Table 2.
Characteristics of the adverse drug reactions (ADRs) entered as free text and selected from the patient-friendly terms list
| Overall | Reports in which ADRs were entered as free text | Reports in which ADRs were selected from the patient-friendly terms list | P valuea | |
|---|---|---|---|---|
| Number of ADRs at the LLT level | 3227 | 2545 | 682 | |
| Overall, 10 most commonly reported ADRs (% of number of ADRs at the LLT level) | ||||
| Nausea | 78 (2.4) | 54 (2.1) | 24 (3.5) | 0.035 |
| Headache | 77 (2.4) | 65 (2.6) | 12 (1.8) | 0.227 |
| Diarrhoea | 62 (1.9) | 36 (1.4) | 26 (3.8) | < 0.001 |
| Dizziness | 54 (1.7) | 36 (1.4) | 18 (2.6) | 0.027 |
| Insomnia | 33 (1.0) | 20 (0.8) | 13 (1.9) | 0.010 |
| Anxiety | 29 (0.9) | 21 (0.8) | 8 (1.2) | 0.393 |
| Depression | 28 (0.9) | 28 (1.1) | 0 (0.0)b | 0.002c |
| Fatigue | 28 (0.9) | 23 (0.9) | 5 (0.7) | 0.670 |
| Tiredness | 28 (0.9) | 22 (0.9) | 6 (0.9) | 0.969 |
| Vomiting | 28 (0.9) | 19 (0.8) | 9 (1.3) | 0.152 |
| Appetite lost | 26 (0.8) | 21 (0.8) | 5 (0.7) | 0.811 |
| Joint pain | 24 (0.7) | 18 (0.7) | 6 (0.9) | 0.641 |
| Chest pain | 23 (0.7) | 18 (0.7) | 5 (0.7) | 0.943 |
| Constipation | 21 (0.7) | 11 (0.4) | 10 (1.5) | 0.003 |
| Pain | 21 (0.7) | 21 (0.8) | 0 (0) | 0.013c |
LLT lowest level term
aMeasured using Chi-squared tests
bThis ADR was not on the patient-friendly terms list
cMeasured using the Fisher’s exact test