TABLE 2.
Adverse Events by Body Site
| Body System | N = 49 |
|---|---|
| % (n) | |
| Gastrointestinal | |
| Diarrhea | 44.9% (22) |
| Rectal Bleeding | 16.3% (8) |
| Abdominal Painc, d | 26.5 (13) |
| Nausea | 10.2% (5) |
| Vomiting | 6.1% (3) |
| Heart Burn | 4.1% (2) |
| Constipation | 2% (1) |
| Rectal Abscess | 2% (1) |
| Right lower Quadrant Pain | 2% (1) |
| Gastritis | 2% (1) |
| Bloating | 2% (1) |
| Discoloured Stool | 2% (1) |
| IBD flarea | 2% (1) |
| Systemic | |
| Fever | 10.2% (5) |
| Fatigue | 6.1% (3) |
| Chills | 4.1% (2) |
| Night sweats | 2% (1) |
| Anemiab | 2% (1) |
| Burning pain on feet | 2% (1) |
| Pedal bilateral edema | 2% (1) |
| Respiratory | |
| Cough | 2% (1) |
| Dermatologic | |
| Shingles | 2% (1) |
| Eczema | 2% (1) |
| Cyst | 2% (1) |
| Swollen lymph nodes | 2% (1) |
| Rash | 2% (1) |
| Polymorphous light eruption | 2% (1) |
| Skin abscess | 2% (1) |
| Neurological | |
| Migraine | 4.1% (2) |
| Genitourinary | |
| Yeast infection | 4.1% (2) |
| Kidney stones | 2% (1) |
| Musculoskeletal | |
| Muscle soreness | 2% (1) |
| Back pain | 2% (1) |
| Infection | |
| Oral infection | 2% (1) |
| Pharyngitis | 2% (1) |
aGrade 3 IBD flare that resulted in a hospitalization in 1 subject reported during the week 8 follow-up. Subject was treated with Remicade and discharged from hospital.
bSubject with anemia required blood transfusions and reported the event during their week 8 follow-up. The event was deemed to be disease-related not treatment-related; it was resolved with transfusion.
cSubject went to ER for general GI pain and reported the event during their week 26 follow-up. Subject was given Percocet to take as needed.
dOne subject visited the ER due to abdominal pain and reported this event during their week-12 visit. Subject was treated with pain medication.