Table 4. AE occurrence for patients using Yunnan Baiyao capsules.
| Categories by coding | Frequency (cases) | Incidence (ITT) (%) | Incidence (PP) (%) | Proportion (%) |
|---|---|---|---|---|
| Nasopharyngitis | 92 | 0.89 | 0.29 | 11.92 |
| Fever | 76 | 0.84 | 0.24 | 9.84 |
| Diarrhea | 61 | 0.79 | 0.19 | 7.90 |
| Nausea | 52 | 0.76 | 0.17 | 6.74 |
| Dizziness | 37 | 0.71 | 0.12 | 4.79 |
| Rash | 34 | 0.70 | 0.11 | 4.40 |
| Wound | 33 | 0.70 | 0.11 | 4.27 |
| Epigastric discomfort | 31 | 0.69 | 0.10 | 4.02 |
| Flatulence | 26 | 0.68 | 0.08 | 3.37 |
| Vomiting | 26 | 0.68 | 0.08 | 3.37 |
| Cough | 22 | 0.67 | 0.07 | 2.85 |
| Epigastric pain | 21 | 0.66 | 0.07 | 2.72 |
| Upper respiratory infection | 15 | 0.64 | 0.05 | 1.94 |
| Allergic dermatitis | 13 | 0.64 | 0.04 | 1.68 |
| Chest discomfort | 12 | 0.63 | 0.04 | 1.55 |
| Constipation | 12 | 0.63 | 0.04 | 1.55 |
| Headache | 12 | 0.63 | 0.04 | 1.55 |
| Itching | 12 | 0.63 | 0.04 | 1.55 |
| Abdominal pain | 10 | 0.63 | 0.03 | 1.30 |
| Dyspepsia | 9 | 0.62 | 0.03 | 1.17 |
| Parulis | 9 | 0.62 | 0.03 | 1.17 |
| Oral ulcer | 8 | 0.62 | 0.03 | 1.04 |
| Palpitation | 7 | 0.62 | 0.02 | 0.91 |
| Urticaria | 7 | 0.62 | 0.02 | 0.91 |
| Loss of appetite | 6 | 0.61 | 0.02 | 0.78 |
| Abdominal discomfort | 5 | 0.61 | 0.02 | 0.65 |
| Drug hypersensitivity | 5 | 0.61 | 0.02 | 0.65 |
| Gastroesophageal reflux | 5 | 0.61 | 0.02 | 0.65 |
| Uncomfortable | 5 | 0.61 | 0.02 | 0.65 |
| Asthenia | 4 | 0.61 | 0.01 | 0.52 |
| Gastrointestinal diseases | 4 | 0.61 | 0.01 | 0.52 |
| Pain | 4 | 0.61 | 0.01 | 0.52 |
| Postoperative hemorrhage | 4 | 0.61 | 0.01 | 0.52 |
| Running nose | 4 | 0.61 | 0.01 | 0.52 |
| Thermal burn | 4 | 0.61 | 0.01 | 0.52 |
| Bleeding | 3 | 0.61 | 0.01 | 0.39 |
| Insomnia | 3 | 0.61 | 0.01 | 0.39 |
| Joint pain | 3 | 0.61 | 0.01 | 0.39 |
| Dry throat | 2 | 0.60 | 0.01 | 0.26 |
| Eczema | 2 | 0.60 | 0.01 | 0.26 |
| Erythropoiesis | 2 | 0.60 | 0.01 | 0.26 |
| Hypoglycemia | 2 | 0.60 | 0.01 | 0.26 |
| Phlebitis | 2 | 0.60 | 0.01 | 0.26 |
| Shortness of breath | 2 | 0.60 | 0.01 | 0.26 |
| Stuffy nose | 2 | 0.60 | 0.01 | 0.26 |
| Acne | 1 | 0.60 | 0.00 | 0.13 |
| Acute gastroenteritis | 1 | 0.60 | 0.00 | 0.13 |
| Allergic rhinitis | 1 | 0.60 | 0.00 | 0.13 |
| Amaurosis | 1 | 0.60 | 0.00 | 0.13 |
| Amygdalitis | 1 | 0.60 | 0.00 | 0.13 |
| Allergic shock | 1 | 0.60 | 0.00 | 0.13 |
| Ankle sprains | 1 | 0.60 | 0.00 | 0.13 |
| Chronic gastritis | 1 | 0.60 | 0.00 | 0.13 |
| Decubitus ulcer | 1 | 0.60 | 0.00 | 0.13 |
| Drowsiness | 1 | 0.60 | 0.00 | 0.13 |
| Dry mouth | 1 | 0.60 | 0.00 | 0.13 |
| Dysphonia | 1 | 0.60 | 0.00 | 0.13 |
| Dysuria | 1 | 0.60 | 0.00 | 0.13 |
| Epistaxis | 1 | 0.60 | 0.00 | 0.13 |
| Erythema | 1 | 0.60 | 0.00 | 0.13 |
| Eye hyperaemia | 1 | 0.60 | 0.00 | 0.13 |
| Eyelid edema | 1 | 0.60 | 0.00 | 0.13 |
| Flush | 1 | 0.60 | 0.00 | 0.13 |
| Gastrointestinal disorder | 1 | 0.60 | 0.00 | 0.13 |
| Gum swelling | 1 | 0.60 | 0.00 | 0.13 |
| Hemoptysis | 1 | 0.60 | 0.00 | 0.13 |
| Hemorrhoid bleeding | 1 | 0.60 | 0.00 | 0.13 |
| High blood pressure | 1 | 0.60 | 0.00 | 0.13 |
| Hypertrophy of tonsil | 1 | 0.60 | 0.00 | 0.13 |
| Hyperuricemia | 1 | 0.60 | 0.00 | 0.13 |
| Hypoesthesia | 1 | 0.60 | 0.00 | 0.13 |
| Internal fixation of fracture | 1 | 0.60 | 0.00 | 0.13 |
| Numb lips | 1 | 0.60 | 0.00 | 0.13 |
| Melena | 1 | 0.60 | 0.00 | 0.13 |
| Menorrhagia | 1 | 0.60 | 0.00 | 0.13 |
| Menstruation delay | 1 | 0.60 | 0.00 | 0.13 |
| Slow micturition | 1 | 0.60 | 0.00 | 0.13 |
| Numbness after administration contact | 1 | 0.60 | 0.00 | 0.13 |
| Oliguria | 1 | 0.60 | 0.00 | 0.13 |
| Oropharyngeal pain | 1 | 0.60 | 0.00 | 0.13 |
| Otitis media | 1 | 0.60 | 0.00 | 0.13 |
| Panmetatarsal pain syndrome | 1 | 0.60 | 0.00 | 0.13 |
| Peripheral edema | 1 | 0.60 | 0.00 | 0.13 |
| Physical pain | 1 | 0.60 | 0.00 | 0.13 |
| Postoperative wound infection | 1 | 0.60 | 0.00 | 0.13 |
| Purulent sputum | 1 | 0.60 | 0.00 | 0.13 |
| Radial fracture | 1 | 0.60 | 0.00 | 0.13 |
| Red skin | 1 | 0.60 | 0.00 | 0.13 |
| Scapulohumeral periarthritis | 1 | 0.60 | 0.00 | 0.13 |
| Petechia | 1 | 0.60 | 0.00 | 0.13 |
| Skin and subcutaneous tissue disease | 1 | 0.60 | 0.00 | 0.13 |
| Skin disease | 1 | 0.60 | 0.00 | 0.13 |
| Sneezing | 1 | 0.60 | 0.00 | 0.13 |
| Sore eyes | 1 | 0.60 | 0.00 | 0.13 |
| Stomach bleeding | 1 | 0.60 | 0.00 | 0.13 |
| Tachycardia | 1 | 0.60 | 0.00 | 0.13 |
| Tailbone pain | 1 | 0.60 | 0.00 | 0.13 |
| Throat discomfort | 1 | 0.60 | 0.00 | 0.13 |
| Throat pain | 1 | 0.60 | 0.00 | 0.13 |
| Tinnitus | 1 | 0.60 | 0.00 | 0.13 |
| Toothache | 1 | 0.60 | 0.00 | 0.13 |
| Unstable blood pressure | 1 | 0.60 | 0.00 | 0.13 |
| Urinary retention | 1 | 0.60 | 0.00 | 0.13 |
| Urine erythrocyte positive | 1 | 0.60 | 0.00 | 0.13 |
| Urogenital hemorrhage | 1 | 0.60 | 0.00 | 0.13 |
| Vaginal bleeding | 1 | 0.60 | 0.00 | 0.13 |
| Wound infection | 1 | 0.60 | 0.00 | 0.13 |
| Total | 772 | 3.04 | 2.46 | 100.00 |
AE, adverse event; PP, per-protocol; ITT, intention-to-treat.