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Table 4 Patient-reported Adverse events

From: Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

Characteristic Liquid Kaloba® (n = 42) Liquid Placebo (n = 40) Tablet Kaloba® (n = 26) Tablet Placebo (n = 26) Total (n = 134)
Number of patients that experienced at least one Side-effect – n (%)1 7 (16.7%) 3 (7.5%) 2 (8.0%) 2 (7.7%) 14 (10.5%)
Total number of Side-effects – n2 28 (68.3%) 8 (19.5%) 3 (7.3%) 2 (4.9%) 41 (100.0%)
Summary of Side-effects – n (%)2
 Frequent bouts of Vomiting3 1 (3.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (2.4%)
 Bad taste in mouth 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (50.0%) 1 (2.4%)
 Burping 0 (0.0%) 3 (37.5%) 0 (0.0%) 0 (0.0%) 3 (7.3%)
 Cough 4 (14.3%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 4 (9.8%)
 Diarrhoea 1 (3.6%) 0 (0.0%) 1 (33.3%) 0 (0.0%) 2 (4.9%)
 Disturbed Sleep 1 (3.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (2.4%)
 Drowsiness 1 (3.6%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (2.4%)
 Feeling Bloated 0 (0.0%) 3 (37.5%) 0 (0.0%) 0 (0.0%) 3 (7.3%)
 Feeling Unwell 3 (10.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 3 (7.3%)
 Headaches 3 (10.7%) 1 (12.5%) 0 (0.0%) 0 (0.0%) 4 (9.8%)
 Phlegm 5 (17.9%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 5 (12.2%)
 Muscle Aches 2 (7.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (4.9%)
 Nausea4 2 (7.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (4.9%)
 Runny Nose 3 (10.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 3 (7.3%)
 Stomach Pain 0 (0.0%) 0 (0.0%) 2 (66.6%) 1 (50.0%) 3 (7.3%)
 Upset Stomach 0 (0.0%) 1 (12.5%) 0 (0.0%) 0 (0.0%) 1 (2.4%)
 Wheeze 2 (7.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (4.9%)
  1. 1 Denominator is the number of patients randomised in the study
  2. 2 Denominator is number of Side-effects on study
  3. 3 Patient initially recorded this over all 4 weeks, however related AE only covers period of first week
  4. 4 One patient recorded nausea in Week 1 diary and Week 2 diary, unsure if this is the same event
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