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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
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