Table 4.
Adverse events.
| Baseline through Month 24 f | ||
|---|---|---|
| Mild-Moderate No. of patients (%) |
Severe No. of patients (%) |
|
| Serious adverse event | ||
| Brain Abscess | 0 (0) | 1 (1.8) |
| Deep vein thrombosis | 0 (0) | 1 (1.8) |
| Empyema a | 0 (0) | 1 (1.8) |
| Gangrenous appendicitis, ruptured | 0 (0) | 1 (1.8) |
| Obstructive hydrocephalus | 0 (0) | 1 (1.8) |
| Pleural effusion a | 0 (0) | 1 (1.8) |
| Pneumonia | 0 (0) | 1 (1.8) |
| Pulmonary embolism | 0 (0) | 1 (1.8) |
| Pyelonephritis | 1 (1.8) | 0 (0) |
| Right pneumothorax | 0 (0) | 1 (1.8) |
| Seizures | 0 (0) | 1 (1.8) |
| Squamous cell carcinoma | 0 (0) | 1 (1.8) |
| Subfalcial herniation | 0 (0) | 1 (1.8) |
| Adverse events with 5 or more patients | ||
| Hair thinning/loss | 20 (36.4) | 0 (0) |
| Diarrhea b , c /loose stool d | 18 (32.7) | 1 (1.8) |
| Headache | 13 (23.6) | 0 (0) |
| Nausea/vomiting | 12 (21.8) | 0 (0) |
| Upper respiratory infection | 11 (20.0) | 0 (0) |
| Vertigo/balance difficulty/dizziness | 11 (20.0) | 0 (0) |
| Fatigue | 10 (18.2) | 0 (0) |
| Tingling/paresthesia | 10 (18.2) | 0 (0) |
| Cognitive changes | 9 (16.4) | 0 (0) |
| Extremity joint pain | 9 (16.4) | 0 (0) |
| Depression | 7 (12.7) | 1 (1.8) |
| Elevated transaminases | 8 (14.6) | 0 (0) |
| Other infections | 8 (14.6) | 0 (0) |
| Rashes/eczema | 8 (14.6) | 0 (0) |
| Sensory decrease/disturbance | 8 (14.6) | 0 (0) |
| Urinary tract infection | 8 (14.6) | 0 (0) |
| Anxiety | 7 (12.7) | 0 (0) |
| Ophthalmic changes | 7 (12.7) | 0 (0) |
| Abdominal pain/discomfort | 6 (10.9) | 0 (0) |
| Back pain | 6 (10.9) | 0 (0) |
| Decreased appetite | 5 (9.1) | 0 (0) |
| Gastrointestinal urgency/incontinence | 5 (9.1) | 0 (0) |
| Heartburn | 5 (9.1) | 0 (0) |
| Hypertension | 5 (9.1) | 0 (0) |
| Migraine | 3 (5.5) | 2 (3.6) |
| Stiffness/spasticity | 5 (9.1) | 0 (0) |
| Weakness/heaviness | 5 (9.1) | 0 (0) |
| Additional adverse events causing TFM withdrawal | ||
| Abscessed tooth, left molar e | 1 (1.8) | 0 (0) |
| Dental infection secondary to implant e | 1 (1.8) | 0 (0) |
| Leukopenia e | 1 (1.8) | 0 (0) |
| Lymphopenia a | 1 (1.8) | 0 (0) |
Percentages are based on total # of enrolled patients (N = 55). All AEs (N = 386) reported for those who experienced AEs during the study period (N = 51). Relapse and progression of MS were not reported as AEs, as these were categorized separately for reporting in table 2.
a
One patient discontinued due to severe empyema, severe pleural effusion, and mild-moderate lymphopenia.
b
One patient discontinued due to mild diarrhea.
c
One patient discontinued due to severe diarrhea.
d
One patient discontinued due to mild loose stool.
e
One patient discontinued due to mild-moderate leukopenia, abscessed tooth and dental infection.
f
AEs collected between July 2013 and August 2017 are included and have been previously reported. 1 .