Tablee-1

Summary of Treatment-emergent Adverse Events Reported in ≥5% of Subjects Overall (All HLA DR Haplotypes): Safety Population

Treatment
Placebo / MBP8298 / Total
Preferred Term / n (%) / n (%) / n (%) / p-value
CONSTIPATION / 23 ( 7.5) / 22 ( 7.2) / 45 ( 7.4) / 0.878
INJECTION SITE PAIN / 26 ( 8.5) / 89 (29.0) / 15 (18.8) / <.001
INJECTION SITE ERYTHEMA / 3 ( 1.0) / 46 (15.0) / 49 ( 8.0) / <.001
FATIGUE / 53 (17.4) / 43 (14.0) / 96 (15.7) / 0.268
INJECTION SITE IRRITATION / 7 ( 2.3) / 28 ( 9.1) / 35 ( 5.7) / <.001
OEDEMA PERIPHERAL / 19 ( 6.2) / 28 ( 9.1) / 47 ( 7.7) / 0.224
ASTHENIA / 18 ( 5.9) / 13 ( 4.2) / 31 ( 5.1) / 0.363
NASOPHARYNGITIS / 61 (20.0) / 66 (21.5) / 127 (20.8) / 0.69
URINARY TRACT INFECTION / 68 (22.3) / 63 (20.5) / 131 (21.4) / 0.623
INFLUENZA / 28 ( 9.2) / 26 ( 8.5) / 54 ( 8.8) / 0.777
UPPER RESPIRATORY TRACT INFECTION / 24 ( 7.9) / 23 ( 7.5) / 47 ( 7.7) / 0.88
FALL / 66 (21.6) / 63 (20.5) / 129 (21.1) / 0.767
CONTUSION / 17 ( 5.6) / 17 ( 5.5) / 34 ( 5.6) / 1
MUSCULAR WEAKNESS / 54 (17.7) / 53 (17.3) / 107 (17.5) / 0.915
ARTHRALGIA / 34 (11.1) / 42 (13.7) / 76 (12.4) / 0.391
PAIN IN EXTREMITY / 37 (12.1) / 25 ( 8.1) / 62 (10.1) / 0.109
MUSCULOSKELETAL STIFFNESS / 15 ( 4.9) / 23 ( 7.5) / 38 ( 6.2) / 0.241
BACK PAIN / 47 (15.4) / 21 ( 6.8) / 68 (11.1) / <.001
MUSCLE SPASMS / 25 ( 8.2) / 21 ( 6.8) / 46 ( 7.5) / 0.543
MULTIPLE SCLEROSIS RELAPSE / 69 (22.6) / 70 (22.8) / 139 (22.7) / 1
HEADACHE / 27 ( 8.9) / 31 (10.1) / 58 ( 9.5) / 0.679
HYPOAESTHESIA / 20 ( 6.6) / 25 ( 8.1) / 45 ( 7.4) / 0.536
MUSCLE SPASTICITY / 20 ( 6.6) / 25 ( 8.1) / 45 ( 7.4) / 0.536
DIZZINESS / 15 ( 4.9) / 23 ( 7.5) / 38 ( 6.2) / 0.241
BALANCE DISORDER / 22 ( 7.2) / 18 ( 5.9) / 40 ( 6.5) / 0.518
DEPRESSION / 35 (11.5) / 32 (10.4) / 67 (10.9) / 0.699
INSOMNIA / 17 ( 5.6) / 16 ( 5.2) / 33 ( 5.4) / 0.86
RASH / 15 ( 4.9) / 21 ( 6.8) / 36 ( 5.9) / 0.391
FLUSHING / 6 ( 2.0) / 25 ( 8.1) / 31 ( 5.1) / <.001
Note 1: If a subject experienced more than one episode of an adverse event, he/she is counted only once within a preferred term. If a subject experienced more than one adverse event within a system organ class, the subject is counted only once for number of subjects.
Note 2: System Organ Class terms are sorted using alphabetical order and Preferred Terms are sorted in decreasing frequency based on the number of MBP8298 subjects with AE reports.
Note 3: MedDRA Dictionary (Version 11.0) was used for coding.
Note 4: P-value is based on Fisher’s exact test.
TEAE = treatment-emergent adverse event