Table 3 Incidence of related adverse events by system organ class preferred term and NCI-CTCAE grade, safety population. No grade 4 or 5 adverse events observed in part 2.

From: BETA prime: a first-in-man phase 1 study of AdAPT-001, an armed oncolytic adenovirus for solid tumors

System organ class

Preferred term

Treatment

Grade 1

Grade 2

Grade 3

Total (n = 19)

Cardiac disorders

Tachycardia

AdAPT-001 1 × 1012 VP

0 (0.0)

1 (5.3)

0 (0.0)

1 (5.3)

Gastrointestinal disorders

Dry mouth

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

 

Nausea

AdAPT-001 1 × 1012 VP

0 (0.0)

1 (5.3)

0 (0.0)

1 (5.3)

 

Vomiting

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

General disorders and administration site conditions

Asthenia

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

 

Chills

AdAPT-001 1 × 1012 VP

5 (26.3)

1 (5.3)

0 (0.0)

6 (31.6)

 

Fatigue

AdAPT-001 1 × 1012 VP

1 (5.3)

1 (5.3)

0 (0.0)

2 (10.5)

 

Injection related reaction

AdAPT-001 1 × 1012 VP

5 (26.3)

0 (0.0)

0 (0.0)

5 (26.3)

 

Pyrexia

AdAPT-001 1 × 1012 VP

2 (10.5)

1 (5.3)

0 (0.0)

3 (15.8)

 

Swelling face

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

Infections and infestations

Sinusitis

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

Injury, poisoning, and procedural complications

Injection related reaction

AdAPT-001 1 × 1012 VP

2 (10.5)

1 (5.3)

0 (0.0)

3 (15.8)

Investigations

Platelet count decreased

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

Musculoskeletal and connective tissue disorders

Arthralgia

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

 

Neck pain

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

 

Pain in extremity

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

Nervous system disorders

Dysgeusia

AdAPT-001 1 × 1012 VP

1 (5.3)

0 (0.0)

0 (0.0)

1 (5.3)

Skin and subcutaneous tissues disorders

Dermatitis acneiform

AdAPT-001 1 × 1012 VP

0 (0.0)

0 (0.0)

1 (5.3)

1 (5.3)

Vascular disorders

Hypertension

AdAPT-001 1 × 1012 VP

0 (0.0)

0 (0.0)

1 (5.3)

1 (5.3)