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. Author manuscript; available in PMC: 2021 Oct 25.
Published in final edited form as: Cancer Discov. 2021 Mar 11;11(8):1996–2013. doi: 10.1158/2159-8290.CD-20-1546

Table 1.

Adverse events to tilsotolimod + ipilimumab (N = 62)

Characteristic Patients, n (%)
Patients with at least one TEAE 61 (98.4)
Patients with at least one grade 3/4 TEAE 30 (48.4)
Patients with at least one SAE 20 (32.3)
Patients with at least one immune-related TEAE 16 (25.8)
Patients discontinuing tilsotolimod due to TEAEs 3 (4.8)
Patients discontinuing ipilimumab due to TEAEs 6 (9.7)
Patients discontinuing tilsotolimod due to immune-related TEAEs 4 (6.5)
Patients discontinuing ipilimumab due to immune-related TEAEs 3 (4.8)
Most common TEAEsa
 Fatigue 32 (51.6)
 Nausea 25 (40.3)
 Anemia 24 (38.7)
 Diarrhea 23 (37.1)
 Pyrexia 22 (35.5)
 ALT increased 20 (32.3)
 Vomiting 19 (30.6)
 Headache 18 (29.0)
 Rash 17 (27.4)
 AST increased 16 (25.8)
 Chills 16 (25.8)
Most common grade 3/4 TEAEsb
 Diarrhea 4 (6.5)
 ALT increased 4 (6.5)
 AST increased 4 (6.5)
 Colitisc 4 (6.5)
 Fatigue 3 (4.8)
Most common immune-related TEAEsd
 Hypophysitis 5 (8.1)
 Rash 5 (8.1)
 Colitisc 4 (6.5)
 ALT increased 4 (6.5)
 AST increased 4 (6.5)
 Diarrhea 4 (6.5)
 Hepatitise 3 (4.8)
Most common grade 3/4 immune-related TEAEsd
 Colitisc 3 (4.8)
 ALT increased 3 (4.8)
 AST increased 3 (4.8)
 Hepatitise 2 (3.2)
 Hypophysitis 2 (3.2)
 Diarrhea 2 (3.2)

Abbreviation: SAE, severe adverse effect.

a

TEAEs that occurred in ≥25% of patients are shown and are listed in order of decreasing frequency.

b

Grade 3 or 4 TEAEs that occurred in ≥3 patients are shown and are listed in order of decreasing frequency.

c

Includes preferred terms of colitis, autoimmune colitis, and enterocolitis.

d

Includes events that occurred in ≥3. Immune-related AEs were identified during a sponsor review following database lock that was confirmed with the investigators.

e

Includes patients with immune-related hepatitis or autoimmune hepatitis.