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Table 2 Treatment-Emergent Adverse Events with Severity Grade 3 or 4 for Patients with CR Following First- or Second-Line Therapy (Safety Population)

From: Progression-free and overall survival in ovarian cancer patients treated with CVac, a mucin 1 dendritic cell therapy in a randomized phase 2 trial

 

NR-CVac

CVac

SOC

Total

(N = 7)

(N = 26)

(N = 24)

(N = 57)

Patients with TEAE of Severity 3 or 4

0 (0 %)

7 (27 %)

2 (8 %)

9 (16 %)

Small intestinal obstruction

0 (0 %)

2 (8 %)

0 (0 %)

2 (4 %)

Abdominal pain

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Alanine aminotransferase increased

0 (0 %)

0 (0 %)

1 (4 %)

1 (2 %)

Arthralgia

0 (0 %)

0 (0 %)

1 (4 %)

1 (2 %)

Bunion

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Cough

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Diarrhea

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Disease Progression

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Escherichia urinary tract infection

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Febrile neutropenia

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Gamma-glutamyltransferase increased

0 (0 %)

0 (0 %)

1 (4 %)

1 (2 %)

Hand fracture

0 (0 %)

0 (0 %)

1 (4 %)

1 (2 %)

Headache

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Meniscus lesion

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Metastases to liver

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Ovarian epithelial cancer metastatic

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Pruritus generalized

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)

Sinusitis

0 (0 %)

1 (4 %)

0 (0 %)

1 (2 %)