Table 2.
Summary of AEs and selected treatment-related AEs of special interest occurring in ≥2% of patients (any Grade) or in any patients (Grade 3 or higher) − combined cohorts
| n (%) | D10–20 q4/2w T1* n=56 |
D10–20 q4/2w T3 n=34 |
D15 q4w T10 n=9 |
All cohorts N=102 |
||||
|---|---|---|---|---|---|---|---|---|
|
Summary of AEs
| ||||||||
| Any AE | 55 (98) | 34 (100) | 9 (100) | 101 (99) | ||||
| Any Grade 3/4 AE | 35 (63) | 29 (85) | 8 (89) | 72 (71) | ||||
| Any death | 15 (27) | 6 (18) | 1 (11) | 22 (22) | ||||
| SAE | 31 (55) | 26 (76) | 8 (89) | 66 (65) | ||||
| AE leading to discontinuation | 16 (29) | 18 (53) | 5 (56) | 40 (39) | ||||
| Related AE | 41 (73) | 32 (94) | 8 (89) | 82 (80) | ||||
| Related Grade 3/4 AE | 17 (30) | 19 (56) | 7 (78) | 43 (42) | ||||
| Related death | 2 (4) | 1 (3) | 0 (0) | 3 (3) | ||||
| Related SAE | 12 (21) | 18 (53) | 7 (78) | 37 (36) | ||||
| Related AE leading to discontinuation | 9 (16) | 15 (44) | 5 (56) | 29 (28) | ||||
|
Selected treatment-related AEs of interest | ||||||||
| Clinical conditions | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 |
|
| ||||||||
| Diarrhoea | 13 (23) | 4 (7) | 16 (47) | 6 (18) | 4 (44) | 1 (11) | 33 (32) | 11 (11) |
| Colitis | 2 (4) | 1 (2) | 8 (24) | 6 (18) | 2 (22) | 2 (22) | 12 (12) | 9 (9) |
| Enteritis | 1 (2) | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1) | 1 (1) |
| Pruritus | 11 (20) | 0 (0) | 7 (21) | 0 (0) | 3 (33) | 0 (0) | 21 (21) | 0 (0) |
| Rash | 6 (11) | 0 (0) | 7 (21) | 0 (0) | 2 (22) | 0 (0) | 15 (15) | 0 (0) |
| Hypothyroidism | 5 (9) | 1(2) | 4 (12) | 0 (0) | 1 (11) | 0 (0) | 10 (10) | 1 (1) |
| Pneumonitis | 0 (0) | 0 (0) | 3 (9) | 2 (6) | 2 (22) | 2 (22) | 5 (5) | 4 (4) |
| Rash maculopapular | 1 (2) | 0 (0) | 2 (6) | 0 (0) | 1 (11) | 1 (11) | 4 (4) | 1 (1) |
|
| ||||||||
| Investigations | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 |
|
| ||||||||
| Amylase increased† | 9 (16) | 1 (2) | 5 (15) | 2 (6) | 2 (22) | 0 (0) | 17 (17) | 3 (3) |
| Lipase increased† | 7 (13) | 5 (9) | 4 (12) | 2 (6) | 1 (11) | 1 (11) | 12 (12) | 8 (8) |
| ALT increased | 6 (11) | 2 (4) | 4 (12) | 1 (3) | 0 (0) | 0 (0) | 10 (10) | 3 (3) |
| AST increased | 4 (7) | 3 (5) | 3 (9) | 1 (3) | 0 (0) | 0 (0) | 7 (7) | 4 (4) |
| Blood TSH decreased | 2 (4) | 0 (0) | 2 (6) | 0 (0) | 2 (22) | 0 (0) | 6 (6) | 0 (0) |
| Blood creatinine increased | 1 (2) | 0 (0) | 2 (6) | 0 (0) | 1 (11) | 0 (0) | 4 (4) | 0 (0) |
| Blood TSH increased | 3 (5) | 0 (0) | 1 (3) | 0 (0) | 1 (11) | 0 (0) | 5 (5) | 0 (0) |
| Thyroxine free decreased | 2 (4) | 0 (0) | 2 (6) | 0 (0) | 0 (0) | 0 (0) | 4 (4) | 0 (0) |
Note: A patient may be counted in multiple preferred terms
*
Excludes D3 q4w T1 cohort (n=3)
†
Amylase/lipase increase was added to AEs of significant interest list because it matched the dose-limiting toxicity criteria.
AE=adverse event; ALT=alanine transaminase; AST=aspartate transaminase; D=durvalumab; GGT=gamma-glutamyl transferase; q=every; SAE=serious AE; T=tremelimumab; TSH=thyroid-stimulating hormone; w=weeks.