Trial Outcomes & Findings for Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis (NCT NCT00235989)
NCT ID: NCT00235989
Last Updated: 2014-05-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
At End of Study Visit (week 234)
Results posted on
2014-05-08
Participant Flow
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).
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).
Participant milestones
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
|
CT: IFNB-1b 250mcg
Core Treatment 250 mcg
|
CT: IFNB-1b 500mcg
Core Treatment 500 mcg
|
|---|---|---|---|---|---|---|
|
Extension Treatment Period (ET)
COMPLETED
|
8
|
2
|
14
|
14
|
0
|
0
|
|
Core Treatment Period (CT)
STARTED
|
0
|
0
|
0
|
0
|
36
|
27
|
|
Core Treatment Period (CT)
COMPLETED
|
0
|
0
|
0
|
0
|
36
|
25
|
|
Core Treatment Period (CT)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Extension Treatment Period (ET)
STARTED
|
16
|
6
|
19
|
20
|
0
|
0
|
|
Extension Treatment Period (ET)
NOT COMPLETED
|
8
|
4
|
5
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
Extension Treatment 250 mcg increased to 500 mcg
|
CT: IFNB-1b 250mcg
Core Treatment 250 mcg
|
CT: IFNB-1b 500mcg
Core Treatment 500 mcg
|
|---|---|---|---|---|---|---|
|
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)
Withdrawal by Subject
|
1
|
1
|
1
|
4
|
0
|
0
|
|
Extension Treatment Period (ET)
´Other´ not further itemized
|
2
|
3
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
n=16 Participants
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
n=6 Participants
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
n=19 Participants
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
n=20 Participants
Extension Treatment 250 mcg increased to 500 mcg
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 6.79 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 7.17 • n=4 Participants
|
38.1 years
STANDARD_DEVIATION 7.98 • n=21 Participants
|
|
Age, Customized
>20-30 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Age, Customized
>30-40 years
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Age, Customized
>40-50 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Age, Customized
>50 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
n=16 Participants
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
n=6 Participants
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
n=19 Participants
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
n=20 Participants
Extension Treatment 250 mcg increased to 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
|
1 participants
|
1 participants
|
4 participants
|
7 participants
|
|
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
|
0 participants
|
1 participants
|
0 participants
|
|
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
|
0 participants
|
1 participants
|
0 participants
|
|
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
|
3 participants
|
4 participants
|
3 participants
|
|
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
|
0 participants
|
1 participants
|
0 participants
|
|
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
|
1 participants
|
2 participants
|
3 participants
|
|
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
|
0 participants
|
2 participants
|
3 participants
|
|
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
|
1 participants
|
8 participants
|
9 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
1 participants
|
8 participants
|
7 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
4 participants
|
10 participants
|
14 participants
|
|
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
|
0 participants
|
1 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
3 participants
|
4 participants
|
6 participants
|
|
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
|
0 participants
|
1 participants
|
2 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
1 participants
|
5 participants
|
|
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
|
0 participants
|
1 participants
|
1 participants
|
|
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
|
0 participants
|
0 participants
|
1 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
1 participants
|
1 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
|
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
|
0 participants
|
1 participants
|
0 participants
|
|
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
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
n=8 Participants
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
n=2 Participants
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
n=15 Participants
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
n=15 Participants
Extension Treatment 250 mcg increased to 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)
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
|
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
|
0 participants
|
5 participants
|
3 participants
|
|
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
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
ET: IFNB-1b 250 mcg => 250 mcg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
ET: IFNB-1b 500 mcg => 250 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ET: IFNB-1b 500 mcg => 500 mcg
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
ET: IFNB-1b 250 mcg => 500 mcg
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
n=16 participants at risk
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
n=6 participants at risk
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
n=19 participants at risk
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
n=20 participants at risk
Extension Treatment 250 mcg increased to 500 mcg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Chills
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Fever
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Necrosis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Sepsis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Cerebral Ischemia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Cerebrovascular Accident
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Cardiac disorders
Myocardial Infarct
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Vascular disorders
Occlusion
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Cardiac disorders
Pericarditis
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Rectal Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Joint Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Nervous system disorders
Headache
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Lung Edema
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Otitis Media
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Endometrial Disorder
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Kidney Calculus
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
Other adverse events
| Measure |
ET: IFNB-1b 250 mcg => 250 mcg
n=16 participants at risk
Extension Treatment 250 mcg continued
|
ET: IFNB-1b 500 mcg => 250 mcg
n=6 participants at risk
Extension Treatment 500 mcg reduced to 250 mcg
|
ET: IFNB-1b 500 mcg => 500 mcg
n=19 participants at risk
Extension Treatment 500 mcg continued
|
ET: IFNB-1b 250 mcg => 500 mcg
n=20 participants at risk
Extension Treatment 250 mcg increased to 500 mcg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16
|
16.7%
1/6
|
15.8%
3/19
|
5.0%
1/20
|
|
Infections and infestations
Abscess
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
6.2%
1/16
|
0.00%
0/6
|
21.1%
4/19
|
15.0%
3/20
|
|
Immune system disorders
Allergic Reaction
|
6.2%
1/16
|
0.00%
0/6
|
15.8%
3/19
|
10.0%
2/20
|
|
General disorders
Ashthenia
|
25.0%
4/16
|
16.7%
1/6
|
10.5%
2/19
|
15.0%
3/20
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
2/16
|
0.00%
0/6
|
5.3%
1/19
|
10.0%
2/20
|
|
General disorders
Chills
|
0.00%
0/16
|
0.00%
0/6
|
15.8%
3/19
|
0.00%
0/20
|
|
General disorders
Cyst
|
6.2%
1/16
|
0.00%
0/6
|
15.8%
3/19
|
5.0%
1/20
|
|
General disorders
Face Edema
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Fever
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Infections and infestations
Flu Syndrom
|
6.2%
1/16
|
16.7%
1/6
|
21.1%
4/19
|
35.0%
7/20
|
|
Musculoskeletal and connective tissue disorders
Heaviness in Extremities
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
General disorders
Hernia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Investigations
Hormone Level altered
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Infections and infestations
Infection
|
12.5%
2/16
|
0.00%
0/6
|
10.5%
2/19
|
15.0%
3/20
|
|
Investigations
Laboratory Test abnormal
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
General disorders
Malaise
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Pain
|
12.5%
2/16
|
33.3%
2/6
|
21.1%
4/19
|
25.0%
5/20
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
18.8%
3/16
|
0.00%
0/6
|
26.3%
5/19
|
15.0%
3/20
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
10.0%
2/20
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Cerebral Infarct
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Chest Pain
|
6.2%
1/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Vascular disorders
Hypertension
|
12.5%
2/16
|
0.00%
0/6
|
10.5%
2/19
|
15.0%
3/20
|
|
Nervous system disorders
Migraine
|
6.2%
1/16
|
0.00%
0/6
|
21.1%
4/19
|
0.00%
0/20
|
|
Cardiac disorders
Pericarditis
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Syncope
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Vascular disorders
Vascular Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16
|
16.7%
1/6
|
5.3%
1/19
|
10.0%
2/20
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16
|
0.00%
0/6
|
15.8%
3/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16
|
0.00%
0/6
|
5.3%
1/19
|
20.0%
4/20
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16
|
0.00%
0/6
|
15.8%
3/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Ginigivitis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Gum Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Increased Salivation
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16
|
0.00%
0/6
|
21.1%
4/19
|
15.0%
3/20
|
|
Gastrointestinal disorders
Rectal Bleeding
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Infections and infestations
Peridontal Abscess
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Rectal Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
10.0%
2/20
|
|
Gastrointestinal disorders
Tongue Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Gastrointestinal disorders
Tooth Caries
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Tooth Disorder
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Endocrine disorders
Adrenal Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Endocrine disorders
Goiter
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Endocrine disorders
Hypothyreodism
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
5.0%
1/20
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
5.0%
1/20
|
|
Investigations
Decreased Hemoglobin
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
10.0%
2/20
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
15.0%
3/20
|
|
Blood and lymphatic system disorders
Normocytic Anemia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Investigations
Platelet Count decreased
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Injection Site Abscess
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Injection Site Necrosis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
General disorders
Injection Site Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
General disorders
Injection Site Reaction
|
12.5%
2/16
|
50.0%
3/6
|
21.1%
4/19
|
15.0%
3/20
|
|
Metabolism and nutrition disorders
Avitaminosis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
General disorders
Edema
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Investigations
Gamma-GT increased
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
15.0%
3/20
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
6.2%
1/16
|
0.00%
0/6
|
15.8%
3/19
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
General disorders
Peripheral Edema
|
6.2%
1/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Investigations
SGOT increased
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Investigations
SGPT increased
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
10.0%
2/20
|
|
Renal and urinary disorders
Uremia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Investigations
Weight Gain
|
12.5%
2/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Investigations
Weight Loss
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
15.0%
3/20
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Bone Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
10.0%
2/20
|
|
Injury, poisoning and procedural complications
Bone Fracture (not spontaneous)
|
12.5%
2/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Joint Disorder
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
18.8%
3/16
|
0.00%
0/6
|
10.5%
2/19
|
10.0%
2/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myasthenia
|
18.8%
3/16
|
33.3%
2/6
|
15.8%
3/19
|
35.0%
7/20
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Twitching
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
General disorders
Abnormal Gait
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
10.0%
2/20
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16
|
16.7%
1/6
|
10.5%
2/19
|
10.0%
2/20
|
|
Nervous system disorders
Ataxia
|
25.0%
4/16
|
0.00%
0/6
|
5.3%
1/19
|
10.0%
2/20
|
|
Psychiatric disorders
Confusion
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Psychiatric disorders
Depression
|
25.0%
4/16
|
50.0%
3/6
|
21.1%
4/19
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
|
0.00%
0/6
|
15.8%
3/19
|
10.0%
2/20
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Psychiatric disorders
Emotional Lability
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Foot Drop
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
12.5%
2/16
|
0.00%
0/6
|
10.5%
2/19
|
15.0%
3/20
|
|
Vascular disorders
Hot Flashes
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Hypalgesia
|
6.2%
1/16
|
0.00%
0/6
|
15.8%
3/19
|
0.00%
0/20
|
|
Nervous system disorders
Hyperkinesia
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Hypertonia
|
18.8%
3/16
|
0.00%
0/6
|
15.8%
3/19
|
5.0%
1/20
|
|
Nervous system disorders
Hypesthesia
|
31.2%
5/16
|
50.0%
3/6
|
36.8%
7/19
|
45.0%
9/20
|
|
Nervous system disorders
Incoordination
|
12.5%
2/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16
|
16.7%
1/6
|
15.8%
3/19
|
20.0%
4/20
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Multiple Sclerosis
|
25.0%
4/16
|
50.0%
3/6
|
10.5%
2/19
|
30.0%
6/20
|
|
Psychiatric disorders
Nervousness
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
10.0%
2/20
|
|
Nervous system disorders
Neuropathy
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Nystagmus
|
12.5%
2/16
|
0.00%
0/6
|
5.3%
1/19
|
15.0%
3/20
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Nervous system disorders
Paresthesia
|
31.2%
5/16
|
50.0%
3/6
|
36.8%
7/19
|
25.0%
5/20
|
|
Nervous system disorders
Reflexes decreased
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Nervous system disorders
Reflexes increased
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Nervous system disorders
Somnolence
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Nervous system disorders
Tremor
|
6.2%
1/16
|
16.7%
1/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
2/16
|
0.00%
0/6
|
0.00%
0/19
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Bronchitis
|
25.0%
4/16
|
16.7%
1/6
|
15.8%
3/19
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Septum Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
15.0%
3/20
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Sinusitis
|
12.5%
2/16
|
16.7%
1/6
|
26.3%
5/19
|
25.0%
5/20
|
|
Infections and infestations
Upper Respiratory Infection
|
31.2%
5/16
|
16.7%
1/6
|
10.5%
2/19
|
35.0%
7/20
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Female Lactation
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Fungal Dermatitis
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Petechial Rash
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Benign Neoplasm
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
15.0%
3/20
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Eye disorders
Blurred Vision
|
12.5%
2/16
|
0.00%
0/6
|
10.5%
2/19
|
25.0%
5/20
|
|
Ear and labyrinth disorders
Deafness
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Eye disorders
Diplopia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Ear Disorder
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Ear and labyrinth disorders
Ear Pain
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Eye disorders
Eye Disorder
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Eye disorders
Eye Pain
|
0.00%
0/16
|
0.00%
0/6
|
15.8%
3/19
|
5.0%
1/20
|
|
Nervous system disorders
Optic Neuritis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Infections and infestations
Otitis Media
|
6.2%
1/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Eye disorders
Ptosis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Eye disorders
Pupillary Disorder
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Eye disorders
Refraction Disorder
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Eye disorders
Retinal Disorder
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Nervous system disorders
Taste Perversion
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Nervous system disorders
Visual Field Defect
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Cystitis
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Genital Leukoplakia
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Impotence
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
6.2%
1/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Kidney Calculus
|
0.00%
0/16
|
0.00%
0/6
|
10.5%
2/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Leukorrhea
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Investigations
Papanicolaou Smear suspicious
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Infections and infestations
Urethritis
|
0.00%
0/16
|
16.7%
1/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
10.0%
2/20
|
|
Renal and urinary disorders
Urinary Retention
|
6.2%
1/16
|
0.00%
0/6
|
0.00%
0/19
|
0.00%
0/20
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
4/16
|
0.00%
0/6
|
31.6%
6/19
|
15.0%
3/20
|
|
Renal and urinary disorders
Urinary Urgency
|
6.2%
1/16
|
16.7%
1/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Renal and urinary disorders
Urination impaired
|
0.00%
0/16
|
16.7%
1/6
|
5.3%
1/19
|
5.0%
1/20
|
|
Infections and infestations
Vaginitis
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Vulvovaginal Disorder
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma
|
0.00%
0/16
|
0.00%
0/6
|
5.3%
1/19
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16
|
0.00%
0/6
|
0.00%
0/19
|
5.0%
1/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place