Trial Outcomes & Findings for Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients (NCT NCT01201343)
NCT ID: NCT01201343
Last Updated: 2013-12-27
Results Overview
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
79 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2013-12-27
Participant Flow
Participant milestones
| Measure |
Interferon-beta
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
Treated
|
76
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Interferon-beta
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Participant wrongly included in trial
|
1
|
|
Overall Study
Randomized, not treated
|
3
|
Baseline Characteristics
Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Outcome measures
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
Baseline (n= 70)
|
12.7 units on a scale
Standard Deviation 4.4
|
|
Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
Change at Month 12 (n= 57)
|
-0.5 units on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline and Month 18Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Outcome measures
| Measure |
Interferon-beta
n=61 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
|
-0.6 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Baseline and Month 24Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Outcome measures
| Measure |
Interferon-beta
n=63 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
|
-0.1 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)
Outcome measures
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Baseline (n= 70)
|
5.6 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 1 (n= 64)
|
0.3 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 12 (n= 57)
|
-0.0 units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 2 (n= 62)
|
-0.1 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 3 (n= 64)
|
-0.0 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 4 (n= 59)
|
-0.0 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 5 (n= 58)
|
-0.2 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 6 (n= 56)
|
-0.3 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 9 (n= 58)
|
-0.1 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 18 (n= 61)
|
-0.3 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 24 (n= 63)
|
-0.3 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)
Outcome measures
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Baseline (n= 70)
|
35.9 units on a scale
Standard Deviation 11.8
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 1 (n= 65)
|
0.8 units on a scale
Standard Deviation 10.5
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 2 (n= 62)
|
0.3 units on a scale
Standard Deviation 12.3
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 3 (n= 64)
|
-1.7 units on a scale
Standard Deviation 11.5
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 4 (n= 59)
|
-1.5 units on a scale
Standard Deviation 11.0
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 5 (n= 58)
|
-0.8 units on a scale
Standard Deviation 9.2
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 6 (n= 55)
|
-1.4 units on a scale
Standard Deviation 11.5
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 9 (n= 58)
|
-0.2 units on a scale
Standard Deviation 10.5
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 12 (n= 57)
|
-0.3 units on a scale
Standard Deviation 12.7
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 18 (n= 61)
|
-1.2 units on a scale
Standard Deviation 11.2
|
|
Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 24 (n= 63)
|
-1.4 units on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)
Outcome measures
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 6 (n= 56)
|
0.9 units on a scale
Standard Deviation 9.2
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 9 (n= 58)
|
0.9 units on a scale
Standard Deviation 10.7
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Baseline (n= 70)
|
13.5 units on a scale
Standard Deviation 11.1
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 1 (n= 65)
|
1.0 units on a scale
Standard Deviation 8.6
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 2 (n= 62)
|
1.5 units on a scale
Standard Deviation 10.6
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 3 (n= 64)
|
-0.5 units on a scale
Standard Deviation 9.9
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 4 (n= 58)
|
-1.0 units on a scale
Standard Deviation 9.8
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 5 (n= 58)
|
-1.1 units on a scale
Standard Deviation 8.6
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 12 (n= 57)
|
1.6 units on a scale
Standard Deviation 10.8
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 18 (n= 61)
|
-0.2 units on a scale
Standard Deviation 9.0
|
|
Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 24 (n= 63)
|
0.1 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24Population: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.
STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)
Outcome measures
| Measure |
Interferon-beta
n=70 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 5 (n= 58)
|
-0.0 units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 6 (n= 56)
|
1.1 units on a scale
Standard Deviation 7.6
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 9 (n= 58)
|
1.1 units on a scale
Standard Deviation 5.9
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 18 (n= 61)
|
0.8 units on a scale
Standard Deviation 5.4
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 24 (n= 63)
|
1.0 units on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 1 (n= 65)
|
0.0 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Baseline (n= 70)
|
16.8 units on a scale
Standard Deviation 4.1
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 2 (n= 62)
|
1.0 units on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 3 (n= 64)
|
-0.0 units on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 4 (n= 59)
|
-0.3 units on a scale
Standard Deviation 4.7
|
|
Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
Change at Month 12 (n= 57)
|
0.9 units on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 6, 12, and 24Population: ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.
Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)
Outcome measures
| Measure |
Interferon-beta
n=62 Participants
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Baseline (n= 62)
|
2.1 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 1 (n= 58)
|
0.5 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 2 (n= 55)
|
0.4 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 3 (n= 56)
|
0.2 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 6 (n= 50)
|
0.4 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 12 (n= 49)
|
0.1 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Change at Month 24 (n= 56)
|
-0.1 units on a scale
Standard Deviation 2.1
|
Adverse Events
Interferon-beta
Serious events: 9 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon-beta
n=76 participants at risk
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Depression
|
3.9%
3/76 • Number of events 3 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Headache
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Drug Dependence
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Aggressivity
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Suicide Attempt
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Neck Injury
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Other adverse events
| Measure |
Interferon-beta
n=76 participants at risk
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
|
|---|---|
|
Nervous system disorders
Headache
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
52.6%
40/76 • Number of events 40 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Migraine
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Neuralgia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Nystagmus
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Restless Legs Syndrome
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Nervous system disorders
Sciatica
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Influenza Like Illness
|
23.7%
18/76 • Number of events 18 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Fatigue
|
14.5%
11/76 • Number of events 11 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection Site Pain
|
9.2%
7/76 • Number of events 7 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection Site Erythema
|
6.6%
5/76 • Number of events 5 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Irritability
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection Site Haematoma
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Injection Site Reaction
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
General disorders
Pain
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Depression
|
7.9%
6/76 • Number of events 6 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Insomnia
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Depressed Mood
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Emotional Distress
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Mania
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Panic Attack
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Psychiatric disorders
Sleep Disorder
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Bronchitis
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Influenza
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Tonsillitis
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Acarodermatitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Rhinolaryngitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Tracheitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Infections and infestations
Urinary Tract Infection ba
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.3%
4/76 • Number of events 4 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Deafness
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Menlere's Disease
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Cytolytic Hepatitis
|
3.9%
3/76 • Number of events 3 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Gamma-glutamyltransferase
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Investigations
Liver Function Test Abnormal
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
2/76 • Number of events 2 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
|
Vascular disorders
Raynaud's Phenomenon
|
1.3%
1/76 • Number of events 1 • Baseline to Month 24
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER