Comparison of analyses by data mining of the FDA AERS database to the results of analysis by clinical criteria in published case reports and by identification of drug-dependent, platelet-reactive antibodies for 1468 drugs that were suspected causes of thrombocytopenia
| Data mining (n = 1444) . | Clinical and/or laboratory evidence (n = 351) . | Not reported/tested (n = 1117) . | Total (n = 1468) . | |
|---|---|---|---|---|
| + . | − . | |||
| + | 91 | 112 | 370 | 573 |
| − | 30 | 94 | 747 | 871 |
| Not described (n = 24) | 9 | 15 | 0 | 24 |
| Total | 130 | 221 | 1117 | 1468 |
| Data mining (n = 1444) . | Clinical and/or laboratory evidence (n = 351) . | Not reported/tested (n = 1117) . | Total (n = 1468) . | |
|---|---|---|---|---|
| + . | − . | |||
| + | 91 | 112 | 370 | 573 |
| − | 30 | 94 | 747 | 871 |
| Not described (n = 24) | 9 | 15 | 0 | 24 |
| Total | 130 | 221 | 1117 | 1468 |
Data mining analysis of the FDA AERS database compared with the results of analysis by clinical criteria in published case reports and by identification of drug-dependent, platelet-reactive antibodies for 1468 drugs that were suspected causes of thrombocytopenia. A total of 130 drugs had evidence for a causal association with thrombocytopenia by either published case reports and/or detection of drug-dependent platelet reactive antibodies (first column); 573 drugs had a statistically significant reporting association with thrombocytopenia by data mining (top row); and 91 drugs had evidence for causal association by case reports and/or laboratory analysis and data mining (top left cell). In addition to these 91 drugs, 521 drugs (112 + 370 in the first row and 30 + 9 in the first column) had evidence for a causal association with thrombocytopenia by either published case reports and/or detection of drug-dependent platelet reactive antibodies or by data mining. Therefore, a total of 612 drugs (91 + 521) had evidence for causal association by 1 or more of the 3 methods.
+ indicates a statistically significant reporting association with thrombocytopenia by data mining or evidence for a causal association with thrombocytopenia by clinical evidence and/or by detection of drug-dependent antibodies; and −, the absence of a statistically significant reporting association with thrombocytopenia or the absence of clinical and laboratory evidence for a causal association with thrombocytopenia.