eTable 3. The ten most frequent ADRs reported by physicians and patients.
Rank |
Physicians: most frequently reported ADRs |
Proportion in physician reports (n = 221 427) in % (number of spontaneous reports) |
Rank |
Patients:
most frequently reported ADRs |
Proportion in patient reports (n = 32 992) in % (number of spontaneous reports) |
|
1. | Nausea* | 4.7 % (10 382) | 1. | Dizziness* | 7.1% (2346) | |
2. | Pruritus* | 3.5% (7734) | 2. | Nausea* | 6.3% (2074) | |
3. | Dyspnea* | 3.1% (6876) | 3. | Headache | 5.3% (1747) | |
4. | Vomiting | 2.8% (6267) | 4. | Fatigue | 5.1% (1696) | |
5. | Pyrexia | 2.8% (6262) | 5. | Dyspnoea* | 4.6% (1527) | |
6. | Dizziness* | 2.8% (6256) | 6. | Diarrhea* | 4.1% (1353) | |
7. | Thrombocytopenia | 2.7% (6009) | 7. | Pruritus* | 3.7% (1209) | |
8. | Urticaria | 2.6% (5721) | 8. | Visual impairment | 3.4% (1135) | |
9. | Skin rash | 2.6% (5681) | 9. | Asthenia | 3.3% (1088) | |
10. | Diarrhea* | 2.3% (5180) | 10. | Arthralgia | 3.1% (1038) |
The ten most frequently reported ADRs in spontaneous reports from physicians (n = 221 427) and patients (n = 32 992) are shown as the percentage share of the corresponding dataset (e.g., for physicians or patients) and their absolute number (in brackets).
ADRs that are in the top ten for both physicians and patients are indicated with an asterisk (*). As a report may describe several ADRs, the number of reported ADRs exceeds the total number of reports. The remaining ADRs (until #50) are not listed here.
For the analysis presented in eTable 3, ADRs were chosen at the fourth level (PT, preferred term) of the MedDRA (Medical Dictionary for Regulatory Activities) terminology.