Table 3.
Comparison of adverse drug reaction (ADR) reports caused and not caused by actual drug-drug interactions (DDI)
| Characteristic | Median (range) or number (%) of ADR reports* |
P | |
|---|---|---|---|
| not caused by DDIs | caused by DDIs | ||
| Number of drugs prescribed |
2 (1-14) |
4 (2-12) |
<0.001 |
| Patient age |
55 y (1 days-93 years) |
58 y (3 days-85 years) |
0.115 |
| Patients’ sex: |
|||
| female |
1270 (64.1) |
53 (56.4) |
0.535 |
| male |
712 (35.9) |
41 (43.6) |
|
| Seriousness of ADR:* |
|||
| serious |
580 (29.3) |
53 (56.4) |
<0.001 |
| not serious | 1402 (70.7) | 41 (43.6) | |
*Serious adverse drug reactions were those that resulted in the following outcomes according to the ICH E 2A (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) guideline (44): death, life threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other important medical event according to CIOMS V (Council for International Organizations of Medical Sciences 2001).