deviation 80.09
|
-30.9 meters
Standard Deviation 65.68
|
|
6 Minute Walk Test (6MWT); Distance After 6 Minutes (6MWD)
Change from Baseline to Month 12
|
-16.7 meters
Standard Deviation 56.24
|
-10.7 meters
Standard Deviation 43.65
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The physical component score includes 4 scales of physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), and general health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Short Form-36 (SF-36) Physical Component Score
Change from Baseline to Month 20
|
-1.0 score on a scale (physical component)
Standard Deviation 6.94
|
-3.4 score on a scale (physical component)
Standard Deviation 6.51
|
|
Short Form-36 (SF-36) Physical Component Score
Change from Baseline to Month 12
|
-1.3 score on a scale (physical component)
Standard Deviation 5.39
|
-2.0 score on a scale (physical component)
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Unilateral strength of the knee extensor muscles on both limbs using the MicroFET hand-held dynamometer. Results are for the stronger limb, as identified at baseline.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Maximum Voluntary Isometric Contraction (MVICT) of Quadriceps
Change from Baseline to Month 12
|
-2.59 kg
Standard Deviation 9.357
|
-2.49 kg
Standard Deviation 6.067
|
|
Maximum Voluntary Isometric Contraction (MVICT) of Quadriceps
Change from Baseline to Month 20
|
-6.29 kg
Standard Deviation 12.013
|
-4.67 kg
Standard Deviation 7.885
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
The disability index of the HAQ measures self-reported functional status (disability) including the patient's use of aids or devices and/or help from other persons. The scale is composed of 20 items in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities). Each domain has at least 2 subcategory items, scored on a scale from 0 to 3, and for each of the 8 domains the domain score was the highest score of the involved subcategory scores. The total score reported is an average over 8 domains and scores from at least 6 domains had to be available for the total score to be calculated. The average total score ranges from 0 to 3, and a higher score corresponds to a worsening in functional status.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Change from Baseline to Month 12
|
0.24 score on a scale
Standard Deviation 0.364
|
0.24 score on a scale
Standard Deviation 0.375
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Change from Baseline to Month 20
|
0.33 score on a scale
Standard Deviation 0.399
|
0.33 score on a scale
Standard Deviation 0.472
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
The distance patients could walk in 2 minutes (during the 6 Minute Walk Test) recorded in meters.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
2 Minute Walk Test (2MWT)
Change from Baseline to Month 12
|
-4.73 meters
Standard Deviation 19.355
|
-2.40 meters
Standard Deviation 16.789
|
|
2 Minute Walk Test (2MWT)
Change from Baseline to Month 20
|
-11.18 meters
Standard Deviation 25.551
|
-8.52 meters
Standard Deviation 23.601
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Measured using the Short Form health survey with 36 items (SF-36). The questionnaire measures 8 health concepts which yields 2 summary measures: physical and mental health. The mental component score is composed of energy/fatigue (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and emotional well-being (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100, and the summary measure is calculated as the average score. Higher scores indicate better health status.
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Short Form-36 (SF-36) Mental Component Score
Change from Baseline to Month 12
|
-2.0 score on a scale (mental component)
Standard Deviation 7.00
|
-2.1 score on a scale (mental component)
Standard Deviation 7.47
|
|
Short Form-36 (SF-36) Mental Component Score
Change from Baseline to Month 20
|
-2.5 score on a scale (mental component)
Standard Deviation 9.19
|
-1.3 score on a scale (mental component)
Standard Deviation 7.08
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Patient-reported assessment of the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing) at the time of the assessment. The response options for the impact of IBM were "none" (i.e. no impact), "very mild", "mild", "moderate", "severe", and "very severe".
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=56 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=66 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Patient Global Impression of Severity (PGIS)
Month 12 · None
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 12 · Severe
|
14 Participants
|
10 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 12 · Very severe
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · Very mild
|
2 Participants
|
2 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · Mild
|
8 Participants
|
8 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 12 · Very mild
|
1 Participants
|
3 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 12 · Mild
|
9 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 12 · Moderate
|
31 Participants
|
40 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · None
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · Moderate
|
26 Participants
|
43 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · Severe
|
19 Participants
|
12 Participants
|
|
Patient Global Impression of Severity (PGIS)
Month 20 · Very severe
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Patient-reported assessment of the change from start of study treatment in the impact of IBM on the ability to complete activities of daily living (e.g. dressing, walking, bathing). The response options for change in impact were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved".
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=56 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=66 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
Month 12 · No change
|
12 Participants
|
13 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · Much improved
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · Very much improved
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · Missing
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · Very much worse
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · Much worse
|
10 Participants
|
8 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · A little worse
|
27 Participants
|
43 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · A little improved
|
4 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · Much improved
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · Very much improved
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 12 · Missing
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · Very much worse
|
4 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · Much worse
|
23 Participants
|
16 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · A little worse
|
19 Participants
|
40 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · No change
|
5 Participants
|
6 Participants
|
|
Patient Global Impression of Change (PGIC)
Month 20 · A little improved
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Clinician-reported assessment of the severity of the patient's IBM symptoms at the time of the assessment. The response options were "none", "very mild", "mild", "moderate", "severe", and "very severe"
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=5 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=9 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Moderate
|
2 Participants
|
4 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Severe
|
1 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Mild
|
1 Participants
|
2 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · None
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Very mild
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Mild
|
0 Participants
|
2 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Very severe
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 12 · Missing
|
2 Participants
|
3 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · None
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Very mild
|
1 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Moderate
|
2 Participants
|
2 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Severe
|
1 Participants
|
3 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Very severe
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Severity (CGIS)
Month 20 · Missing
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 12 and Month 20Population: Intention-to-treat; participants with data at Month 12 and Month 20, respectively
Clinician-reported assessment of the change from start of study treatment in the patient's IBM symptoms. The response options for change in IBM were "very much worse", "much worse", "a little worse", "no change", "a little improved", "much improved", and "very much improved".
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=5 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=9 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Clinician Global Impression of Change (CGIC)
Month 12 · Very much worse
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · Much worse
|
1 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · A little worse
|
2 Participants
|
5 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · No change
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · A little improved
|
0 Participants
|
1 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · Much improved
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · Very much improved
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 12 · Missing
|
2 Participants
|
3 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · Very much worse
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · Much worse
|
0 Participants
|
1 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · A little worse
|
3 Participants
|
4 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · No change
|
2 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · A little improved
|
0 Participants
|
1 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · Much improved
|
0 Participants
|
1 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · Very much improved
|
0 Participants
|
0 Participants
|
|
Clinician Global Impression of Change (CGIC)
Month 20 · Missing
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Accumulated number from Baseline to Month 20Population: Intention-to-treat
Falls and near falls registered by the participants in a diary
Outcome measures
| Measure |
Arimoclomol (20 Months)
n=73 Participants
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=77 Participants
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Falls and Near Falls
Falls/year
|
4.8 events (falls or near-falls) per year
Standard Deviation 5.43
|
5.8 events (falls or near-falls) per year
Standard Deviation 11.71
|
|
Falls and Near Falls
Near-falls/year
|
9.1 events (falls or near-falls) per year
Standard Deviation 28.52
|
6.9 events (falls or near-falls) per year
Standard Deviation 17.12
|
Adverse Events
Arimoclomol (20 Months)
Serious events: 11 serious events
Other events: 72 other events
Deaths: 1 deaths
Placebo (20 Months)
Serious events: 18 serious events
Other events: 70 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arimoclomol (20 Months)
n=73 participants at risk
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=78 participants at risk
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Infections and infestations
Bursitis infective
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Chronic hepatitis B
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Influenza
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Head injury
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Syncope
|
2.7%
2/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Loss of consciousness
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Seizure
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Food poisoning
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.4%
1/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
Other adverse events
| Measure |
Arimoclomol (20 Months)
n=73 participants at risk
Arimoclomol base 248 mg 3 times daily for 20 months
|
Placebo (20 Months)
n=78 participants at risk
Matching placebo 3 times daily for 20 months
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
11.0%
8/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
16.7%
13/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Fall
|
9.6%
7/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
7.7%
6/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Laceration
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
10.3%
8/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
9.6%
7/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
6.4%
5/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
9.0%
7/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
7.7%
6/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.7%
2/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
9.0%
7/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.7%
2/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Nasopharyngitis
|
13.7%
10/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
16.7%
13/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
14.1%
11/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Sinusitis
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
7.7%
6/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Bronchitis
|
2.7%
2/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
6.4%
5/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Infections and infestations
Influenza
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
2.6%
2/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Constipation
|
19.2%
14/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
11.5%
9/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Diarrhoea
|
16.4%
12/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
11.5%
9/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Nausea
|
12.3%
9/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Dry mouth
|
9.6%
7/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.5%
15/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
19.2%
15/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.3%
9/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
10.3%
8/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.0%
8/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
7.7%
6/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
9.0%
7/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
2.6%
2/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
2.6%
2/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Investigations
Blood creatinine increased
|
12.3%
9/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Investigations
Weight decreased
|
9.6%
7/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
3.8%
3/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
3.8%
3/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Headache
|
9.6%
7/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Dizziness
|
11.0%
8/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Hypoaesthesia
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Nervous system disorders
Paraesthesia
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.2%
14/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
General disorders
Fatigue
|
11.0%
8/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
3.8%
3/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
General disorders
Oedema peripheral
|
8.2%
6/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
2.6%
2/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Metabolism and nutrition disorders
Alcohol intolerance
|
5.5%
4/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
0.00%
0/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
5.1%
4/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
|
Vascular disorders
Hypertension
|
6.8%
5/73 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
1.3%
1/78 • From first dose of study medication until 14 days following the latest administration of study medication. Assessed monthly for the first 6 months, and then every second month until Month 20.
The safety population included all participants who received any amount of study medication. The safety analysis included all events occurring during the on-treatment observation period which started at the date of first administration of study medication and until 14 days following the latest administration of study medication. The results are similar to those during the in-trial period (from written informed consent until the telephone follow-up visit, 30 days after the end of the trial).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60