Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
Brief summary
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.
Detailed description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Interventions
DRUGInterferon beta 1b (Betaseron, BAY86-5046)
250 mcg administered s.c.(subcutaneous) every other day
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated statement of informed consent * Completion of Protocol 307000A * Negative serum pregnancy test results * Agreement to adequate contraception, for female patients
Exclusion criteria
* Pregnancy or lactation * History of alcohol or drug abuse * Inability to administer subcutaneous injections either by self or by caregiver * Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study * Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | At End of Study Visit (week 234) | Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | At End of Study Visit (week 234) | Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml). |
Countries
United States
Participant flow
Recruitment details
Eligible patients for this multi-center study included only those who completed in a predecessor study. Patients were enrolled at the end of the preceding study, from 03 Jun 2003 until 06 Jun 2003. Patients who interrupted study medication in accordance with the investigator were eligible, provided it did not result in premature End of Study (EOS).
Pre-assignment details
For the first 10 weeks of this extension study, patients remained on the IFNB-1b dosage assigned in Study 307000A (Core Treatment). At the Week 10 visit, patients were unblinded by the sponsor and given a choice of drug dosage. They could continue on the original doses, 250 or 500 micrograms, or could change to the other dose (Extension Treatment).
Participants by arm
| Arm | Count |
|---|---|
| ET: IFNB-1b 250 mcg => 250 mcg Extension Treatment 250 mcg continued | 16 |
| ET: IFNB-1b 500 mcg => 250 mcg Extension Treatment 500 mcg reduced to 250 mcg | 6 |
| ET: IFNB-1b 500 mcg => 500 mcg Extension Treatment 500 mcg continued | 19 |
| ET: IFNB-1b 250 mcg => 500 mcg Extension Treatment 250 mcg increased to 500 mcg | 20 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Core Treatment Period (CT) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
| Extension Treatment Period (ET) | Adverse Event | 3 | 0 | 2 | 0 | 0 | 0 |
| Extension Treatment Period (ET) | Lost to Follow-up | 2 | 0 | 1 | 0 | 0 | 0 |
| Extension Treatment Period (ET) | ´Other´ not further itemized | 2 | 3 | 1 | 2 | 0 | 0 |
| Extension Treatment Period (ET) | Withdrawal by Subject | 1 | 1 | 1 | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | ET: IFNB-1b 250 mcg => 500 mcg | Total | ET: IFNB-1b 250 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 250 mcg | ET: IFNB-1b 500 mcg => 500 mcg |
|---|---|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 7.17 | 38.1 years STANDARD_DEVIATION 7.98 | 37.8 years STANDARD_DEVIATION 9.22 | 32.2 years STANDARD_DEVIATION 6.79 | 38.8 years STANDARD_DEVIATION 7.57 |
| Age, Customized >20-30 years | 1 participants | 9 participants | 3 participants | 2 participants | 3 participants |
| Age, Customized >30-40 years | 10 participants | 26 participants | 7 participants | 3 participants | 6 participants |
| Age, Customized >40-50 years | 8 participants | 21 participants | 4 participants | 1 participants | 8 participants |
| Age, Customized >50 years | 1 participants | 5 participants | 2 participants | 0 participants | 2 participants |
| Sex: Female, Male Female | 12 Participants | 44 Participants | 14 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 2 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 16 | 6 / 6 | 19 / 19 | 20 / 20 |
| serious Total, serious adverse events | 2 / 16 | 0 / 6 | 9 / 19 | 4 / 20 |
Outcome results
Primary
Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.
Time frame: At End of Study Visit (week 234)
Population: The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of headache | 2 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of fever | 1 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Lymphocytes) | 2 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ALAT) | 4 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of myalgia | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Leukocytes) | 3 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions | 2 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ASAT) | 2 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of flu-like syndrome | 1 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions pain | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ASAT) | 1 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Leukocytes) | 1 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of asthenia | 4 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Bilirubin total) | 10 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ASAT) | 1 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Leukocytes) | 3 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of myalgia | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions | 3 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions pain | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of asthenia | 1 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of headache | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ALAT) | 1 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of flu-like syndrome | 1 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of fever | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Bilirubin total) | 4 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of fever | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of asthenia | 2 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ASAT) | 8 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of flu-like syndrome | 4 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Lymphocytes) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of myalgia | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions | 4 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions pain | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of headache | 2 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ALAT) | 8 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Bilirubin total) | 10 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Bilirubin total) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Leukocytes) | 4 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Leukocytes) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Lymphocytes) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Hemoglobin) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Hemoglobin) | 1 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Bilirubin total) | 14 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of fever | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Lymphocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Lymphocytes) | 5 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ASAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (ALAT) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ALAT) | 9 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of headache | 3 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of flu-like syndrome | 7 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of asthenia | 3 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions pain | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Platelets) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Hemoglobin) | 1 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of injection site reactions | 3 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of myalgia | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Leukocytes) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Leukocytes) | 2 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (Leukocytes) | 6 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 1 toxicity (ASAT) | 7 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Lymphocytes) | 1 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 4 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Bilirubin total) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 2 toxicity (Hemoglobin) | 0 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities | Incidence of grade 3 toxicity (Lymphocytes) | 1 participants |
Secondary
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).
Time frame: At End of Study Visit (week 234)
Population: For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ET: IFNB-1b 250 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 20 NU/ml (minimum) | 2 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 400 NU/ml (minimum) | 1 participants |
| ET: IFNB-1b 250 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 100 NU/ml (minimum) | 1 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 20 NU/ml (minimum) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 400 NU/ml (minimum) | 0 participants |
| ET: IFNB-1b 500 mcg => 250 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 100 NU/ml (minimum) | 0 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 20 NU/ml (minimum) | 5 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 100 NU/ml (minimum) | 2 participants |
| ET: IFNB-1b 500 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 400 NU/ml (minimum) | 1 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 20 NU/ml (minimum) | 3 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 400 NU/ml (minimum) | 1 participants |
| ET: IFNB-1b 250 mcg => 500 mcg | Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b | NAbs titer, cut-off value 100 NU/ml (minimum) | 2 participants |