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Table 1 Characteristics of patients and adverse event reports among andrographis products users

From: Characterization of hypersensitivity reactions reported among Andrographis paniculata users in Thailand using Health Product Vigilance Center (HPVC) database

Characteristics No. (%) [n = 106]a
Patients  
Sex  
 Female 76 (71.7)
 Male 30 (28.3)
Age [y], mean (SD) [min – max] 38.5 (18.4) [8 – 80]
 <15 11 (10.4)
 15-30 26 (24.5)
 31-60 49 (46.2)
 >60 11 (10.4)
 N/A 9 (8.5)
History of drug allergy  
 No 93 (87.7)
 Yes 12 (11.3)
 N/A 1 (1.0)
Adverse event reports  
Source of reports  
 Spontaneous 95 (89.6)
 Intensive 11 (10.4)
Seriousness  
 Serious 18 (17.0)
  Hospitalization or prolongation of hospitalization 16
  Life threatening 2
 Non-serious 88 (83.0)
Causality assessmentb  
 Certain 8 (7.5)
 Probable 61 (57.6)
 Possible 33 (31.1)
 Unlikely 0 (0.0)
 N/A 4 (3.8)
No. of concomitant drug, mean (SD) [min – max] 0.4 (0.8) [0 – 4]
 None 82 (77.4)
 1item 13 (12.3)
 2items 7 (6.6)
 3items 3 (2.8)
 ≥4items 1 (0.9)
Time of exposure (day), mean (SD) [min – max] 1.2 (3.4) [0 – 30]
 1 day 51 (48.1)
 2 days 20 (18.9)
 3 days 14 (13.2)
 ≥4 days 8 (7.6)
 N/Ac 13 (12.2)
Time to onset (day), mean (SD) [min – max] 0.8 (1.6) [0 – 8]
 First day of use 61 (57.6)
 2daysof use 24 (22.6)
 3 days of use 15 (14.2)
 ≥4 days of use 5 (4.7)
 N/A 1 (0.9)
  1. aAll 106 reports contained hypersensitivity reactions and an andrographis product was considered as the sole suspected drug.
  2. bAs per reported from health professional.
  3. cSome reports had no information on starting date, stopping date, or both.
  4. N/A = not available.
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