Trial Outcomes & Findings for A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease (NCT NCT01075763)
NCT ID: NCT01075763
Last Updated: 2014-02-13
Results Overview
ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).
COMPLETED
PHASE2
42 participants
Baseline and Week 52
2014-02-13
Participant Flow
Participant milestones
| Measure |
Rebif 22 Mcg
Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Rebif 22 Mcg
Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Rebif 22 Mcg
n=23 Participants
Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=19 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.00 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
64.58 years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
63.71 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score
Baseline
|
18.63 units on a scale
Standard Deviation 7.86
|
19.81 units on a scale
Standard Deviation 6.15
|
|
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score
Week 52
|
20.66 units on a scale
Standard Deviation 9.55
|
20.33 units on a scale
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: Week 12 and 28Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score
Week 12
|
16.74 units on a scale
Standard Deviation 6.94
|
17.97 units on a scale
Standard Deviation 6.28
|
|
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score
Week 28
|
18.49 units on a scale
Standard Deviation 8.72
|
17.55 units on a scale
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
MMSE is a tool for screening cognitive decline associated with dementia. It is a brief examination intended to evaluate an adult participant's level of cognitive functioning. The test is performed in following areas: orientation in time and place, learning and immediate recall, mental control and concentration, short-term recall, naming ability, language expression, verbal comprehension, writing comprehension, writing ability and visual-spatial coordination. Scores range between 0 (maximum cognitive deficit) and 30 (no cognitive deficit).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Mini Mental Status Examination (MMSE) Score
Baseline
|
23.46 units on a scale
Standard Deviation 2.14
|
22.93 units on a scale
Standard Deviation 1.79
|
|
Mini Mental Status Examination (MMSE) Score
Week 12
|
24.50 units on a scale
Standard Deviation 3.22
|
24.66 units on a scale
Standard Deviation 3.14
|
|
Mini Mental Status Examination (MMSE) Score
Week 28
|
24.25 units on a scale
Standard Deviation 3.37
|
23.66 units on a scale
Standard Deviation 4.92
|
|
Mini Mental Status Examination (MMSE) Score
Week 52
|
22.43 units on a scale
Standard Deviation 5.33
|
21.98 units on a scale
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
ADAS-NonCog is a subscale of ADAS aimed to evaluate the non-cognitive features such as mood state and behavioral changes. It takes about 10 minutes to be performed and includes 10 items: testing tearful, depressed mood, concentration/distractibility, uncooperative to testing, delusions, hallucinations, pacing, motor activity increase, tremors and appetite change. Scores range between 0 (excellent performance) and 35 (worst performance).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score
Baseline
|
4.37 units on a scale
Standard Deviation 4.13
|
6.07 units on a scale
Standard Deviation 5.01
|
|
Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score
Week 12
|
3.53 units on a scale
Standard Deviation 3.24
|
4.73 units on a scale
Standard Deviation 4.27
|
|
Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score
Week 28
|
4.63 units on a scale
Standard Deviation 4.36
|
5.20 units on a scale
Standard Deviation 3.43
|
|
Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score
Week 52
|
5.47 units on a scale
Standard Deviation 5.17
|
7.20 units on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Baseline, Week 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
IADL is used to evaluate participants with early-stage disease, both to assess level of disease and to determine participant's ability of self-care. IADL scale measures functional impact of emotional, cognitive, and physical impairments. It provides information about participants' compromising rate and care he might need. It includes 8 items: testing ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medication and ability to handle finances. Scores range between 0 (impairment) and 8 (full independence).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Instrumental Activities of Daily Living (IADL) Score
Baseline
|
6.11 units on a scale
Standard Deviation 1.45
|
6.20 units on a scale
Standard Deviation 1.57
|
|
Instrumental Activities of Daily Living (IADL) Score
Week 28
|
5.84 units on a scale
Standard Deviation 1.17
|
5.60 units on a scale
Standard Deviation 1.68
|
|
Instrumental Activities of Daily Living (IADL) Score
Week 52
|
4.89 units on a scale
Standard Deviation 1.85
|
5.67 units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Baseline, Week 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
PSMS designed as a disability measure for use in planning and evaluating treatment in elderly participants living in community or in institutions, is Guttman scale containing 6 items of self-care. The scale is based on theory that human behavior can be ordered in a hierarchy of complexity, within each category, a further hierarchy of complexity runs from basic to complex activities. It includes 6 items, testing the following areas: toilet use, eating, dressing, physical appearance, deambulation and bath. Scores range between 0 (excellent performance) and 30 (worst performance).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Physical Self-Maintenance Scale (PSMS) Score
Baseline
|
6.42 units on a scale
Standard Deviation 1.02
|
6.40 units on a scale
Standard Deviation 0.91
|
|
Physical Self-Maintenance Scale (PSMS) Score
Week 28
|
6.74 units on a scale
Standard Deviation 1.37
|
7.00 units on a scale
Standard Deviation 2.65
|
|
Physical Self-Maintenance Scale (PSMS) Score
Week 52
|
7.79 units on a scale
Standard Deviation 3.34
|
6.87 units on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: Week 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
CIBIC-PLUS: structured instrument based on comprehensive evaluation of 3 domains: participant cognition, behavior and functioning, including assessment of daily living activities. It includes 15 items and represents assessment of skilled clinician using validated scales based on the observation at interviews conducted separately with participant and caregiver familiar with behavior of participant. According to comparison between baseline and follow-up assessments, scores can range between 1 (markedly improved) and 7 (markedly worsened), with 4 indicating no change observed between two visits.
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 1
|
1 participants
|
0 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 2
|
0 participants
|
2 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 3
|
7 participants
|
6 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 4
|
8 participants
|
5 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 5
|
3 participants
|
0 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 6
|
0 participants
|
2 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 28: CIBIC-PLUS Score 7
|
0 participants
|
0 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 1
|
0 participants
|
0 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 2
|
0 participants
|
2 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 3
|
6 participants
|
2 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 4
|
7 participants
|
4 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 5
|
1 participants
|
4 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 6
|
4 participants
|
3 participants
|
|
Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score
Week 52: CIBIC-PLUS Score 7
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
The GDS consists of 30 'yes' or 'no' items aimed to assess depression. One point is assigned to each answer and the cumulative score is rated on a scoring grid. Scores are grouped as follows: 0-9 'normal', 10-19 'mildly depressed', and 20-30 'severely depressed'.
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Geriatric Depression Scale (GDS) Score
Baseline
|
10.11 units on a scale
Standard Deviation 6.13
|
10.67 units on a scale
Standard Deviation 6.53
|
|
Geriatric Depression Scale (GDS) Score
Week 28
|
9.68 units on a scale
Standard Deviation 5.74
|
9.07 units on a scale
Standard Deviation 4.32
|
|
Geriatric Depression Scale (GDS) Score
Week 52
|
10.79 units on a scale
Standard Deviation 5.93
|
7.50 units on a scale
Standard Deviation 5.56
|
SECONDARY outcome
Timeframe: Baseline, Week 28 and 52Population: Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.
Global deterioration scale includes seven different diagnostic stages ranging between "no cognitive deterioration" and "very serious cognitive deterioration". It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline).
Outcome measures
| Measure |
Rebif 22 Mcg
n=19 Participants
Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=15 Participants
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Global Deterioration Scale Score
Baseline
|
3.00 units on a scale
Standard Deviation 0.47
|
2.87 units on a scale
Standard Deviation 0.74
|
|
Global Deterioration Scale Score
Week 28
|
3.05 units on a scale
Standard Deviation 0.78
|
3.00 units on a scale
Standard Deviation 0.93
|
|
Global Deterioration Scale Score
Week 52
|
3.26 units on a scale
Standard Deviation 0.81
|
3.20 units on a scale
Standard Deviation 1.08
|
Adverse Events
Rebif 22 Mcg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rebif 22 Mcg
n=23 participants at risk
Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
|
Placebo
n=19 participants at risk
Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Articular Pain
|
0.00%
0/23 • Baseline to Week 52
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.
|
10.5%
2/19 • Baseline to Week 52
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
Fever
|
4.3%
1/23 • Baseline to Week 52
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.
|
0.00%
0/19 • Baseline to Week 52
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
High Cholesterol
|
13.0%
3/23 • Baseline to Week 52
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.
|
0.00%
0/19 • Baseline to Week 52
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
High level of alanine transaminase (ALT) and aspartate aminotransferase (AST)
|
4.3%
1/23 • Baseline to Week 52
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.
|
0.00%
0/19 • Baseline to Week 52
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
High level of aspartate aminotransferase (AST) - alanine transaminase (ALT)
|
0.00%
0/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
High pseudocholinesterase
|
8.7%
2/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
High triglycerides
|
4.3%
1/23 • Baseline to Week 52
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.
|
0.00%
0/19 • Baseline to Week 52
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
High thyroid stimulating hormone
|
0.00%
0/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
Low blood pressure
|
0.00%
0/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
Repolarization ventricular anomaly
|
4.3%
1/23 • Baseline to Week 52
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.
|
0.00%
0/19 • Baseline to Week 52
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
Right ear buzzing
|
0.00%
0/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
Flu-like syndrome
|
0.00%
0/23 • Baseline to Week 52
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.
|
5.3%
1/19 • Baseline to Week 52
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER