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Table 4 Comparison of AEs risk between T-VEC alone and in combination with ICIs

From: Safety of talimogene laherparepvec: a real‐world retrospective pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS)

Immune checkpoint inhibitors

Preferred term

N

ROR (95%CI)

Pembrolizumab

MALIGNANT MELANOMA

9

2.83 (1.32-6.05)

MALIGNANT NEOPLASM PROGRESSION

6

5.95 (2.15-16.42)

RASH

6

3.24 (1.27-8.26)

DYSPNOEA

5

5.40 (1.81-16.11)

IMMUNE-MEDIATED ADVERSE REACTION

4

43.14 (4.78-389.59)

AUTOIMMUNE COLITIS

4

21.55 (3.90-119.08)

PLATELET COUNT DECREASED

4

8.60 (2.27-32.51)

HYPOTENSION

4

4.28 (1.32-13.88)

Ipilimumab

DRUG INEFFECTIVE

6

12.03 (4.51-32.12)

MALIGNANT NEOPLASM PROGRESSION

4

13.25 (4.06-43.3)

MALIGNANT MELANOMA

4

4.21 (1.41-12.59)

DEATH

4

3.02 (1.02-8.93)

Atezolizumab

CYTOKINE RELEASE SYNDROME

4

56.10 (13.14-239.51)

Nivolumab

OFF LABEL USE

13

2.16 (1.12-4.15)

DRUG INEFFECTIVE

8

10.30 (4.31-24.61)

DEHYDRATION

4

20.03 (5.21-77.08)

SEPSIS

4

11.09 (3.29-37.35)

  1. ROR reporting odds ratio, CI confidence interval