Trial Outcomes & Findings for A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome (NCT NCT00287079)
NCT ID: NCT00287079
Last Updated: 2013-12-27
Results Overview
CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
35 participants
Primary outcome timeframe
Up to Week 96
Results posted on
2013-12-27
Participant Flow
Participant milestones
| Measure |
Rebif 44 Mcg
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
3
|
|
Overall Study
COMPLETED
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
22
|
1
|
Reasons for withdrawal
| Measure |
Rebif 44 Mcg
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Overall Study
Qualifying relapse
|
12
|
1
|
|
Overall Study
Non-qualifying relapse
|
1
|
0
|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other
|
3
|
0
|
Baseline Characteristics
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
Baseline characteristics by cohort
| Measure |
Rebif 44 Mcg
n=32 Participants
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
n=3 Participants
Participants in this group did not receive any treatment.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.30 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
35.30 years
STANDARD_DEVIATION 13.32 • n=7 Participants
|
35.80 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.
CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
Outcome measures
| Measure |
Rebif 44 Mcg
n=30 Participants
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
n=3 Participants
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
|
15.6 Month
Standard Error 1.23
|
17.0 Month
Standard Error NA
Standard Error not analyzed due to limited number of participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.
CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.
Outcome measures
| Measure |
Rebif 44 Mcg
n=32 Participants
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
n=3 Participants
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
|
37.5 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for "No Treatment" group.
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
Outcome measures
| Measure |
Rebif 44 Mcg
n=32 Participants
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
|
100 percentage of participants
|
—
|
Adverse Events
Rebif 44 Mcg
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rebif 44 Mcg
n=32 participants at risk
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Mild Leucopenia
|
3.1%
1/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
Other adverse events
| Measure |
Rebif 44 Mcg
n=32 participants at risk
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
|
No Treatment
Participants in this group did not receive any treatment.
|
|---|---|---|
|
Eye disorders
Visual Disturbance
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Gastrointestinal disorders
Nausea
|
31.2%
10/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Gastrointestinal disorders
Stomach Discomfort
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Chills
|
50.0%
16/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Fatigue
|
53.1%
17/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Influenza like illness
|
21.9%
7/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Injection site bruising
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Injection site discomfort
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Injection site erythema
|
15.6%
5/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Injection site irritation
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Injection site pain
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Pain
|
37.5%
12/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
General disorders
Pyrexia
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Infections and infestations
Influenza
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Infections and infestations
Nasopharyngitis
|
28.1%
9/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Balance Disorder
|
9.4%
3/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Dysaesthesia
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Headache
|
71.9%
23/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Nervous system disorders
Paraesthesia
|
15.6%
5/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
2/32 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
—
0/0 • Up to Week 96
AE: any untoward medical occurrence in 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. AE were not captured for "No Treatment" group.
|
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