Table 3.
Summary of TEAEs.
| TEAE | Arm 1 (n = 60) | Arm 2 (n = 20) | Total (n = 80) | |||
|---|---|---|---|---|---|---|
| Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | |
| Any TEAE, n (%) | 60 (100) | 37 (62) | 20 (100) | 14 (70) | 80 (100) | 51 (64) |
| TEAEs in ≥ 20% of patients in any arm, n (%) | ||||||
| Fatigue | 41 (68) | 7 (12) | 15 (75) | 1 (5) | 56 (70) | 8 (10) |
| Diarrhoea | 34 (57) | 1 (2) | 12 (60) | 4 (20) | 46 (58) | 5 (6) |
| Nausea | 29 (48) | 1 (2) | 10 (50) | 0 | 39 (49) | 1 (1) |
| Myalgia | 20 (33) | 3 (5) | 9 (45) | 2 (10) | 29 (36) | 5 (6) |
| Cough | 20 (33) | 0 | 6 (30) | 1 (5) | 26 (33) | 1 (1) |
| Maculopapular rash | 18 (30) | 3 (5) | 8 (40) | 2 (10) | 26 (33) | 5 (6) |
| Headache | 19 (32) | 0 | 5 (25) | 1 (5) | 24 (30) | 1 (1) |
| Arthralgia | 20 (33) | 2 (3) | 3 (15) | 2 (10) | 23 (29) | 4 (5) |
| Constipation | 16 (27) | 1 (2) | 6 (30) | 0 | 22 (28) | 1 (1) |
| Dizziness | 13 (22) | 0 | 9 (45) | 1 (5) | 22 (28) | 1 (1) |
| Vomiting | 16 (27) | 1 (2) | 6 (30) | 0 | 22 (28) | 1 (1) |
| Muscle spasms | 16 (27) | 0 | 5 (25) | 1 (5) | 21 (26) | 1 (1) |
| Pyrexia | 16 (27) | 2 (3) | 5 (25) | 3 (15) | 21 (26) | 5 (6) |
| Stomatitis | 10 (17) | 1 (2) | 11 (55) | 0 | 21 (26) | 1 (1) |
| Upper respiratory infection | 13 (22) | 0 | 7 (35) | 0 | 20 (25) | 0 |
| Dry eye | 15 (25) | 0 | 4 (20) | 0 | 19 (24) | 0 |
| Urinary tract infection | 13 (22) | 1 (2) | 5 (25) | 2 (10) | 18 (23) | 3 (4) |
| Paraesthesia | 9 (15) | 1 (2) | 8 (40) | 1 (5) | 17 (21) | 2 (3) |
| Abdominal pain | 12 (20) | 1 (2) | 4 (20) | 0 | 16 (20) | 1 (1) |
| Dyspnoea | 12 (20) | 1 (2) | 4 (20) | 0 | 16 (20) | 1 (1) |
| Infusion‐related reaction | 14 (23) | 0 | 1 (5) | 0 | 15 (19) | 0 |
| Oropharyngeal pain | 10 (17) | 0 | 5 (25) | 0 | 15 (19) | 0 |
| Vision blurred | 8 (13) | 0 | 6 (30) | 0 | 14 (18) | 0 |
| Memory impairment | 9 (15) | 0 | 5 (25) | 0 | 14 (18) | 0 |
| Sinusitis | 7 (12) | 0 | 5 (25) | 0 | 12 (15) | 0 |
| Hypomagnesaemia | 6 (10) | 0 | 4 (20) | 0 | 10 (13) | 0 |
| Lacrimation increased | 3 (5) | 0 | 6 (30) | 0 | 9 (11) | 0 |
| Peripheral swelling | 5 (8) | 0 | 4 (20) | 0 | 9 (11) | 0 |
| Dry mouth | 4 (7) | 0 | 4 (20) | 0 | 8 (10) | 0 |
| Any serious TEAE, n (%) | 14 (23) | 11 (18) | 6 (30) | 5 (25) | 20 (25) | 16 (20) |
| Any Grade 5 TEAE, n (%) | 2 (3) | 2 (3) | 0 | 0 | 2 (3) | 2 (3) |
| Dose modifications due to a TEAE, n (%) | ||||||
| Ibrutinib dose reduction | 9 (15) | 6 (10) | 5 (25) | 4 (20) | 14 (18) | 10 (13) |
| Withholding of rituximab dose | 1 (2) | 1 (2) | 1 (5) | 1 (5) | 2 (3) | 2 (3) |
| Discontinuation due to a TEAE, n (%) | ||||||
| Discontinuation of ibrutinib | 14 (23) | 11 (18) | 2 (10) | 1 (5) | 16 (20) | 12 (15) |
| Discontinuation of rituximab | 0 | 0 | 0 | 0 | 0 | 0 |
TEAE, treatment‐emergent adverse event.