Table 2 Adverse events observed in all patients who received the GMA therapy (n = 437)

Common disorders and administration site conditions

Fever

6

(1.4)

0

2

(0.5)

Chill

1

(0.2)

0

0

Gastrointestinal disorder

Nausea/Vomiting

9

(2.1)

0

2

(0.5)

Abdominal discomfort

3

(0.7)

0

2

(0.5)

Nervous system disorder

Headache

10

(2.3)

0

6

(1.4)

Peripheral neuropathy

2

(0.5)

0

2

(0.5)

Laboratory test value abnormality

Abnormal liver function test

4

(0.9)

0

1

(0.2)

Mental disorder

Dysphoria

4

(0.9)

0

0

Panic disorder

1

(0.2)

0

0

Infectious disease and parasitic disease

Sepsis

3

(0.7)

3

(0.7)

0

Pyelonephritis

1

(0.2)

1

(0.2)

0

Common cold

2

(0.5)

0

0

Catheter-related infection

1

(0.2)

0

0

Blood and lymphatic system disorder

Disseminated intravascular coagulation

3

(0.7)

3

(0.7)

0

Febrile neutropenia

1

(0.2)

1

(0.2)

0

Pancytopenia

1

(0.2)

1

(0.2)

0

Respiratory, thorax, and mediastinal disorder

Aspiration pneumonitis

1

(0.2)

1

(0.2)

0

Oropharyngeal discomfort

1

(0.2)

0

0

Hypoxia

1

(0.2)

0

0

Musculoskeletal system and connective tissue disorder

Back pain

1

(0.2)

0

1

(0.2)

Low back pain

1

(0.2)

0

0

Coxitis

1

(0.2)

0

0

Vascular disorder

Hypotension

3

(0.7)

2

(0.5)

0

Thromboembolic event

1

(0.2)

1

(0.2)

0

Aortitis syndrome (Takayasu’s arteritis)

1

(0.2)

1

(0.2)

0

Cardiac disorder

Palpitation

1

(0.2)

0

0

Atrial fibrillation

1

(0.2)

1

(0.2)

0

Immune system disorder

Drug hypersensitivity

3

(0.7)

0

0

Hepatobiliary disorder

Bile duct stone

1

(0.2)

1

(0.2)

0