Table 3 Summary of study treatment-related adverse eventsa (safety cohort [N = 46])

From: A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma

Treatment-related adverse events (TRAE)

Arm A Cy-GVAX n = 17

Arm B Cy-GVAX PD-1 n = 18

Arm C Cy-GVAX PD-1 CD137 n = 11

TRAE, #pts (any grade)

Abdominal pain

0 (0%)

0 (0%)

3 (27.3%)

AST/ALT elevation

0 (0%)

0 (0%)

1 (9.1%)

Chills/sweats

4 (23.5%)

2 (11.1%)

2 (18.2%)

Dermatitisb

3 (17.6%)

3 (16.7%)

6 (54.5%)

Diarrhea

0 (0%)

1 (5.6%)

1 (9.1%)

Colitis

0 (0%)

1 (5.6%)

0 (0%)

Dizziness/presyncope

1 (5.9%)

1 (5.6%)

0 (0%)

Fatigue

5 (29.4%)

8 (44.4%)

6 (54.5%)

Fever

3 (17.6%)

4 (22.2%)

2 (18.2%)

Headache

2 (11.8%)

2 (11.1%)

0 (0%)

Malaise

1 (5.9%)

5 (27.8%)

1 (9.1%)

Myalgia/arthralgia

1 (5.9%)

6 (33.3%)

2 (18.2%)

Nausea

2 (11.8%)

3 (16.7%)

8 (72.7%)

Other

0 (0%)

0 (0%)

2 (18.2%)

Swelling

0 (0%)

1 (5.6%)

1 (9.1%)

Thyroid disorder

0 (0%)

0 (0%)

4 (36.4%)

Vomiting

2 (11.8%)

2 (11.1%)

2 (18.2%)

Grade ≥3 TRAEc

0 (0%)

1 (5.6%)

1 (9.1%)

Serious TRAE (SAE)d

0 (0%)

1 (5.6%)

0 (0%)

Trial therapy dose delay due to TRAE

0 (0%)

0 (0%)

1 (9.1%)

Off trial due to TRAE

0 (0%)

0 (0%)

0 (0%)

  1. aDoes not include vaccine site reactions (VSR). Common VSRs included erythema, swelling, tenderness, and itching at vaccine sites.
  2. bIncludes hives, pruritus, rash.
  3. cGrade 3+ TRAEs included grade 3 colitis (Arm B) and grade 3 rash (Arm C).
  4. dSAE (treatment-related) was grade 3 colitis.
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