Table 4. Incidence of Adverse Events by Ofatumumab Treatment Course in OFA110634.
| Ofatumumab Treatment Course | ||||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | Overall | |
| OFA110634 | N = 148 | N = 93 | N = 63 | N = 30 | N = 13 | N = 6 | N = 0 | N = 148 |
| Any AE | 127 (86) | 60 (65) | 37 (59) | 17 (57) | 8 (62) | 5 (83) | - | 134 (91) |
| IRR on day of first infusion | 101 (68) | 48 (52) | 18 (29) | 10 (33) | 2 (15) | 1 (17) | - | 110 (74) |
| IRR on day of second infusion | 1 (<1) | 2 (2) | 0 | 3 (10) | 0 | 0 | - | 6 (4) |
| AE leading to discontinuation of investigational product/withdrawal | 21 (14) | 1 (1) | 1 (2) | 0 | 1 (8) | 0 | - | 24 (16) |
| Any SAE (fatal or non-fatal) | 20 (14) | 10 (11) | 2 (3) | 1 (3) | 0 | 0 | - | 30 (20) |
| Serious IRR | 8 (5) | 1 (1) | 0 | 0 | 0 | 0 | 0 | 8 (5) |
| SAE leading to discontinuation of investigational product/withdrawal | 8 (5) | 0 | 1 (1) | 0 | 0 | 0 | - | 9 (6) |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | - | 0 |
| Any infection | 30 (20) | 20 (22) | 12 (19) | 4 (13) | 3 (23) | 3 (50) | - | 48 (32) |
| Most common infections (≥5% overall) | ||||||||
| Gastroenteritis | 4 (3) | 3 (3) | 1 (1) | 0 | 1 (8) | 0 | - | 9 (6) |
| Urinary tract infection | 4 (3) | 4 (4) | 2 (3) | 0 | 0 | 0 | - | 9 (6) |
| Bronchitis | 3 (2) | 1 (1) | 0 | 3 (10) | 0 | 0 | - | 7 (5) |
| Nasopharyngitis | 6 (4) | 2 (2) | 1 (1) | 0 | 0 | 0 | - | 7 (5) |
| Any serious infection | 2 (1) | 5 (5) | 0 | 0 | 0 | 0 | - | 7 (5) |
| Urinary tract infection | 1 (<1) | 1 (1) | 0 | 0 | 0 | 0 | - | 2 (1) |
| Cellulitis | 0 | 1 (1) | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Gastroenteritis | 0 | 1 (1) | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Herpes oesophagitis | 0 | 1 (1) | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Oesophageal candidiasis | 0 | 1 (1) | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Oral candidiasis | 1 (<1) | 0 | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Respiratory tract infection | 0 | 1 (1) | 0 | 0 | 0 | 0 | - | 1 (<1) |
| Any neoplasm | 3 (2) | 1 (1) | 0 | 0 | 0 | 0 | - | 3 (2) |
| Any serious malignant neoplasm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE, adverse event; IRR, infusion-related reaction; SAE, serious adverse event. Incidences are expressed as number (%) of patients with each type of event. Percentages are based on the number of patients who received at least one infusion of ofatumumab for the respective treatment course. Ofatumumab treatment course is the course that the patient was receiving at the onset of the event. Infections were those events reported in the MedDRA System Organ Class of “Infections and infestations”. Neoplasms were those events reported in the MedDRA System Organ Class of “Neoplasms (benign, malignant and unspecified, including cysts and polyps)”.