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Table 3 ADR manifestations of XSTI

From: Post-marketing safety surveillance and re-evaluation of Xueshuantong injection

Systems/organs

Number of cases/incidence rate ‰

Constituent ratio (%)

Manifestations (number of cases/frequency‰)

Skin and its appendages

125/4.05

52.97

erythra (61/1.98), pruritus (50/1.62), maculopapule (8/0.26), hyperhidrosis (4/0.13), urticaria (4/0.13)

Systemic injury

22/0.71

9.32

fever (6/0.19), Shiver (6/0.19), edema (4/0.13), Chest pain (2/0.06), anaphylactoid reaction (1/0.03), periorbital edema (1/0.03), hot flush (1/0.03), acratia (1/0.03)

Central and peripheral nervous system damage

21/0.68

8.90

headache (9/0.29), giddy (6/0.19), paresthesia (4/0.13), lower limb spasticity (1/0.03), tremor (1/0.03)

Gastrointestinal system damage

14/0.45

5.93

sicchasia (4/0.13), vomit (2/0.06), hemorrhage of gastrointestinal tract (1/0.03), aggravation of gastrointestinal bleeding (1/0.03), dry lips (1/0.03), Stool discoloration (1/0.03), abdominal pain (1/0.03), discoloration of tongue (1/0.03), flatulence (1/0.03), toothache (1/0.03)

Respiratory system damage

14/0.45

5.93

Chest tightness (10), dyspnea (2), laryngeal spasm (1/0.03), epistaxis (1/0.03)

Extra cardiac vessel damage

10/0.32

4.24

flushing (9/0.29), phlebitis (1/0.03)

Medication site damage

10/0.32

4.24

local numbness (4/0.13), injection site pain (4/0.13), injection site numbness (1/0.03), injection site pruritus (1/0.03)

Urinary system damage

7/0.23

2.97

facial edema (6/0.19), hematuria (1/0.03)

Heart rate and arrhythmia

6/0.19

2.54

palpitation (5/0.16), tachycardia (1/0.03)

Nerve disorders

4/0.13

1.69

feel suffocated (3/0.10), insomnia (1/0.03)

Visual impairment

1/0.03

0.42

abnormal tears (1/0.03)

General cardiovascular system damage

1/0.03

0.42

Hypertension (1/0.03)

latelets and bleeding, coagulopathy

1/0.03

0.42

Gingival bleeding (1/0.03)

Total

236

100.00

 
  1. Incidence rate = number of adverse events *1000‰/ total number of cases