Table 3 Summary of AEs and adverse reactions (safety set)

From: Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial

 

Siltartoxatug 10 mg

HTIG 250 IU

Total

(N = 440)

(N = 221)

(N = 661)

n (%)

n (%)

n (%)

Any AE

168 (38.2)

75 (33.9)

243 (36.8)

 Mild

127 (28.9)

54 (24.4)

181 (27.4)

 Moderate

69 (15.7)

29 (13.1)

98 (14.8)

 Severe

5 (1.1)

2 (0.9)

7 (1.1)

Serious AE

6 (1.4)

2 (0.9)

8 (1.2)

AEs leading to study discontinuation

0

0

0

Death

0

1 (0.5)

1 (0.2)

Treatment-related AE

21 (4.8)

8 (3.6)

29 (4.4)

 Investigation

9 (2.0)

2 (0.9)

11 (1.7)

  Transaminases increased

3 (0.7)

0

3 (0.5)

  Urinary occult blood positive

2 (0.5)

1 (0.5)

3 (0.5)

  Blood glucose increased

2 (0.5)

0

2 (0.3)

  Glucose urine present

2 (0.5)

0

2 (0.3)

  Aspartate aminotransferase increased

1 (0.2)

1 (0.5)

2 (0.3)

  Blood bilirubin increased

1 (0.2)

0

1 (0.2)

  Electrocardiogram Q wave abnormal

1 (0.2)

0

1 (0.2)

  Gamma-glutamyltransferase increased

1 (0.2)

0

1 (0.2)

  Alanine aminotransferase increased

0

1 (0.5)

1 (0.2

 Renal and urinary disorders

3 (0.7)

1 (0.5)

4 (0.6)

  Hematuria

3 (0.7)

1 (0.5)

4 (0.6)

 General disorders and administration site conditions

2 (0.5)

1 (0.5)

3 (0.5)

  Injection site erythema

1 (0.2)

0

1 (0.2)

  Injection site hypoesthesia

1 (0.2)

0

1 (0.2)

  Injection site pain

1 (0.2)

0

1 (0.2)

  Injection site swelling

0

1 (0.5)

1 (0.2)

 Nervous system disorders

2 (0.5)

1 (0.5)

3 (0.5)

  Dizziness

1 (0.2)

1 (0.5)

2 (0.3)

  Head discomfort

1 (0.2)

0

1 (0.2)

 Blood and lymphatic system disorders

2 (0.5)

0

2 (0.3)

  Anemia

1 (0.2)

0

1 (0.2)

  Coagulopathy

1 (0.2)

0

1 (0.2)

 Cardiac disorders

2 (0.5)

0

2 (0.3)

  Arteriospasm coronary

1 (0.2)

0

1 (0.2)

  Ventricular extrasystoles

1 (0.2)

0

1 (0.2)

 Musculoskeletal and connective tissue disorders

1 (0.2)

2 (0.9)

3 (0.5)

  Arthralgia

1 (0.2)

0

1 (0.2)

  Muscular weakness

0

1 (0.5)

1 (0.2)

  Myalgia

0

1 (0.5)

1 (0.2)

 Skin and subcutaneous tissue disorders

1 (0.2)

2 (0.9)

3 (0.5)

  Allergic dermatitis

1 (0.2)

1 (0.5)

2 (0.3)

  Urticaria

0

1 (0.5)

1 (0.2)

 Hepatobiliary disorders

1 (0.2)

0

1 (0.2)

  Abnormal hepatic function

1 (0.2)

0

1 (0.2)

 Metabolism and nutrition disorders

1 (0.2)

0

1 (0.2)

  Hyperuricemia

1 (0.2)

0

1 (0.2)

  1. AEs were coded according to the System Organ Class and Preferred Term of the Medical Dictionary for Regulatory Activities terminology v.26.0.
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