TABLE 3.
Manifestations and severity of ADRs of andrographolide derivative injections reported in the included RCTs, non-RCTs and case series.
| ADR manifestations | Number of ADRs with CTCAE grading | Total number of ADRs | Proportion (%) | Detailed description | Dosage (whether according to instructions) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G4 | G5 | Unclear | Lower | Yes | Higher | Unclear | ||||
| Gastrointestinal disorders (diarrhea, nausea, vomiting, stomachache) | 74 | 11 | 0 | 0 | 0 | 81 | 166 | 43.34 | AS: 101 | 4 | 89 | 3 | 5 |
| PSDS: 54 | 0 | 5 | 0 | 49 | |||||||||
| PDS: 11 | 0 | 5 | 0 | 6 | |||||||||
| Skin and subcutaneous tissue disorders (maculo-papular rash, urticaria, pruritus, flushing) | 26 | 3 | 0 | 0 | 0 | 95 | 124 | 32.38 | AS: 64 | 5 | 56 | 3 | 0 |
| PSDS: 51 | 0 | 0 | 0 | 51 | |||||||||
| PDS: 6 | 0 | 2 | 0 | 4 | |||||||||
| ASB: 1 | 0 | 0 | 0 | 1 | |||||||||
| AP: 2 | 0 | 0 | 0 | 2 | |||||||||
| Anaphylaxis (sweating, chest tightness, palpitation, hypotension, dyspnea, weak pulse, pale complexion) | 0 | 0 | 1 | 0 | 0 | 19 | 20 | 5.22 | AS: 11 | 3 | 8 | 0 | 0 |
| PDS: 5 | 0 | 5 | 0 | 0 | |||||||||
| Other: 4 | 0 | 0 | 0 | 4 | |||||||||
| General disorders and abnormal administration site conditions (pain at injection site, fever, chills, edema, children crying) | 0 | 11 | 0 | 0 | 0 | 5 | 16 | 4.18 | AS: 3 | 0 | 3 | 0 | 0 |
| PSDS: 13 | 0 | 0 | 0 | 13 | |||||||||
| Nervous system disorders (dizziness, headache, seizure, convulsion) | 3 | 0 | 0 | 0 | 0 | 9 | 12 | 3.13 | AS: 3 | 0 | 3 | 0 | 0 |
| PSDS: 3 | 0 | 0 | 0 | 3 | |||||||||
| PDS: 4 | 0 | 1 | 0 | 3 | |||||||||
| Other: 2 | 0 | 0 | 0 | 2 | |||||||||
| Blood and lymphatic system disorders (anemia) | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0.26 | AS: 1 | 0 | 1 | 0 | 0 |
| Abnormal investigation (Medical examination) results (decreased white blood cell, elevated transaminase) | 4 | 0 | 0 | 0 | 0 | 16 | 20 | 5.22 | AS: 8 | 0 | 8 | 0 | 0 |
| PSDS: 8 | 0 | 0 | 0 | 8 | |||||||||
| Other: 4 | 0 | 0 | 0 | 4 | |||||||||
| Unspecified anaphylactic reaction | 0 | 0 | 0 | 0 | 0 | 24 | 24 | 6.27 | AS: 7 | 0 | 6 | 0 | 1 |
| PSDS: 17 | 0 | 10 | 6 | 1 | |||||||||
| Total | 107 | 25 | 1 | 0 | 0 | 250 | 383 | 100.00 | |||||