Table 4.
Most commonly reported treatment-emergent AEs, by race and treatment group (safety population)
| Race |
||||||||
|---|---|---|---|---|---|---|---|---|
| Asian |
White |
Other |
Black |
|||||
| Patients who experienced at least one AE | MMF (n = 62) | IVC (n = 60) | MMF (n = 74) | IVC (n = 71) | MMF (n = 22) | IVC (n = 31) | MMF (n = 26) | IVC (n = 18) |
| All AEs | 59 (95.2) | 54 (90.0) | 72 (97.3) | 69 (97.2) | 46 (95.8) | 48 (98.0) | 25 (96.2) | 18 (100) |
| Diarrhoea | 10 (16.1) | 6 (10) | 27 (36.5) | 9 (12.7) | 6 (27.3) | 5 (16.1) | 9 (34.6) | 3 (16.7) |
| Nausea and vomiting | 13 (21.0) | 32 (53.3) | 20 (27.0) | 40 (56.3) | 3 (13.6) | 17 (54.8) | 6 (23.1) | 9 (50.0) |
| Headache | 6 (9.7) | 3 (5.0) | 18 (24.3) | 24 (33.8) | 1 (4.5) | 14 (45.2) | 6 (23.1) | 9 (50.0) |
| Joint-related signs and symptoms (arthralgia) | 6 (9.7) | 8 (13.3) | 18 (24.3) | 24 (33.8) | 0 (0) | 8 (25.8) | 7 (26.9) | 3 (16.7) |
| Gastrointestinal and abdominal pain | 5 (8.1) | 4 (6.7) | 19 (25.7) | 11 (15.5) | 4 (18.2) | 9 (29.0) | 6 (23.1) | 6 (33.3) |
| Musculoskeletal and connective tissue signs and symptoms (back pain) | 4 (6.5) | 3 (5.0) | 15 (20.3) | 14 (19.7) | 4 (18.2) | 6 (19.4) | 8 (30.8) | 5 (27.8) |
| Oedema | 13 (21.0) | 12 (20.0) | 18 (24.3) | 22 (31.0) | 4 (18.2) | 10 (32.3) | 7 (26.9) | 7 (38.9) |
| Upper respiratory tract infections | 23 (37.1) | 24 (40) | 3 (4.1) | 10 (14.1) | 6 (27.3) | 10 (32.3) | 6 (23.1) | 7 (38.9) |
| Alopecia | 7 (11.3) | 17 (28.3) | 10 (13.5) | 31 (43.7) | 4 (18.2) | 9 (29.0) | 2 (7.7) | 4 (22.2) |
| Coughing | 12 (19.4) | 4 (6.7) | 10 (13.5) | 10 (14.1) | 4 (18.2) | 6 (19.4) | 6 (23.1) | 6 (33.3) |
| Hypertension | 6 (9.7) | 1 (1.7) | 11 (14.9) | 12 (16.9) | 5 (22.7) | 9 (29.0) | 4 (15.4) | 3 (16.7) |
| Anaemia | 19 (16.1) | 0 (0) | 6 (8.1) | 4 (5.6) | 3 (13.6) | 8 (25.8) | 4 (15.4) | 1 (5.6) |
| Rashes, eruptions and exanthema | 6 (9.7) | 5 (8.3) | 8 (10.8) | 12 (16.9) | 0 (0) | 3 (9.7) | 5 (19.2) | 6 (33.3) |
| Asthenic conditions (fatigue) | 7 (11.3) | 4 (6.7) | 13 (17.6) | 18 (25.4) | 0 (0) | 4 (12.9) | 6 (23.1) | 5 (27.8) |
| Febrile disorders | 5 (8.1) | 15 (25.0) | 7 (9.5) | 12 (16.9) | 0 (0) | 2 (6.5) | 0 (0) | 1 (5.6) |
| Muscle-related signs and symptoms (muscle spasm) | 3 (4.8) | 1 (1.7) | 9 (12.2) | 10 (14.1) | 1 (4.5) | 5 (16.1) | 6 (23.1) | 3 (16.7) |
| Urinary tract infections | 0 (0) | 0 (0) | 10 (13.5) | 7 (9.9) | 2 (9.1) | 5 (16.1) | 4 (15.4) | 2 (11.1) |
| Leucopenias | 5 (8.1) | 8 (13.3) | 2 (2.7) | 17 (23.9) | 4 (18.2) | 12 (38.7) | 1 (3.8) | 5 (27.8) |
| Potassium imbalance (hypokalaemia) | 0 (0) | 0 (0) | 2 (2.7) | 2 (2.8) | 2 (9.1) | 3 (9.7) | 6 (23.1) | 1 (5.6) |
| Menstruation with decreased bleeding (amenorrhoea) | 0 (0) | 1 (1.7) | 0 (0) | 2 (2.8) | 0 (0) | 5 (16.1) | 1 (3.8) | 2 (11.1) |
| All SAEs | 21 (33.9) | 17 (28.3) | 18 (24.3) | 16 (22.5) | 5 (22.7) | 5 (16.1) | 7 (26.9) | 3 (16.7) |
| All infections | 39 (62.9) | 29 (48.3) | 54 (73.0) | 54 (76.1) | 33 (68.8) | 28 (57.1) | 21 (80.8) | 10 (55.6) |
Values are given as n (%).