Table 2.
Results of multiple logistic regression analysis for DOC15.
| Odds ratio | 95% Lower limit | 95% Upper limit | P value | P value | |
|---|---|---|---|---|---|
| Known AE | 1.00 | Reference | < 0.0001 | ||
| Unknown AEa | 3.35 | 2.16 | 5.20 | ||
| AE30 | 1.00 | Reference | < 0.0001 | ||
| AE15b | 0.24 | 0.18 | 0.32 | ||
| Domestic AE | 1.00 | Reference | < 0.0001 | ||
| Foreign AEc | 8.72 | 7.24 | 10.54 | ||
| MHA | |||||
| A | 1.00 | Reference | < 0.0001 | ||
| B | 1.96 | 1.53 | 2.55 | < 0.0001 | |
| C | 3.48 | 2.71 | 4.48 | < 0.0001 | |
| D | 0.66 | 0.41 | 1.04 | 0.0749 | |
| E | 3.30 | 1.95 | 5.58 | < 0.0001 | |
| F | 0.61 | 0.29 | 1.29 | 0.1971 | |
| G | 1.37 | 0.75 | 2.48 | 0.3033 | |
| H | 12.10 | 7.06 | 21.64 | < 0.0001 | |
| Others | 1.38 | 0.70 | 2.65 | 0.3440 | |
| Event category | |||||
| Device related | 1.00 | Reference | < 0.0001 | ||
| Device infection | 2.45 | 1.68 | 3.58 | < 0.0001 | |
| Patient related | 1.27 | 0.96 | 1.67 | 0.0904 | |
| Procedure related | 0.70 | 0.59 | 0.84 | 0.0001 | |
| Under investigation | 1.13 | 0.85 | 1.51 | 0.3871 | |
| Patient outcome | |||||
| No health damage | 1.00 | Reference | < 0.0001 | ||
| Recovered | 1.85 | 1.42 | 2.39 | < 0.0001 | |
| Unrecovered | 2.03 | 1.45 | 2.84 | < 0.0001 | |
| Death | 5.84 | 4.07 | 8.44 | < 0.0001 | |
| Observation or under treatment | 0.61 | 0.39 | 0.95 | 0.0303 | |
| Unknown or under investigation | 1.78 | 1.36 | 2.33 | < 0.0001 | |
| Device category | |||||
| Mechanical heart valve | 1.00 | Reference | < 0.0001 | ||
| Tissue heart valve | 0.64 | 0.45 | 0.92 | 0.0152 | |
| Prosthetic vascular graft | 2.61 | 0031.37 | 4.98 | 0.0038 | |
| Stent graft | 1.85 | 1.14 | 2.99 | 0.0129 | |
| Valved conduit | 0.65 | 0.37 | 1.12 | 0.1189 |
AE: adverse event. MAH: marketing authorization holder. DOC15: duration more than 15 days from the date the AE occurred to that when the MAH captured it. DCR: duration from the date when the MAH captured the AE to the date when the MAH reported it to the Pharmaceutical and Medical Device Agency. DCR of AE must be within 15 days, AE15 consists of a death or any serious health damage that has not been listed in labeling, and any domestic death event that has been already listed in labeling. AE30: DCR of AE must be within 30 days. AE30 consists of any serious health damage or foreign death event that is listed in labeling.
Associations between DOC15 and the seven variables were analyzed by multiple logistic regression analysis. The multivariate adjusted odds ratios (ORs) are expressed with 95% confidence interval (CI). P values of less than 0.05 are considered statistically significant.
The odds ratio of unknown AE refer to Known AE.
The odds ration of AE15 refer to AE 30.
The odds ration of foreign AE refer to domestic AE.